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Completed

NCT Number: NCT05247242

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

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Key information

Conditions

Disability Physical Aging Chronic Conditions, Multiple Chronic Disease Disease Attributes Multiple Chronic Conditions Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarrant Parks and Recreation

Tarrant, Alabama, 35217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lakeshore Online Fitness (Online)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Change in Social Isolation from Baseline to 12 weeks

    Time frame: 12 Weeks

    PROMIS Item Bank v2.0 - Social Isolation - SF 8a

Secondary outcomes

  1. Change in Self-efficacy from Baseline to 12 weeks

    Time frame: 12 Weeks

    Self-efficacy for Exercise (SEE) Scale

  2. Change in Loneliness from Baseline to 12 weeks

    Time frame: 12 Weeks

    NIH Toolbox Item Bank v2.0-Loneliness (Ages 18+)-Fixed Form

  3. Change in Positive Affect from Baseline to 12 weeks

    Time frame: 12 Weeks

    NIH Toolbox Item Bank v2.0-Positive Affect

  4. Change in Health-related quality of life from Baseline to 12 weeks

    Time frame: 12 Weeks

    SF-36v2

  5. Change in Physical activity from Baseline to 12 weeks

    Time frame: 12 Weeks

    Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)

  6. Change in Enjoyment from Baseline to 12 weeks

    Time frame: 12 Weeks

    Visual Analog Scale (VAS) & Modified Physical Activity Enjoyment Scale (PACES)

  7. Change in Physical Function from Baseline to 12 weeks

    Time frame: 12 Weeks

    Physical Function - Short Form 20a

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Lakeshore Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2022
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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