Trial Outcomes & Findings for Jump-In: Building Better Bones (NCT NCT00729378)
NCT ID: NCT00729378
Last Updated: 2025-10-28
Results Overview
Baseline to 12-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm\^2).
COMPLETED
NA
509 participants
Baseline to 12-months
2025-10-28
Participant Flow
Recruitment was performed for three years (2007-2009) in a total of 16 elementary and middle schools (9 intervention and 7 control) in two Tucson, Arizona area school districts. Recruitment consisted of attending back to school days and holding recruitment assemblies before or after school.
Intervention and control schools designated prior to recruiting. Schools were selected based on size, demographics, and student flow from elementary to middle school to prevent contamination. 739 participants completed informed consent process (agreed to participate); only 509 scheduled measurement appointments and completed study measurements.
Participant milestones
| Measure |
Exercise Intervention
Subjects in the exercise intervention arm performed activities designed to provide skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
Control
Subjects in the control arm did not take part in intervention exercises. Physical activity performed by these subjects was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline
STARTED
|
430
|
309
|
|
Baseline
COMPLETED
|
292
|
217
|
|
Baseline
NOT COMPLETED
|
138
|
92
|
|
12-months
STARTED
|
292
|
217
|
|
12-months
COMPLETED
|
192
|
152
|
|
12-months
NOT COMPLETED
|
100
|
65
|
|
24-months
STARTED
|
192
|
152
|
|
24-months
COMPLETED
|
120
|
101
|
|
24-months
NOT COMPLETED
|
72
|
51
|
|
36-months
STARTED
|
120
|
101
|
|
36-months
COMPLETED
|
105
|
95
|
|
36-months
NOT COMPLETED
|
15
|
6
|
Reasons for withdrawal
| Measure |
Exercise Intervention
Subjects in the exercise intervention arm performed activities designed to provide skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
Control
Subjects in the control arm did not take part in intervention exercises. Physical activity performed by these subjects was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline
Did not complete study measurements
|
72
|
33
|
|
Baseline
Withdrawal by Subject
|
66
|
59
|
|
12-months
Lost to Follow-up
|
100
|
65
|
|
24-months
Lost to Follow-up
|
72
|
51
|
|
36-months
Lost to Follow-up
|
15
|
6
|
Baseline Characteristics
Jump-In: Building Better Bones
Baseline characteristics by cohort
| Measure |
Exercise Intervention
n=292 Participants
Subjects in the exercise intervention arm performed activities designed to provide skeletal loading: impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
Control
n=217 Participants
Subjects in the control arm did not take part in intervention exercises. Physical activity performed by these subjects was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
Total
n=509 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.6 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
10.7 years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
10.7 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
292 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
509 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
67 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
225 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
392 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
254 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
292 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
509 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of total volumetric bone density at the femur 4% site. Measurement made by peripheral quantitative computed tomography (pQCT) at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Total Volumetric Bone Density at the Femur 4% Site
|
270.79 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 32.97
|
277.25 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 33.83
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
|
232.34 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 31.56
|
239.32 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 32.2
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Volumetric Bone Density of Cortical Bone at the Femur 4% Site
|
267.89 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 30.75
|
273.80 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 31.23
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Trabecular Bone Area at the Femur 4% Site
|
1053.15 millimeters squared (mm^2)
Standard Deviation 227.32
|
1039.55 millimeters squared (mm^2)
Standard Deviation 220.17
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Cortical Bone Area at the Femur 4% Site
|
1348.65 millimeters squared (mm^2)
Standard Deviation 284.24
|
1335.56 millimeters squared (mm^2)
Standard Deviation 274.22
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Periosteal Circumference at the Femur 4% Site
|
125.63 millimeters (mm)
Standard Deviation 12.50
|
124.91 millimeters (mm)
Standard Deviation 12.42
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm\^4.
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Bone Strength Index at the Femur 4% Site
|
93.52 mm^4
Standard Deviation 27.39
|
96.77 mm^4
Standard Deviation 28.00
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Total Volumetric Bone Density at the Femur 20% Site
|
478.72 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 60.59
|
489.70 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 63.98
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
|
153.11 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 36.77
|
163.81 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 39.43
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Volumetric Bone Density of Cortical Bone at the Femur 20% Site
|
1045.20 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 23.07
|
1046.01 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 22.27
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Periosteal Circumference at the Femur 20% Site
|
77.78 millimeters (mm)
Standard Deviation 8.66
|
77.43 millimeters (mm)
Standard Deviation 8.56
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of cortical thickness at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Cortical Thickness at the Femur 20% Site
|
2.50 millimeters (mm)
Standard Deviation .35
|
2.52 millimeters (mm)
Standard Deviation .37
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of stress-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm\^3.
