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Comparative Effectiveness of Social Physical Play and Traditional Exercise Programming

Comparative Effectiveness of Social Physical Play and Traditional Exercise Programming

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03913078
Acronym
PlayFit
Enrollment
431
Registered
2019-04-12
Start date
2019-05-29
Completion date
2022-10-31
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group Fitness (Game Play-based), Group Fitness (Traditional)

Keywords

fitness, exercise, physical activity

Brief summary

This study will compare the impact of traditional group fitness versus a game-based fitness program, designed to maximize enjoyment, on physical fitness.

Detailed description

Fewer than 1 in 10 middle-aged US adults get the recommended amount of aerobic physical activity (PA), greatly increasing their chances of heart disease and stroke. There are over 50 million adults with fitness center memberships, which are used only once per month and, after joining new programs, people quickly stop coming. While many barriers to PA have been cited (e.g., time, cost), the investigators believe that a key, modifiable, and underappreciated barrier is that most adults simply do not enjoy physical activity enough to do it regularly. Studies consistently observe that people who enjoy physical activity more are more likely to be more active in the future. Despite this consistent observation, the investigators are not aware of studies that ask Would an adult PA program designed to maximize enjoyment increase PA adherence and fitness?. In 2015, our team set out to design an exercise program for adults that maximized enjoyment. Taking inspiration from Pickleball, a popular game of modified tennis, our team created PlayFit. PlayFit is an exercise program in which adults come together three times each week to play a range of sports, all modified to 1) reduce effort (e.g., smaller playing area), 2) reduce injuries (e.g., lightweight low-pressure balls) and 3) reduce competitiveness (e.g., teams chosen randomly, minimize physical contact, no keeping score). Pilot work in the summer of 2016 with 22 adults identified five modified sports that all had Metabolic Equivalent (MET) levels between 5.5 and 6.5 and high satisfaction scores (average of 8.0 out of 10). More importantly, the comments suggest that the investigators have created a social, enjoyable experience: that was SO much fun, I've never had so much fun playing soccer. People liked the laughter during the games, no pressure, not competitive and that it's not about ability, it's just about having fun with people. In this study, the investigators initially proposed testing whether PlayFit would lead to greater fitness gains, compared to group fitness, to help providers understand in a way that helps providers and fitness center staff understand: What exercise program should I recommend to promote long-term adherence and fitness?. All subjects were to be expected to exercise three-times weekly for 60 minutes for 12 months. The investigators planned to randomly assign 360 adults to two conditions: 1) Group Fitness activities and 2) PlayFit. The investigators hypothesized that both PlayFit and Group Fitness would increase Maximum Oxygen Uptake (V02max) significantly at 6 months but, after 12 months, mediated by greater enjoyment and higher adherence, participants randomized to PlayFit would have greater fitness and activity gains at 12 months than Group Fitness. The results of this study would have the potential to help patients, providers and fitness center directors by answering the question: What exercise program should be recommended to sedentary adults in order to promote long-term adherence and fitness? Although we originally intended for data collection to conclude by 2021, human-subjects research was largely prohibited throughout 2020 due to the SARS-CoV-2 pandemic. Near the end of 2020 we began to conduct outdoor-only activities. Indoor human-subjects research continued to be restricted throughout 2020 and early 2021. Once large-scale research restrictions were lifted, recruitment and baseline testing resumed in May 2021, with the first new cohorts beginning in their respective sessions in August 2021. Unfortunately, all human-subjects research was again prohibited for approximately 45 days during January and February 2022. For several reasons, including the likely deconditioning of participants during the pause, that several participants responded that they were unwilling or fearful to return given the perceived health risks, and that some community partners were no longer willing to host the PA sessions during the pandemic, we concluded that our best course of action was to analyze data up to the most recent measurement timepoint preceding this 45-day mandated pause in data collection (month 3). This decision meant that we were unable to test our original hypotheses. For example, only baseline cardiorespiratory fitness and accelerometry data were available, as the second time point to collect these data was to occur at month 6. However, analyses for group session adherence were possible, as these data were collected continuously throughout the study.

