Trial Outcomes & Findings for Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children (NCT NCT02087774)
NCT ID: NCT02087774
Last Updated: 2014-08-15
Results Overview
Subjects run for 2 minutes around cone separated by 75ft. One lap was one 75 foot length completed. Difference in laps completed from baseline was taken.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
Baseline to 12 weeks later
Results posted on
2014-08-15
Participant Flow
Participant milestones
| Measure |
Control School
Control School received no intervention.
|
Intervention Group
Two schools participated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.
One intervention school implemented the program with responsibility given to the principal (school-wide group) and the other school asked the individual teachers to implement the program daily (classroom based group).
Physical Activity and Incentives
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
142
|
130
|
|
Overall Study
NOT COMPLETED
|
8
|
20
|
Reasons for withdrawal
| Measure |
Control School
Control School received no intervention.
|
Intervention Group
Two schools participated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.
One intervention school implemented the program with responsibility given to the principal (school-wide group) and the other school asked the individual teachers to implement the program daily (classroom based group).
Physical Activity and Incentives
|
|---|---|---|
|
Overall Study
Were absent day of data collection
|
8
|
20
|
Baseline Characteristics
Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children
Baseline characteristics by cohort
| Measure |
Control School
n=142 Participants
Control School received no intervention.
|
Intervention Group
n=130 Participants
Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.
The responsibility was given to the principal to implement the program.
Physical Activity and Incentives
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
142 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
272 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
142 participants
n=99 Participants
|
130 participants
n=107 Participants
|
272 participants
n=206 Participants
|
|
Grade level
|
3.1 grade
STANDARD_DEVIATION 1.4 • n=99 Participants
|
2.9 grade
STANDARD_DEVIATION 1.4 • n=107 Participants
|
3.0 grade
STANDARD_DEVIATION 1.4 • n=206 Participants
|
|
75 foot laps completed
|
13.5 laps completed
STANDARD_DEVIATION 1.9 • n=99 Participants
|
13 laps completed
STANDARD_DEVIATION 2 • n=107 Participants
|
13.3 laps completed
STANDARD_DEVIATION 2 • n=206 Participants
|
|
After exercise- heart rate
|
163 beats per minute
STANDARD_DEVIATION 27.9 • n=99 Participants
|
164.8 beats per minute
STANDARD_DEVIATION 23.8 • n=107 Participants
|
163.9 beats per minute
STANDARD_DEVIATION 25.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks laterSubjects run for 2 minutes around cone separated by 75ft. One lap was one 75 foot length completed. Difference in laps completed from baseline was taken.
Outcome measures
| Measure |
Control School
n=142 Participants
Control School received no intervention.
|
Intervention Group
n=130 Participants
Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.
The responsibility was given to the principal to implement the program.
Physical Activity and Incentives
|
|---|---|---|
|
Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes
|
-0.08 Difference in Laps Completed
95% Confidence Interval Referent • Interval -0.1 to -0.04
|
0.53 Difference in Laps Completed
Interval 0.17 to 1.1
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks laterImmediate cool-down, after-exercise heart rate was taken. Difference in heart rate from baseline measurements is reported
Outcome measures
| Measure |
Control School
n=142 Participants
Control School received no intervention.
|
Intervention Group
n=130 Participants
Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.
The responsibility was given to the principal to implement the program.
Physical Activity and Incentives
|
|---|---|---|
|
Change From Baseline to After Intervention for After-Exercise Heart Rate
|
16.0 beats per minute
Interval 10.5 to 20.3
|
-21.4 beats per minute
Interval -29.1 to -14.5
|
Adverse Events
Control School
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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