An interventional study of Lakeshore Online Fitness (Online) and Get Active with Virtual Reality (VR) in Disability Physical, Chronic Conditions, Multiple and Aging, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other
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).
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.
89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.
This study's enrollment of 10 is below the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.
Browse Multiple Chronic Conditions studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
LOF-VR
Behavioral: Lakeshore Online Fitness (Online) · Behavioral: Get Active with Virtual Reality (VR)
VR-LOF
Behavioral: Lakeshore Online Fitness (Online) · Behavioral: Get Active with Virtual Reality (VR)
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.
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.
Change in Social Isolation from Baseline to 12 weeks
PROMIS Item Bank v2.0 - Social Isolation - SF 8a
Time frame: 12 Weeks
Change in Self-efficacy from Baseline to 12 weeks
Self-efficacy for Exercise (SEE) Scale
Time frame: 12 Weeks
Change in Loneliness from Baseline to 12 weeks
NIH Toolbox Item Bank v2.0-Loneliness (Ages 18+)-Fixed Form
Time frame: 12 Weeks
Change in Positive Affect from Baseline to 12 weeks
NIH Toolbox Item Bank v2.0-Positive Affect
Time frame: 12 Weeks
Change in Health-related quality of life from Baseline to 12 weeks
SF-36v2
Time frame: 12 Weeks
Change in Physical activity from Baseline to 12 weeks
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Time frame: 12 Weeks
Change in Enjoyment from Baseline to 12 weeks
Visual Analog Scale (VAS) \& Modified Physical Activity Enjoyment Scale (PACES)
Time frame: 12 Weeks
Change in Physical Function from Baseline to 12 weeks
Physical Function - Short Form 20a
Time frame: 12 Weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Dec 2023, 17 months.
Of 59 non-industry interventional studies with no phase under Multiple Chronic Conditions, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's 17 months is below that.
Counting every sponsor, half of 59 studies reached it within 20 months; a quarter within 11 and three quarters within 37.
Multiple Chronic Conditions covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →