Trial Outcomes & Findings for Comparative Effectiveness of Social Physical Play and Traditional Exercise Programming (NCT NCT03913078)
NCT ID: NCT03913078
Last Updated: 2024-06-04
Results Overview
Adherence to the intervention sessions was collected by the PlayFit and Group Fitness group leaders during each session using a REDCap attendance survey.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
431 participants
Primary outcome timeframe
Duration of participation in study, up to 1 year
Results posted on
2024-06-04
Participant Flow
26 participants consented to participate in the study, but did not complete baseline measures, and were therefore not allocated to a study arm.
Participant milestones
| Measure |
Group Fitness
Subjects will be offered several sessions per week of a traditional group fitness program led by a trained group leader.
Group Fitness: Traditional Group Fitness consisting of aerobic and strength exercises performed in a group setting and led by a trained instructor.
|
PlayFit
Subjects will be offered several sessions per week of a modified sports fitness program, led by a trained group leader.
PlayFit: Modified sports fitness exercise program consisting of games played in groups and led by a trained instructor.
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
205
|
|
Overall Study
COMPLETED
|
200
|
205
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All participants contributing data were included in this analysis.
Baseline characteristics by cohort
| Measure |
Group Fitness
n=200 Participants
Subjects will be offered several sessions per week of a traditional group fitness program led by a trained group leader.
Group Fitness: Traditional Group Fitness consisting of aerobic and strength exercises performed in a group setting and led by a trained instructor.
|
PlayFit
n=205 Participants
Subjects will be offered several sessions per week of a modified sports fitness program, led by a trained group leader.
PlayFit: Modified sports fitness exercise program consisting of games played in groups and led by a trained instructor.
|
Total
n=405 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 7.2 • n=200 Participants
|
39.7 years
STANDARD_DEVIATION 7.6 • n=205 Participants
|
39.5 years
STANDARD_DEVIATION 7.4 • n=405 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=200 Participants
|
146 Participants
n=205 Participants
|
292 Participants
n=405 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=200 Participants
|
59 Participants
n=205 Participants
|
113 Participants
n=405 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=200 Participants
|
10 Participants
n=205 Participants
|
23 Participants
n=405 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
174 Participants
n=200 Participants
|
182 Participants
n=205 Participants
|
356 Participants
n=405 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=200 Participants
|
13 Participants
n=205 Participants
|
26 Participants
n=405 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=200 Participants
|
1 Participants
n=205 Participants
|
3 Participants
n=405 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=200 Participants
|
20 Participants
n=205 Participants
|
31 Participants
n=405 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=200 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=405 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=200 Participants
|
12 Participants
n=205 Participants
|
31 Participants
n=405 Participants
|
|
Race (NIH/OMB)
White
|
144 Participants
n=200 Participants
|
146 Participants
n=205 Participants
|
290 Participants
n=405 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=200 Participants
|
9 Participants
n=205 Participants
|
16 Participants
n=405 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=200 Participants
|
17 Participants
n=205 Participants
|
34 Participants
n=405 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=200 Participants
|
205 participants
n=205 Participants
|
405 participants
n=405 Participants
|
|
Body Mass Index
|
33.0 kg/m^2
STANDARD_DEVIATION 10.1 • n=186 Participants • All participants contributing data were included in this analysis.
|
33.1 kg/m^2
STANDARD_DEVIATION 10.0 • n=181 Participants • All participants contributing data were included in this analysis.
|
33.0 kg/m^2
STANDARD_DEVIATION 10.0 • n=367 Participants • All participants contributing data were included in this analysis.
|
|
VO2 Maximum
|
23.7 ml/kg/min
STANDARD_DEVIATION 5.1 • n=49 Participants • As indoor activities were restricted by the SARS-CoV-2 pandemic, some participants were unable to complete VO2 maximum testing.
|
25.1 ml/kg/min
STANDARD_DEVIATION 9.0 • n=92 Participants • As indoor activities were restricted by the SARS-CoV-2 pandemic, some participants were unable to complete VO2 maximum testing.
|
24.4 ml/kg/min
STANDARD_DEVIATION 7.4 • n=141 Participants • As indoor activities were restricted by the SARS-CoV-2 pandemic, some participants were unable to complete VO2 maximum testing.
|
|
MVPA
|
164.1 minutes per week
STANDARD_DEVIATION 92.0 • n=82 Participants • The ability to distribute accelerometers was limited by the SARS-CoV-2 pandemic.
|
168.1 minutes per week
STANDARD_DEVIATION 88.0 • n=84 Participants • The ability to distribute accelerometers was limited by the SARS-CoV-2 pandemic.
|
166.1 minutes per week
STANDARD_DEVIATION 89.7 • n=166 Participants • The ability to distribute accelerometers was limited by the SARS-CoV-2 pandemic.
|
PRIMARY outcome
Timeframe: Duration of participation in study, up to 1 yearPopulation: All participants that were assigned to an arm are included in this analysis, even if they never attended a session
Adherence to the intervention sessions was collected by the PlayFit and Group Fitness group leaders during each session using a REDCap attendance survey.
