Trial Outcomes & Findings for Effects of Exercise Training Intensity on Fitness and Insulin Sensitivity in African Americans (NCT NCT02892331)
NCT ID: NCT02892331
Last Updated: 2024-06-13
Results Overview
Fitness will be measured using a modified Balke protocol on a treadmill. Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes. The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion. Maximal oxygen consumption (Liters of O2 per minute) will be measured using a True Max 2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2024-06-13
Participant Flow
The HI-PACE study was conducted in Greenville, NC at East Carolina University. Participants were recruited from the local Greenville, NC and Pitt County areas. Methods of recruitment included sending information to mailing list of local agencies, working with community partners, the ECU health disparity center, social media advertisements and local newspaper advertisements. Recruitment for the study began in Fall of 2016
individuals interested in study participation came in for a screening visit to determine initial eligibility. After this, those that remained eligible, did a "run-in" period where they wore an accelerometer for 7 consecutive days. When they returned with their accelerometer, a blood draw was performed for screening labs. After this, participants were scheduled for primary and secondary outcome measures. After completion of these outcomes measures, they were randomized to study groups.
Participant milestones
| Measure |
Control (CON)
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Training (MOD-INT)
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Training (HIGH-INT)
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
18
|
|
Overall Study
COMPLETED
|
16
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
Reasons for withdrawal
| Measure |
Control (CON)
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Training (MOD-INT)
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Training (HIGH-INT)
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Sick family member
|
0
|
0
|
1
|
|
Overall Study
Corona virus pandemic
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Blood pressure was too elevated
|
0
|
1
|
0
|
|
Overall Study
participant did not disclose she had an excluded medical condition and was disenrolled
|
0
|
1
|
0
|
Baseline Characteristics
Effects of Exercise Training Intensity on Fitness and Insulin Sensitivity in African Americans
Baseline characteristics by cohort
| Measure |
Control (CON)
n=18 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity (MOD-INT)
n=16 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise (HIGH-INT)
n=18 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 7.1 • n=99 Participants
|
50.2 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
48.0 years
STANDARD_DEVIATION 8.0 • n=206 Participants
|
49.3 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
16 participants
n=107 Participants
|
18 participants
n=206 Participants
|
52 participants
n=7 Participants
|
|
Body mass index
|
32.9 kg/m^2
STANDARD_DEVIATION 6.2 • n=99 Participants
|
35.6 kg/m^2
STANDARD_DEVIATION 4.8 • n=107 Participants
|
36.8 kg/m^2
STANDARD_DEVIATION 5.8 • n=206 Participants
|
35.1 kg/m^2
STANDARD_DEVIATION 5.8 • n=7 Participants
|
|
Weight
|
90.7 kg
STANDARD_DEVIATION 17.0 • n=99 Participants
|
98.7 kg
STANDARD_DEVIATION 13.6 • n=107 Participants
|
104.9 kg
STANDARD_DEVIATION 20.7 • n=206 Participants