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Stress-Strain Index at the Femur 20% Site
|
1344.66 mm^3
Standard Deviation 399.31
|
1340.19 mm^3
Standard Deviation 404.78
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
|
219.74 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 25.56
|
224.03 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 27.58
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Total Volumetric Bone Density at the Tibia 4% Site
|
291.62 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 33.17
|
297.27 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 37.02
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
|
291.93 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 31.92
|
297.40 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 35.63
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Trabecular Bone Area at the Tibia 4% Site
|
475.80 millimeters squared (mm^2)
Standard Deviation 108.85
|
467.73 millimeters squared (mm^2)
Standard Deviation 100.86
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Cortical Bone Area at the Tibia 4% Site
|
625.57 millimeters squared (mm^2)
Standard Deviation 127.11
|
617.19 millimeters squared (mm^2)
Standard Deviation 117.67
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Periosteal Circumference at the Tibia 4% Site
|
86.43 millimeters (mm)
Standard Deviation 8.82
|
85.86 millimeters (mm)
Standard Deviation 8.36
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm\^4.
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Bone Strength Index at the Tibia 4% Site
|
51.03 mm^4
Standard Deviation 13.63
|
52.45 mm^4
Standard Deviation 15.15
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Total Volumetric Bone Density at the Tibia 50% Site
|
736.33 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 58.07
|
745.69 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 59.54
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
|
131.63 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 26.97
|
137.39 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 26.83
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
|
1070.95 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 31.93
|
1070.32 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 32.88
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Periosteal Circumference at the Tibia 50% Site
|
62.33 millimeters (mm)
Standard Deviation 5.83
|
61.98 millimeters (mm)
Standard Deviation 5.43
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Cortical Thickness at the Tibia 50% Site
|
4.00 millimeters (mm)
Standard Deviation .54
|
4.05 millimeters (mm)
Standard Deviation .58
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of stress-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm\^3.
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Stress-Strain Index at the Tibia 50% Site
|
1023.74 mm^3
Standard Deviation 297.42
|
1004.97 mm^3
Standard Deviation 272.40
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Total Volumetric Bone Density at the Tibia 66% Site
|
552.71 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 61.05
|
566.04 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 63.11
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
|
152.34 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 28.73
|
159.04 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 30.48
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
|
1026.07 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 31.38
|
1029.42 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 32.92
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Periosteal Circumference at the Tibia 66% Site
|
72.34 millimeters (mm)
Standard Deviation 7.25
|
71.55 millimeters (mm)
Standard Deviation 6.53
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Cortical Thickness at the Tibia 66% Site
|
3.02 millimeters (mm)
Standard Deviation .46
|
3.06 millimeters (mm)
Standard Deviation .49
|
PRIMARY outcome
Timeframe: BaselinePopulation: Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).
Baseline (initial) measurement of strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm\^3.
