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
|Condition or disease||Intervention/treatment||Phase|
|Group Fitness (Traditional) Group Fitness (Game Play-based)||Behavioral: Group Fitness Behavioral: PlayFit||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|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.|
|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|
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.
Modified sports fitness exercise program consisting of games played in groups and led by a trained instructor.
- 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)).
- 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.
- Body weight [ Time Frame: 12 months ]Body weight in kilograms will be measured by a research assistant using a calibrated stadiometer.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913078
|Contact: Christopher Sciamanna, MD, MPHemail@example.com|
|Contact: Tami Casselfirstname.lastname@example.org|
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Christopher Sciamanna, MD, MPH 717-531-8161 email@example.com|
|Principal Investigator: Christopher Sciamanna, MD, MPH|
|Principal Investigator:||Christopher Sciamanna, MD, MPH||Milton S. Hershey Medical Center|