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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Aging; Disability Physical; Chronic Conditions, Multiple
• Intervention / Treatment: Behavioral: Lakeshore Online Fitness (Online); Behavioral: 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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tarrant, Alabama, United States, 35217
      • Tarrant Parks and Recreation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tarrant Community Fitness Program: LOF-VR; LOF-VR	Behavioral: Lakeshore Online Fitness (Online); 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.; Behavioral: Get Active with Virtual Reality (VR); 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.
Experimental: Tarrant Community Fitness Program: VR-LOF; VR-LOF	Behavioral: Lakeshore Online Fitness (Online); 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.; Behavioral: Get Active with Virtual Reality (VR); 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.

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Lakeshore Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Actual): December 27, 2023
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease; Chronic Disease; Multiple Chronic Conditions
• Other Study ID Numbers: IRB - 300008762; Internal grant (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No