Outcome measures
| Measure |
Control
n=217 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=286 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
Baseline Stress-Strain Index at the Tibia 66% Site
|
1187.31 mm^3
Standard Deviation 353.09
|
1167.94 mm^3
Standard Deviation 331.61
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Total Volumetric Bone Density the Femur 4% Site
|
2.83 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 12.32
|
3.10 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 15.36
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
|
5.89 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 12.94
|
3.37 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 15.23
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site
|
1.68 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 11.47
|
2.14 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 14.47
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Trabecular Bone Area at the Femur 4% Site
|
144.97 millimeters squared (mm^2)
Standard Deviation 96.38
|
104.16 millimeters squared (mm^2)
Standard Deviation 111.80
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Cortical Bone Area at the Femur 4% Site
|
185.50 millimeters squared (mm^2)
Standard Deviation 119.42
|
140.00 millimeters squared (mm^2)
Standard Deviation 131.17
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Periosteal Circumference at the Femur 4% Site
|
8.09 millimeters (mm)
Standard Deviation 4.84
|
6.17 millimeters (mm)
Standard Deviation 5.80
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm\^4.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Bone Strength Index at the Femur 4% Site
|
15.03 mm^4
Standard Deviation 14.19
|
12.84 mm^4
Standard Deviation 12.67
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Total Volumetric Bone Density at the Femur 20% Site
|
-2.46 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 18.74
|
2.40 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 22.38
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
|
5.77 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 12.38
|
7.12 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 12.98
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site
|
4.39 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 19.38
|
6.87 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 20.02
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Thickness of Cortical Bone at the Femur 20% Site
|
.11 millimeters (mm)
Standard Deviation .15
|
.11 millimeters (mm)
Standard Deviation .17
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Periosteal Circumference at the Femur 20% Site
|
5.65 millimeters (mm)
Standard Deviation 2.20
|
4.89 millimeters (mm)
Standard Deviation 2.21
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm\^3.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Stress-Strain Index at the Femur 20% Site
|
297.43 mm^3
Standard Deviation 145.31
|
261.94 mm^3
Standard Deviation 137.73
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Total Volumetric Bone Density at the Tibia 4% Site
|
10.34 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 19.34
|
9.87 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 17.29
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
|
2.36 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 9.33
|
2.84 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 10.22
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
|
10.10 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 18.73
|
9.69 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 16.76
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Trabecular Bone Area at the Tibia 4% Site
|
24.65 millimeters squared (mm^2)
Standard Deviation 50.00
|
29.87 millimeters squared (mm^2)
Standard Deviation 52.91
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Cortical Bone Area at the Tibia 4% Site
|
39.53 millimeters squared (mm^2)
Standard Deviation 49.12
|
44.85 millimeters squared (mm^2)
Standard Deviation 54.14
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Periosteal Circumference at the Tibia 4% Site
|
2.77 millimeters (mm)
Standard Deviation 3.44
|
3.17 millimeters (mm)
Standard Deviation 3.70
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm\^4.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Bone Strength Index at the Tibia 4% Site
|
7.46 mm^4
Standard Deviation 5.53
|
7.84 mm^4
Standard Deviation 5.39
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Total Volumetric Bone Density at the Tibia 50% Site
|
17.76 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 22.02
|
17.98 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 22.27
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
|
-3.16 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 15.63
|
-2.74 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 13.55
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
|
11.16 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 18.91
|
14.34 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 22.23
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Periosteal Circumference at the Tibia 50% Site
|
3.11 millimeters (mm)
Standard Deviation 1.09
|
2.98 millimeters (mm)
Standard Deviation 1.33
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Cortical Thickness at the Tibia 50% Site
|
.31 millimeters (mm)
Standard Deviation .20
|
.29 millimeters (mm)
Standard Deviation .20
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm\^3.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Stress-Strain Index at the Tibia 50% Site
|
185.36 mm^3
Standard Deviation 79.04
|
171.82 mm^3
Standard Deviation 68.00
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Total Volumetric Bone Density at the Tibia 66% Site
|
9.58 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 29.98
|
7.00 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 32.41
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
|
2.08 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 14.64
|
3.40 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 13.49
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=9 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
|
12.69 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 21.32
|
11.63 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 24.00
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Periosteal Circumference at the Tibia 66% Site
|
3.79 millimeters (mm)
Standard Deviation 2.06
|
3.69 millimeters (mm)
Standard Deviation 2.35
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Cortical Thickness at the Tibia 66% Site
|
.18 millimeters (mm)
Standard Deviation .22
|
.17 millimeters (mm)
Standard Deviation .21
|
PRIMARY outcome
Timeframe: Baseline to 12-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 12-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm\^3.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
12-month Change in Stress-Strain Index at the Tibia 66% Site
|
228.46 mm^3
Standard Deviation 103.48
|
214.93 mm^3
Standard Deviation 96.58
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units mg/ccm.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month in Change in Total Volumetric Bone Density the Femur 4% Site
|
13.47 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 19.09
|
13.70 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 22.89
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month in Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
