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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
First received
Last updated
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
Health authority
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

Study Design


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
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