Comparative Effectiveness of Social Physical Play and Traditional Exercise Programming

NCT ID: NCT03913078

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 431 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-29
• Study Completion Date: 2022-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group Fitness

Subjects will be offered several sessions per week of a traditional group fitness program led by a trained group leader.

Group Type: ACTIVE_COMPARATOR

Group Fitness

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

PlayFit

Intervention Type: BEHAVIORAL

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

Interventions

Group Fitness

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

Intervention Type: BEHAVIORAL

PlayFit

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christopher Sciamanna, MD, MPH

Professor of Medicine and Public Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Sciamanna, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R33HL142679

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HL142679

Identifier Type: -

Identifier Source: org_study_id