|
98.1 kg
STANDARD_DEVIATION 18.2 • n=7 Participants
|
|
Systolic blood pressure
|
128.5 mmHg
STANDARD_DEVIATION 13.6 • n=99 Participants
|
129.8 mmHg
STANDARD_DEVIATION 10.8 • n=107 Participants
|
133.9 mmHg
STANDARD_DEVIATION 12.6 • n=206 Participants
|
130.8 mmHg
STANDARD_DEVIATION 12.6 • n=7 Participants
|
|
Diastolic blood pressure
|
81.8 mmHg
STANDARD_DEVIATION 10.9 • n=99 Participants
|
83.1 mmHg
STANDARD_DEVIATION 9.6 • n=107 Participants
|
85.1 mmHg
STANDARD_DEVIATION 8.8 • n=206 Participants
|
83.3 mmHg
STANDARD_DEVIATION 9.7 • n=7 Participants
|
|
Cardiorespiratory fitness (L/min)
|
2.0 L/min
STANDARD_DEVIATION 0.6 • n=99 Participants
|
1.8 L/min
STANDARD_DEVIATION 0.4 • n=107 Participants
|
2.0 L/min
STANDARD_DEVIATION 0.6 • n=206 Participants
|
1.9 L/min
STANDARD_DEVIATION 0.5 • n=7 Participants
|
|
Cardiorespiratory fitness (mL/kg/min)
|
21.6 mL/kg/min
STANDARD_DEVIATION 6.0 • n=99 Participants
|
18.5 mL/kg/min
STANDARD_DEVIATION 4.3 • n=107 Participants
|
18.7 mL/kg/min
STANDARD_DEVIATION 3.8 • n=206 Participants
|
19.5 mL/kg/min
STANDARD_DEVIATION 4.9 • n=7 Participants
|
|
Glucose
|
93.3 mg/dL
STANDARD_DEVIATION 10.5 • n=99 Participants
|
93.2 mg/dL
STANDARD_DEVIATION 6.9 • n=107 Participants
|
94.5 mg/dL
STANDARD_DEVIATION 11.6 • n=206 Participants
|
93.7 mg/dL
STANDARD_DEVIATION 9.9 • n=7 Participants
|
|
Insulin
|
13.6 ulU/mL
STANDARD_DEVIATION 8.0 • n=99 Participants
|
15.4 ulU/mL
STANDARD_DEVIATION 9.3 • n=107 Participants
|
16.4 ulU/mL
STANDARD_DEVIATION 8.2 • n=206 Participants
|
15.1 ulU/mL
STANDARD_DEVIATION 8.4 • n=7 Participants
|
|
Total cholesterol
|
185.6 mg/dL
STANDARD_DEVIATION 26.7 • n=99 Participants
|
177.3 mg/dL
STANDARD_DEVIATION 40.5 • n=107 Participants
|
166.4 mg/dL
STANDARD_DEVIATION 33.2 • n=206 Participants
|
176.4 mg/dL
STANDARD_DEVIATION 33.8 • n=7 Participants
|
|
Low density lipoprotein
|
111.3 mg/dL
STANDARD_DEVIATION 27.5 • n=99 Participants
|
107.3 mg/dL
STANDARD_DEVIATION 40.5 • n=107 Participants
|
98.4 mg/dL
STANDARD_DEVIATION 28.8 • n=206 Participants
|
105.6 mg/dL
STANDARD_DEVIATION 32.1 • n=7 Participants
|
|
High density lipoprotein
|
54.7 mg/dL
STANDARD_DEVIATION 15.6 • n=99 Participants
|
53.9 mg/dL
STANDARD_DEVIATION 13.6 • n=107 Participants
|
48.3 mg/dL
STANDARD_DEVIATION 14.3 • n=206 Participants
|
52.2 mg/dL
STANDARD_DEVIATION 14.6 • n=7 Participants
|
|
Triglycerides
|
97.7 mg/dL
STANDARD_DEVIATION 46.1 • n=99 Participants
|
80.0 mg/dL
STANDARD_DEVIATION 23.2 • n=107 Participants
|
98.1 mg/dL
STANDARD_DEVIATION 40.2 • n=206 Participants
|
92.6 mg/dL
STANDARD_DEVIATION 38.6 • n=7 Participants
|
|
C-reactive protein
|
5.5 mg/L
STANDARD_DEVIATION 4.4 • n=99 Participants
|
5.6 mg/L
STANDARD_DEVIATION 4.9 • n=107 Participants
|
6.1 mg/L
STANDARD_DEVIATION 7.8 • n=206 Participants
|
5.7 mg/L
STANDARD_DEVIATION 5.9 • n=7 Participants
|
|
Pulse wave velocity
|
7.4 m/sec
STANDARD_DEVIATION 1.1 • n=99 Participants
|
6.9 m/sec
STANDARD_DEVIATION 1.3 • n=107 Participants
|
7.6 m/sec
STANDARD_DEVIATION 1.2 • n=206 Participants
|
7.3 m/sec
STANDARD_DEVIATION 1.2 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksFitness will be measured using a modified Balke protocol on a treadmill. Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes. The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion. Maximal oxygen consumption (Liters of O2 per minute) will be measured using a True Max 2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah).
