Physical Activity and Social Engagement for Persons With Disabilities in an Underserved Community

Study Overview
=================
Brief Summary
-----------------
Using a community-based participatory approach, this project aims to evaluate the feasibility, acceptability, and preliminary efficacy of two technology-driven group activity programs on socioemotional health and physical activity in a local underserved community, Tarrant, Alabama. Participants will complete two six-week programs, specifically Lakeshore Online Fitness (Online) and Get Active with Virtual Reality (VR).

Detailed Description
-----------------
This project will utilize a cross-over randomized design where participants will initially be randomized into either the Online or VR intervention group. After completing the initial six weeks of the assigned intervention, participants will cross over and complete six weeks of the other intervention. No washout period is included due to several reasons, including no known washout period for certain socioemotional outcomes have been established by prior literature, ethical concerns in requiring return to baseline levels during washout, and a prolonged washout period would negatively impact participant adherence and retention to the study. Psychosocial metrics will be collected at the end of each activity session through surveys.

Official Title
-----------------
Physical Activity and Social Engagement Program for Persons With Disabilities and Chronic Health Conditions in an Underserved Birmingham Community

Conditions
-----------------
Disability Physical, Chronic Conditions, Multiple, Aging

Intervention / Treatment
-----------------
* Behavioral: Lakeshore Online Fitness (Online)
* Behavioral: Get Active with Virtual Reality (VR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident of Tarrant, Alabama 18 years or older with a physical disability or chronic health condition or older than 60 years Fluent in English Exclusion Criteria: Visual impairment that interferes with television viewing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tarrant Community Fitness Program: LOF-VR<br>LOF-VR | Behavioral: Lakeshore Online Fitness (Online)<br>* Online physical activity program delivered to residents of Tarrant, AL via teleconferencing technology to a local community center. Instructors from Lakeshore will lead the physical activity program. This intervention will last six weeks.<br>Behavioral: Get Active with Virtual Reality (VR)<br>* Participants will utilize the Oculus Quest 2 virtual reality headset, which is a head-mounted display system where users can interact with a virtual environment in a gaming setting. The Oculus Quest 2 incorporates social features where participants can interact with other users. This VR intervention will include periods of gameplay where participants can play games in either competitive or cooperative settings. This intervention will last six weeks.<br>|
| Experimental: Tarrant Community Fitness Program: VR-LOF<br>VR-LOF | Behavioral: Lakeshore Online Fitness (Online)<br>* Online physical activity program delivered to residents of Tarrant, AL via teleconferencing technology to a local community center. Instructors from Lakeshore will lead the physical activity program. This intervention will last six weeks.<br>Behavioral: Get Active with Virtual Reality (VR)<br>* Participants will utilize the Oculus Quest 2 virtual reality headset, which is a head-mounted display system where users can interact with a virtual environment in a gaming setting. The Oculus Quest 2 incorporates social features where participants can interact with other users. This VR intervention will include periods of gameplay where participants can play games in either competitive or cooperative settings. This intervention will last six weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Social Isolation from Baseline to 12 weeks | PROMIS Item Bank v2.0 - Social Isolation - SF 8a | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-efficacy from Baseline to 12 weeks | Self-efficacy for Exercise (SEE) Scale | 12 Weeks | 
| Change in Loneliness from Baseline to 12 weeks | NIH Toolbox Item Bank v2.0-Loneliness (Ages 18+)-Fixed Form | 12 Weeks | 
| Change in Positive Affect from Baseline to 12 weeks | NIH Toolbox Item Bank v2.0-Positive Affect | 12 Weeks | 
| Change in Health-related quality of life from Baseline to 12 weeks | SF-36v2 | 12 Weeks | 
| Change in Physical activity from Baseline to 12 weeks | Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) | 12 Weeks | 
| Change in Enjoyment from Baseline to 12 weeks | Visual Analog Scale (VAS) & Modified Physical Activity Enjoyment Scale (PACES) | 12 Weeks | 
| Change in Physical Function from Baseline to 12 weeks | Physical Function - Short Form 20a | 12 Weeks |