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

Not Applicable

Completed

• Conditions: Disability Physical; Chronic Conditions, Multiple; Aging
• Interventions: Behavioral: Lakeshore Online Fitness (Online); Behavioral: Get Active with Virtual Reality (VR)

• Registration Number: NCT05247242
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-18
• Study Start: 2022-07-19
• Primary Completion: 2023-12-27
• Study Completion: 2023-12-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tarrant Community Fitness Program: LOF-VR	Lakeshore Online Fitness (Online)	LOF-VR
Tarrant Community Fitness Program: VR-LOF	Lakeshore Online Fitness (Online)	VR-LOF
Tarrant Community Fitness Program: VR-LOF	Get Active with Virtual Reality (VR)	VR-LOF
Tarrant Community Fitness Program: LOF-VR	Get Active with Virtual Reality (VR)	LOF-VR

Primary Outcome Measures

Name	Time	Method
Change in Social Isolation from Baseline to 12 weeks	12 Weeks	PROMIS Item Bank v2.0 - Social Isolation - SF 8a

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tarrant Parks and Recreation; 🇺🇸 Tarrant, Alabama, United States