Interventions

BEHAVIORALGroup Fitness

Traditional Group Fitness consisting of aerobic and strength exercises performed in a group setting and led by a trained instructor.

BEHAVIORALPlayFit

Modified sports fitness exercise program consisting of games played in groups and led by a trained instructor.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Participants are aware of the two different exercise conditions and accept randomization into either of the two. The investigator and outcomes assessor are masked, but participant is aware of group assignment.

Intervention model description

Increases in perceived enjoyment lead to increases in physical activity adherence which lead to increases in physical fitness

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 18+ * Sedentary (\<90 minutes of self-reported moderate-vigorous activity each week) * Health care provider must give permission.

Exclusion criteria

* History of heart disease, stroke or chest pain. * Participating in another research study involving physical activity or weight loss. * Planning to have surgery or move in the next year.

Design outcomes

Primary

MeasureTime frameDescription
Session AttendanceDuration of participation in study, up to 1 yearAdherence to the intervention sessions was collected by the PlayFit and Group Fitness group leaders during each session using a REDCap attendance survey.

Countries

United States

Participant flow

Pre-assignment details

26 participants consented to participate in the study, but did not complete baseline measures, and were therefore not allocated to a study arm.

Participants by arm

ArmCount
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.
200
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.
205
Total405

Baseline characteristics

CharacteristicTotalPlayFitGroup Fitness
Age, Continuous39.5 years
STANDARD_DEVIATION 7.4
39.7 years
STANDARD_DEVIATION 7.6
39.4 years
STANDARD_DEVIATION 7.2
Body Mass Index33.0 kg/m^2
STANDARD_DEVIATION 10
33.1 kg/m^2
STANDARD_DEVIATION 10
33.0 kg/m^2
STANDARD_DEVIATION 10.1
Ethnicity (NIH/OMB)
Hispanic or Latino
23 Participants10 Participants13 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
356 Participants182 Participants174 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
26 Participants13 Participants13 Participants
MVPA166.1 minutes per week
STANDARD_DEVIATION 89.7
168.1 minutes per week
STANDARD_DEVIATION 88
164.1 minutes per week
STANDARD_DEVIATION 92
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
31 Participants20 Participants11 Participants
Race (NIH/OMB)
Black or African American
31 Participants12 Participants19 Participants
Race (NIH/OMB)
More than one race
16 Participants9 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
34 Participants17 Participants17 Participants
Race (NIH/OMB)
White
290 Participants146 Participants144 Participants
Region of Enrollment
United States
405 participants205 participants200 participants
Sex: Female, Male
Female
292 Participants146 Participants146 Participants
Sex: Female, Male
Male
113 Participants59 Participants54 Participants
VO2 Maximum24.4 ml/kg/min
STANDARD_DEVIATION 7.4
25.1 ml/kg/min
STANDARD_DEVIATION 9
23.7 ml/kg/min
STANDARD_DEVIATION 5.1

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2000 / 205
other
Total, other adverse events
19 / 20038 / 205
serious
Total, serious adverse events
0 / 2000 / 205

Outcome results

Primary

Session Attendance

Adherence to the intervention sessions was collected by the PlayFit and Group Fitness group leaders during each session using a REDCap attendance survey.

Time frame: Duration of participation in study, up to 1 year

Population: All participants that were assigned to an arm are included in this analysis, even if they never attended a session

ArmMeasureValue (MEAN)Dispersion
Group FitnessSession Attendance12.3 Percentage of possible sessions attendedStandard Deviation 15.5
PlayFitSession Attendance10.4 Percentage of possible sessions attendedStandard Deviation 13
Post Hoc

Total Possible Sessions

This is the total number of sessions that each participant was potentially able to attend.

Time frame: Duration of participation in study, up to 1 year

ArmMeasureValue (MEAN)Dispersion
Group FitnessTotal Possible Sessions104.3 Possible sessionsStandard Deviation 49.7
PlayFitTotal Possible Sessions110.0 Possible sessionsStandard Deviation 55.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026