Outcome measures
| Measure |
Group Fitness
n=200 Participants
Subjects will be offered several sessions per week of a traditional group fitness program led by a trained group leader.
Group Fitness: Traditional Group Fitness consisting of aerobic and strength exercises performed in a group setting and led by a trained instructor.
|
PlayFit
n=205 Participants
Subjects will be offered several sessions per week of a modified sports fitness program, led by a trained group leader.
PlayFit: Modified sports fitness exercise program consisting of games played in groups and led by a trained instructor.
|
|---|---|---|
|
Session Attendance
|
12.3 Percentage of possible sessions attended
Standard Deviation 15.5
|
10.4 Percentage of possible sessions attended
Standard Deviation 13.0
|
POST_HOC outcome
Timeframe: Duration of participation in study, up to 1 yearThis is the total number of sessions that each participant was potentially able to attend.
Outcome measures
| Measure |
Group Fitness
n=200 Participants
Subjects will be offered several sessions per week of a traditional group fitness program led by a trained group leader.
Group Fitness: Traditional Group Fitness consisting of aerobic and strength exercises performed in a group setting and led by a trained instructor.
|
PlayFit
n=205 Participants
Subjects will be offered several sessions per week of a modified sports fitness program, led by a trained group leader.
PlayFit: Modified sports fitness exercise program consisting of games played in groups and led by a trained instructor.
|
|---|---|---|
|
Total Possible Sessions
|
104.3 Possible sessions
Standard Deviation 49.7
|
110.0 Possible sessions
Standard Deviation 55.9
|
Adverse Events
Group Fitness
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
PlayFit
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group Fitness
n=200 participants at risk
Subjects will be offered several sessions per week of a traditional group fitness program led by a trained group leader.
Group Fitness: Traditional Group Fitness consisting of aerobic and strength exercises performed in a group setting and led by a trained instructor.
|
PlayFit
n=205 participants at risk
Subjects will be offered several sessions per week of a modified sports fitness program, led by a trained group leader.
PlayFit: Modified sports fitness exercise program consisting of games played in groups and led by a trained instructor.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Injury
|
9.0%
18/200 • Number of events 23 • Adverse event data were collected monthly for the duration of participation in the study, up to 1 year. This time period varied by participant due to the impact of the SARS-CoV-2 pandemic.
Injuries and other adverse events were assessed monthly using a self-report questionnaire that consisted of 7-items focusing on injury location and severity.
|
18.0%
37/205 • Number of events 50 • Adverse event data were collected monthly for the duration of participation in the study, up to 1 year. This time period varied by participant due to the impact of the SARS-CoV-2 pandemic.
Injuries and other adverse events were assessed monthly using a self-report questionnaire that consisted of 7-items focusing on injury location and severity.
|
|
Nervous system disorders
Seizure
|
0.00%
0/200 • Adverse event data were collected monthly for the duration of participation in the study, up to 1 year. This time period varied by participant due to the impact of the SARS-CoV-2 pandemic.
Injuries and other adverse events were assessed monthly using a self-report questionnaire that consisted of 7-items focusing on injury location and severity.
|
0.49%
1/205 • Number of events 1 • Adverse event data were collected monthly for the duration of participation in the study, up to 1 year. This time period varied by participant due to the impact of the SARS-CoV-2 pandemic.
Injuries and other adverse events were assessed monthly using a self-report questionnaire that consisted of 7-items focusing on injury location and severity.
|
|
Nervous system disorders
Migraine
|
0.50%
1/200 • Number of events 1 • Adverse event data were collected monthly for the duration of participation in the study, up to 1 year. This time period varied by participant due to the impact of the SARS-CoV-2 pandemic.
Injuries and other adverse events were assessed monthly using a self-report questionnaire that consisted of 7-items focusing on injury location and severity.
|
0.00%
0/205 • Adverse event data were collected monthly for the duration of participation in the study, up to 1 year. This time period varied by participant due to the impact of the SARS-CoV-2 pandemic.
Injuries and other adverse events were assessed monthly using a self-report questionnaire that consisted of 7-items focusing on injury location and severity.
|
Additional Information
Christopher Sciamanna, MD, MPH
Milton S. Hershey Medical Center
Phone: 717-531-4417
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place