An mHealth Exercise Intervention for Sedentary Adults

Study Overview
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Brief Summary
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This pilot trial examines the feasibility and acceptability of a web-based, social networking exercise intervention in improving physical activity behavior in adults who do not perform regular exercise.

Detailed Description
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Primary Objective To determine the feasibility and acceptability of an 8-week remotely-delivered exercise intervention by conducting a randomized controlled study comparing 3 levels of behavioral engagement. Secondary Objectives To compare the effectiveness of 3 levels of web-based interaction on physical activity behavior, physiological training dose, motivation and quality of life. Participants are randomly assigned to 1 of 3 groups: Level 1 (attention control): Participants receive health educational materials through email and the web portal. Level 2 (videos): Participants receive health education materials + access to 24 pre-recorded exercise videos. Level 3 (livestream classes): Participant receive health education materials + livestream exercise classes 3 days/week for 8 weeks.

Official Title
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A Remotely Delivered, Web-Based Exercise Intervention for Sedentary Adults: Randomized Controlled Pilot Trial

Conditions
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Exercise Behavior

Intervention / Treatment
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* Behavioral: Wellness Education
* Behavioral: Exercise Videos
* Behavioral: Livestream Classes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not exceeding 60 total minutes of physical activity per week Access to computer or mobile device with high speed internet connection Exclusion Criteria: History of myocardial infarction, angioplasty, coronary artery bypass, cerebrovascular ischemia/stroke, symptomatic congestive heart failure, atrial flutter, unstable angina, or unstable pulmonary disease; pacemaker; history of alcoholism, drug abuse or other psychiatric problems; current use of tricyclic antidepressant or clozapine medications; type 1 diabetes; orthopedic or rheumatologic problems that could impair the ability to walk.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Level 1<br>Wellness Education | Behavioral: Wellness Education<br>* Receive wellness education through a weekly email and web portal content.<br>|
| Experimental: Level 2<br>Wellness Education + Pre-recorded Exercise Videos | Behavioral: Wellness Education<br>* Receive wellness education through a weekly email and web portal content.<br>Behavioral: Exercise Videos<br>* Receive pre-recorded exercise videos through a weekly email and web portal content.<br>|
| Experimental: Level 3<br>Wellness Education + Livestream Exercise Classes | Behavioral: Wellness Education<br>* Receive wellness education through a weekly email and web portal content.<br>Behavioral: Livestream Classes<br>* Receive 3 videoconference group exercise classes per week for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual | Measured as the percentage of the eligible target sample enrolled within a 1-year recruitment period. | Up to 1 year | 
| Retention | Measured as the percentage of participants completing post-intervention assessments | Up to 1 month | 
| Adherence | Measured as the number sessions completed using activity tracker | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate to Vigorous Physical Activity | Amount of time per week spent performing activity >63% maximum heart rate | Up to 2 months | 
| Resting Heart Rate | Average heart rate over a 10 minute period taken while sitting at rest | Baseline, 2 months | 
| International Physical Activity Questionnaire (IPAQ) | IPAQ estimates weekly moderate to vigorous intensity physical activity | Baseline, 2 months | 
| Short Form-36 (SF-36) | A 36-item survey that assesses general quality of life status | Baseline, 2 months | 
| Profile of Mood States (POMS) | A 65-item survey that assesses the participant's mood | Baseline, 2 months | 
| Physical Activity Group Questionnaire | A 21-item survey that assesses individual and group perceptions of task and social cohesion | Baseline, 2 months |