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Comparative Effectiveness of Social Physical Play and Traditional Exercise Programming (PlayFit)

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ClinicalTrials.gov Identifier: NCT03913078
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Group Fitness (Traditional) Group Fitness (Game Play-based) Behavioral: Group Fitness Behavioral: PlayFit Phase 3

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 propose testing whether PlayFit leads 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 will be expected to exercise three-times weekly for 60 minutes for 12 months. The investigators will randomly assign 360adults to two conditions: 1) Group Fitness activities and 2) PlayFit. The investigators hypothesize that both PlayFit and Group Fitness will increase Maximum Oxygen Uptake (V02max) significantly at 6 months but, after 12 months, mediated by greater enjoyment and higher adherence, participants randomized to PlayFit will have greater fitness and activity gains at 12 months than Group Fitness. The results of this study 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?"

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Increases in perceived enjoyment lead to increases in physical activity adherence which lead to increases in physical fitness
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.
Primary Purpose: Prevention
Official Title: Comparative Effectiveness of Social Physical Play and Traditional Exercise Programming
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group Fitness
Subjects will be offered several sessions per week of a traditional group fitness program led by a trained group leader.
Behavioral: Group Fitness
Traditional Group Fitness consisting of aerobic and strength exercises performed in a group setting and led by a trained instructor.

Active Comparator: PlayFit
Subjects will be offered several sessions per week of a modified sports fitness program, led by a trained group leader.
Behavioral: PlayFit
Modified sports fitness exercise program consisting of games played in groups and led by a trained instructor.




Primary Outcome Measures :
  1. Maximum Oxygen Uptake (V02Max) [ Time Frame: 12 months ]
    Maximum Oxygen Uptake (V02Max), a measure of aerobic Fitness, will be assessed using a maximal graded treadmill test, using a Bruce protocol and heart rate and expired gas monitoring (74). V02Max is calculated based on the millilitres of oxygen consumed per kilogram of body mass per minute (e.g., mL/(kg·min)).


Secondary Outcome Measures :
  1. Minutes of Moderate-Vigorous Physical Activity (MVPA) [ Time Frame: 12 months ]
    Minutes of Moderate-Vigorous Physical Activity (MVPA) will be measured using an Actigraph GT3X tri-axial accelerometer, which can measure the intensity of PA and the frequency/pattern of activity over time.


Other Outcome Measures:
  1. Body weight [ Time Frame: 12 months ]
    Body weight in kilograms will be measured by a research assistant using a calibrated stadiometer.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913078


Contacts
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Contact: Christopher Sciamanna, MD, MPH 717-531-4417 csciamanna@pennstatehealth.psu.edu
Contact: Tami Cassel 717-531-8161 tcassel1@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Christopher Sciamanna, MD, MPH    717-531-8161    csciamanna@pennstatehealth.psu.edu   
Principal Investigator: Christopher Sciamanna, MD, MPH         
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Christopher Sciamanna, MD, MPH Milton S. Hershey Medical Center

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Responsible Party: Christopher Sciamanna, MD, MPH, Professor of Medicine and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03913078     History of Changes
Other Study ID Numbers: HL142679
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final, clean, data filed will be uploaded to a publicly available site (e.g., ISPSR), within 12 months of finishing study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Within 12 months of completing the final follow-up visit on the last study subject.
URL: https://www.icpsr.umich.edu/icpsrweb/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center:
fitness
exercise
physical activity