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=5 Participants	130 Participants n=7 Participants	272 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	71 Participants n=7 Participants	125 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	59 Participants n=7 Participants	147 Participants n=5 Participants
Region of Enrollment United States	142 participants n=5 Participants	130 participants n=7 Participants	272 participants n=5 Participants
Grade level	3.1 grade STANDARD_DEVIATION 1.4 • n=5 Participants	2.9 grade STANDARD_DEVIATION 1.4 • n=7 Participants	3.0 grade STANDARD_DEVIATION 1.4 • n=5 Participants
75 foot laps completed	13.5 laps completed STANDARD_DEVIATION 1.9 • n=5 Participants	13 laps completed STANDARD_DEVIATION 2 • n=7 Participants	13.3 laps completed STANDARD_DEVIATION 2 • n=5 Participants
After exercise- heart rate	163 beats per minute STANDARD_DEVIATION 27.9 • n=5 Participants	164.8 beats per minute STANDARD_DEVIATION 23.8 • n=7 Participants	163.9 beats per minute STANDARD_DEVIATION 25.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks later

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.

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 later

Immediate 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

Rebecca Hayes, M.D.

Marshall University

Phone: 3046173570

Email: hayes79@live.marshall.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place