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=13 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Cardiorespiratory Fitness
|
-0.15 Liters of oxygen/min
Interval -0.32 to 0.03
|
0.12 Liters of oxygen/min
Interval -0.07 to 0.31
|
0.22 Liters of oxygen/min
Interval 0.03 to 0.41
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksDual-energy X-ray absorptiometry will be used to measure changes in body fat percentage
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=13 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Body Fat Percentage
|
0.09 percentage of body fat
Interval -0.89 to 1.07
|
-0.26 percentage of body fat
Interval -1.35 to 0.83
|
-0.71 percentage of body fat
Interval -1.8 to 0.38
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksWeight will be measured using a calibrated scale. Weight will be measured in kg
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=13 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=14 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Body Weight
|
0.87 kg
Interval -1.04 to 2.8
|
-0.37 kg
Interval -2.45 to 1.7
|
-0.42 kg
Interval -2.52 to 1.67
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksWaist circumference will be measured at the natural waist (midway between the inferior border of the rib cage and the superior aspect of the iliac crest) with a Gulick tape measure. Both landmarks (the inferior border of the ribcage and the superior aspect of the iliac crest) will be marked and the distance will be measured to determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape remains horizontal; 2) the tape touches the entire circumference of the participant; 3) abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the measurement is taken at the end of normal respiration. The measurement will be repeated an additional time, and the reported value will be the average of these measurements. Both measurements must be within 0.5 cm to be considered acceptable for data purposes.
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=13 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Waist Circumference
|
-1.42 cm
Interval -3.9 to 1.0
|
0.41 cm
Interval -2.2 to 3.0
|
-1.3 cm
Interval -4.0 to 1.5
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksLow density lipoprotein will be measured from a fasting blood sample
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=12 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Low Density Lipoprotein
|
-7.1 mg/dL
Interval -15.2 to 1.1
|
-0.12 mg/dL
Interval -9.53 to 9.3
|
2.3 mg/dL
Interval -6.9 to 11.5
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksHigh density lipoprotein will be measured from a fasted blood sample
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=12 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in High Density Lipoprotein
|
-3.4 mg/dL
Interval -6.7 to -0.17
|
-1.1 mg/dL
Interval -4.9 to 2.7
|
1.3 mg/dL
Interval -2.3 to 5.0
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksTotal Cholesterol will be measured in a fasting blood sample
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=12 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Changes in Total Cholesterol
|
-10.4 mg/dL
Interval -20.5 to -0.21
|
-0.21 mg/dL
Interval -12.3 to 11.8
|
-0.71 mg/dL
Interval -12.5 to 11.1
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksTriglyceride levels will be measured from a fasting blood sample
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=12 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Triglycerides
|
-10.9 mg/dL
Interval -22.4 to 0.58
|
4.0 mg/dL
Interval -9.5 to 17.6
|
-13.3 mg/dL
Interval -26.1 to -0.45
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksHigh sensitivity c-reactive protein will be measured at baseline and follow-up
Outcome measures
| Measure |
Control (CON)
n=14 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=11 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Systemic Inflammation
|
0.142 mg/L
Interval -3.11 to 3.39
|
0.159 mg/L
Interval -3.54 to 3.84
|
0.31 mg/L
Interval -3.09 to 3.73
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksFasting glucose will be measured from a fasting blood sample
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=12 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Fasting Glucose
|
-2.81 mg/dL
Interval -6.7 to 1.1
|
-2.5 mg/dL
Interval -6.6 to 2.5
|
-2.0 mg/dL
Interval -6.3 to 2.4
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksFasting insulin value will be measured from a blood sample
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=12 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Insulin
|
-2.68 ulU/mL
Interval -6.4 to 1.0
|
-2.69 ulU/mL
Interval -6.9 to 1.6
|
-2.7 ulU/mL
Interval -6.8 to 1.4
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksInsulin sensitivity will be measured using an intravenous glucose tolerance test
Outcome measures
| Measure |
Control (CON)
n=11 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=6 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=7 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Insulin Sensitivity
|
0.60 (mu/l)^-1.min^-1
Interval -0.53 to 1.74
|
0.59 (mu/l)^-1.min^-1
Interval -0.94 to 2.12
|
0.44 (mu/l)^-1.min^-1
Interval -1.02 to 1.83
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksArterial stiffness will be measured using pulse wave velocity.