|
8.23 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 16.35
|
8.03 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 19.34
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month in Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site
|
10.78 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 17.95
|
10.67 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 21.83
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Trabecular Bone Area at the Femur 4% Site
|
178.04 millimeters squared (mm^2)
Standard Deviation 146.00
|
160.89 millimeters squared (mm^2)
Standard Deviation 158.53
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Cortical Bone Area at the Femur 4% Site
|
255.67 millimeters squared (mm^2)
Standard Deviation 165.23
|
237.12 millimeters squared (mm^2)
Standard Deviation 178.61
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Periosteal Circumference at the Femur 4% Site
|
10.72 millimeters (mm)
Standard Deviation 6.88
|
10.08 millimeters (mm)
Standard Deviation 7.73
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm\^4.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Bone Strength Index at the Femur 4% Site
|
27.81 mm^4
Standard Deviation 17.76
|
28.08 mm^4
Standard Deviation 17.51
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Total Volumetric Bone Density at the Femur 20% Site
|
15.36 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 28.47
|
14.88 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 31.73
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
|
9.04 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 13.87
|
11.83 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 17.20
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site
|
22.26 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 29.62
|
21.56 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 29.46
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Thickness of Cortical Bone at the Femur 20% Site
|
.31 millimeters (mm)
Standard Deviation .21
|
.27 millimeters (mm)
Standard Deviation .22
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Periosteal Circumference at the Femur 20% Site
|
9.29 millimeters (mm)
Standard Deviation 3.08
|
8.25 millimeters (mm)
Standard Deviation 3.38
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm\^3.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Stress-Strain Index at the Femur 20% Site
|
582.69 mm^3
Standard Deviation 202.42
|
504.12 mm^3
Standard Deviation 202.34
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Total Volumetric Bone Density at the Tibia 4% Site
|
26.76 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 29.35
|
28.22 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 30.58
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
|
7.23 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 17.18
|
7.37 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 13.97
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
|
25.94 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 28.46
|
27.29 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 29.54
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Trabecular Bone Area at the Tibia 4% Site
|
35.83 millimeters squared (mm^2)
Standard Deviation 75.98
|
34.81 millimeters squared (mm^2)
Standard Deviation 70.70
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm\^2).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Cortical Bone Area at the Tibia 4% Site
|
66.42 millimeters squared (mm^2)
Standard Deviation 73.94
|
65.50 millimeters squared (mm^2)
Standard Deviation 69.84
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Periosteal Circumference at the Tibia 4% Site
|
4.65 millimeters (mm)
Standard Deviation 5.15
|
4.64 millimeters (mm)
Standard Deviation 4.82
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm\^4.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Bone Strength Index at the Tibia 4% Site
|
16.86 mm^4
Standard Deviation 10.14
|
17.28 mm^4
Standard Deviation 9.35
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Total Volumetric Bone Density at the Tibia 50% Site
|
39.83 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 32.94
|
37.26 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 29.74
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
|
-4.00 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 14.16
|
-3.51 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 15.84
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
|
31.06 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 26.75
|
33.70 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 27.35
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Periosteal Circumference at the Tibia 50% Site
|
5.27 millimeters (mm)
Standard Deviation 1.63
|
5.26 millimeters (mm)
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Cortical Thickness at the Tibia 50% Site
|
.53 millimeters (mm)
Standard Deviation .28
|
.51 millimeters (mm)
Standard Deviation .28
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm\^3.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Stress-Strain Index at the Tibia 50% Site
|
336.49 mm^3
Standard Deviation 112.47
|
322.78 mm^3
Standard Deviation 114.10
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Total Volumetric Bone Density at the Tibia 66% Site
|
19.26 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 41.46
|
17.83 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 38.18
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
|
1.69 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 16.02
|
4.48 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 14.20
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
|
31.06 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 28.49
|
28.96 milligrams per cubic centimeter (mg/ccm)
Standard Deviation 28.71
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Periosteal Circumference at the Tibia 66% Site
|
6.82 millimeters (mm)
Standard Deviation 3.06
|
6.75 millimeters (mm)
Standard Deviation 3.07
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Cortical Thickness at the Tibia 66% Site
|
.32 millimeters (mm)
Standard Deviation .31
|
.32 millimeters (mm)
Standard Deviation .27
|
PRIMARY outcome
Timeframe: Baseline to 24-monthsPopulation: Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.
Baseline to 24-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm\^3.
Outcome measures
| Measure |
Control
n=98 Participants
Participants randomized to the control arm did not perform intervention activities. Physical activity was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire (PYPAQ).
|
Exercise Intervention
n=109 Participants
Participants randomized to the exercise intervention group performed activities designed to provide skeletal loading: impact activities 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months). New activities were introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
Physical activity performed by these subjects (in addition to intervention activities) was objectively assessed by pedometer (7-day wear period) and further assessed by a validated past year physical activity questionnaire PYPAQ).
|
|---|---|---|
|
24-month Change in Stress-Strain Index at the Tibia 66% Site
|
435.13 mm^3
Standard Deviation 164.78
|
421.49 mm^3
Standard Deviation 172.67
|
Adverse Events
Exercise Intervention Arm
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place