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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05247242
• Other study ID #: IRB - 300008762
• Secondary ID: Internal grant
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: November 30, 2024
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Chronic Conditions, Multiple
• Chronic Disease
• Disability Physical
• Disease
• Multiple Chronic Conditions

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Tarrant Parks and Recreation	Tarrant	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Lakeshore Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Social Isolation from Baseline to 12 weeks	PROMIS Item Bank v2.0 - Social Isolation - SF 8a	12 Weeks
Secondary	Change in Self-efficacy from Baseline to 12 weeks	Self-efficacy for Exercise (SEE) Scale	12 Weeks
Secondary	Change in Loneliness from Baseline to 12 weeks	NIH Toolbox Item Bank v2.0-Loneliness (Ages 18+)-Fixed Form	12 Weeks
Secondary	Change in Positive Affect from Baseline to 12 weeks	NIH Toolbox Item Bank v2.0-Positive Affect	12 Weeks
Secondary	Change in Health-related quality of life from Baseline to 12 weeks	SF-36v2	12 Weeks
Secondary	Change in Physical activity from Baseline to 12 weeks	Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)	12 Weeks
Secondary	Change in Enjoyment from Baseline to 12 weeks	Visual Analog Scale (VAS) & Modified Physical Activity Enjoyment Scale (PACES)	12 Weeks
Secondary	Change in Physical Function from Baseline to 12 weeks	Physical Function - Short Form 20a	12 Weeks