Outcome measures
| Measure |
Control (CON)
n=13 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=11 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=12 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Arterial Stiffness
|
-0.21 m/sec
Interval -0.76 to 0.34
|
0.68 m/sec
Interval 0.08 to 1.28
|
0.47 m/sec
Interval -0.11 to 1.04
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksMitochondrial enzymes (citrate synthase, pgc1aplha and complex1-5)
Outcome measures
| Measure |
Control (CON)
n=9 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=9 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=9 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Mitochondrial Enzymes
Complex 4
|
-0.32 U/mU
Interval -0.8 to 0.58
|
0.23 U/mU
Interval -0.22 to 0.67
|
0.01 U/mU
Interval -0.41 to 0.43
|
|
Change in Mitochondrial Enzymes
Complex 5
|
-0.05 U/mU
Interval -0.19 to 0.1
|
0.01 U/mU
Interval -0.07 to 0.27
|
0.01 U/mU
Interval -0.14 to 0.16
|
|
Change in Mitochondrial Enzymes
PGC1 alpha
|
-0.17 U/mU
Interval -0.45 to 0.09
|
0.02 U/mU
Interval -0.26 to 0.3
|
-0.02 U/mU
Interval -0.1 to 0.3
|
|
Change in Mitochondrial Enzymes
Citrate synthase
|
-0.01 U/mU
Interval -0.18 to 0.16
|
0.02 U/mU
Interval -0.14 to 0.18
|
0.17 U/mU
Interval 0.0 to 0.34
|
|
Change in Mitochondrial Enzymes
Complex 1
|
-0.36 U/mU
Interval -0.96 to 0.24
|
0.17 U/mU
Interval -0.43 to 0.77
|
-0.05 U/mU
Interval -0.65 to 0.56
|
|
Change in Mitochondrial Enzymes
Complex 2
|
-0.06 U/mU
Interval -0.49 to 0.36
|
0.16 U/mU
Interval -0.3 to 0.61
|
-0.05 U/mU
Interval -0.48 to 0.38
|
|
Change in Mitochondrial Enzymes
Complex 3
|
0.07 U/mU
Interval -0.19 to 0.34
|
0.09 U/mU
Interval -0.19 to 0.37
|
-0.01 U/mU
Interval -0.26 to 0.24
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksQuality of life (QOL) will be measured by the short form health survey (SF-36). SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status).
