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| ID | Type | Description | Link |
|---|---|---|---|
| R33HL142679 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study will compare the impact of traditional group fitness versus a game-based fitness program, designed to maximize enjoyment, on physical fitness.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Fitness | Active Comparator | Subjects will be offered several sessions per week of a traditional group fitness program led by a trained group leader. |
|
| PlayFit | Active Comparator | Subjects will be offered several sessions per week of a modified sports fitness program, led by a trained group leader. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Fitness | Behavioral | Traditional Group Fitness consisting of aerobic and strength exercises performed in a group setting and led by a trained instructor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Duration of participation in study, up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Sciamanna, MD, MPH | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
Final, clean, data filed will be uploaded to a publicly available site (e.g., ISPSR), within 12 months of finishing study.
Within 12 months of completing the final follow-up visit on the last study subject.
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26 participants consented to participate in the study, but did not complete baseline measures, and were therefore not allocated to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants that were assigned to an arm are included in this analysis, even if they never attended a session | Posted | Mean | Standard Deviation | Percentage of possible sessions attended | Duration of participation in study, up to 1 year |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Human-subjects research was largely prohibited throughout 2020 and early 2021 due to the SARS-CoV-2 pandemic. Large-scale research restrictions were lifted in May 2021. All human-subjects research was again prohibited during January and February 2022. After that pause, participants were unwilling to return given the perceived health risks and community partners were no longer willing to host the PA sessions during the pandemic. Full participation in the trial as planned was then not possible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Sciamanna, MD, MPH | Milton S. Hershey Medical Center | 717-531-4417 | csciamanna@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2024 | Apr 9, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2023 | Apr 9, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Increases in perceived enjoyment lead to increases in physical activity adherence which lead to increases in physical fitness
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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.
| PlayFit | Behavioral | Modified sports fitness exercise program consisting of games played in groups 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | All participants contributing data were included in this analysis. | Mean | Standard Deviation | kg/m^2 |
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| VO2 Maximum | As indoor activities were restricted by the SARS-CoV-2 pandemic, some participants were unable to complete VO2 maximum testing. | Mean | Standard Deviation | ml/kg/min |
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| MVPA | Moderate-to-vigorous physical activity, measured via accelerometry in minutes per week | The ability to distribute accelerometers was limited by the SARS-CoV-2 pandemic. | Mean | Standard Deviation | minutes per week |
|
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. |
|
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| Post-Hoc | Total Possible Sessions | This is the total number of sessions that each participant was potentially able to attend. | Posted | Mean | Standard Deviation | Possible sessions | Duration of participation in study, up to 1 year |
|
|
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| 0 |
| 200 |
| 0 |
| 200 |
| 19 |
| 200 |
| EG001 | 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. | 0 | 205 | 0 | 205 | 38 | 205 |
| Seizure | Nervous system disorders | Systematic Assessment |
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| Migraine | Nervous system disorders | Systematic Assessment |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|