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Group Fitness (Traditional)PlayFitNCT03913078

Comparative Effectiveness of Social Physical Play and Traditional Exercise Programming

A study testing Group Fitness and PlayFit in people with Group Fitness (Traditional) and Group Fitness (Game Play-based), run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Group Fitness and PlayFit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
431 participants
Where
1 siteUnited States
Study dates
29 May 2019to 31 Oct 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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

Read the 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.

Being tested
Group Fitness, PlayFit
Keywords
fitness, exercise, physical activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group FitnessBehavioural

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

  • PlayFitBehavioural

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

Study groups in NCT03913078
Study groupRoleWhat they receive
Group FitnessActive comparatorSubjects will be offered several sessions per week of a traditional group fitness program led by a trained group leader.
Receives: Behavioral: Group Fitness
PlayFitActive comparatorSubjects will be offered several sessions per week of a modified sports fitness program, led by a trained group leader.
Receives: Behavioral: PlayFit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Duration of participation in study, up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2019
  2. Study start29 May 2019
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Increases in perceived enjoyment lead to increases in physical activity adherence which lead to increases in physical fitness
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
431 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03913078
Sponsor's protocol ID
HL142679
Other IDs
R33HL142679
Acronym
PlayFit
Status last verified
May 2024
First submitted
9 Apr 2019
Last updated
4 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Final, clean, data filed will be uploaded to a publicly available site (e.g., ISPSR), within 12 months of finishing study.

Questions about this trial

What is this clinical trial studying?

A study testing Group Fitness and PlayFit in people with Group Fitness (Traditional) and Group Fitness (Game Play-based), run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Session Attendance (time frame: Duration of participation in study, up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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