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=13 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Quality of Life
General Health
|
-1.6 score on a scale
Interval -4.0 to 0.8
|
1.3 score on a scale
Interval -1.4 to 3.9
|
-1.0 score on a scale
Interval -3.7 to 1.62
|
|
Change in Quality of Life
Physical health
|
-0.18 score on a scale
Interval -3.5 to 3.1
|
0.57 score on a scale
Interval -3.1 to 4.2
|
2.4 score on a scale
Interval -1.2 to 6.1
|
|
Change in Quality of Life
Role Physical
|
-0.22 score on a scale
Interval -3.2 to 2.8
|
-1.2 score on a scale
Interval -4.5 to 2.2
|
1.1 score on a scale
Interval -2.2 to 4.4
|
|
Change in Quality of Life
Bodily pain
|
-3.6 score on a scale
Interval -8.1 to 0.9
|
-2.1 score on a scale
Interval -7.0 to 2.9
|
0.2 score on a scale
Interval -4.8 to 5.3
|
|
Change in Quality of Life
Vitality
|
1.1 score on a scale
Interval -1.7 to 3.9
|
-1.51 score on a scale
Interval -4.5 to 1.5
|
2.6 score on a scale
Interval -0.4 to 5.7
|
|
Change in Quality of Life
Social Function
|
-0.15 score on a scale
Interval -3.6 to 3.3
|
-5.2 score on a scale
Interval -9.0 to -1.3
|
0.7 score on a scale
Interval -3.2 to 4.6
|
|
Change in Quality of Life
Mental health
|
0.8 score on a scale
Interval -1.6 to 3.1
|
-2.2 score on a scale
Interval -4.8 to 0.4
|
0.65 score on a scale
Interval -1.9 to 3.3
|
|
Change in Quality of Life
Role Emotional
|
0.8 score on a scale
Interval -1.5 to 3.1
|
-0.0 score on a scale
Interval -2.5 to 2.5
|
2.3 score on a scale
Interval -0.2 to 4.9
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksThe SF-36 also produces a measure of overall physical health (physical component score \[PCS\]) and overall mental health (mental component score \[MCS\]). Scoring of these items are standardized using means and standard deviations from the general US population. Aggregate PCS and MCS scores are standardized using a linear T-Score transformation to have a mean of 50 and a standard deviation of 10. A higher score indicates better quality of life and a lower score indicates worsened quality of life.
Outcome measures
| Measure |
Control (CON)
n=16 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=13 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=13 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Change in Quality of Life (Mental Health and Physical Health Summary Scores)
Physical health (sum)
|
-2.02 score on a scale
Interval -4.6 to 0.6
|
0.02 score on a scale
Interval -2.8 to 2.9
|
-0.11 score on a scale
Interval -3.0 to 2.8
|
|
Change in Quality of Life (Mental Health and Physical Health Summary Scores)
Mental health (sum)
|
0.75 score on a scale
Interval -1.7 to 3.3
|
-2.7 score on a scale
Interval -5.4 to 0.09
|
1.6 score on a scale
Interval -1.2 to 4.4
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksParticipants will wear an ActivPal accelerometer for seven consecutive days, 24-hrs/day. The change in steps will be be evaluated from baseline to 24 weeks
Outcome measures
| Measure |
Control (CON)
n=10 Participants
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Exercise (MOD-INT)
n=9 Participants
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Exercise HIGH-INT
n=9 Participants
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Changes in Physical Activity Levels
|
604.2 steps per day
Interval -792.9 to 2001.3
|
2311.0 steps per day
Interval 817.9 to 3804.1
|
2242.3 steps per day
Interval 763.3 to 3721.4
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Error in processing the data and it was lost
Food Frequency Questionnaire (FFQ) contains approximately 105 items grouped by categories and is completed for both frequency of consumption as well as portion size selections by the individual. The questionnaire, upon completion, provides estimated daily intake values for selected nutrients (kilocalories, macronutrients, and micronutrients) and provides information on food group servings.
Outcome measures
Outcome data not reported
Adverse Events
Control (CON)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Intensity Training (MOD-INT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High Intensity Training (HIGH-INT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control (CON)
n=18 participants at risk
This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete
|
Moderate Intensity Training (MOD-INT)
n=16 participants at risk
The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks
Moderate intensity exercise training (MOD-INT): Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
|
High Intensity Training (HIGH-INT)
n=18 participants at risk
High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks
High Intensity exercise training (HI-INT): Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
|
|---|---|---|---|
|
Cardiac disorders
Elevated blood pressure
|
0.00%
0/18 • 24 weeks per participants
|
6.2%
1/16 • Number of events 1 • 24 weeks per participants
|
0.00%
0/18 • 24 weeks per participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place