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Clinical Trials/NCT05247242
NCT05247242CompletedNot Applicable

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

University of Alabama at Birmingham1 site in 1 country10 target enrollmentStarted: July 19, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Change in Social Isolation from Baseline to 12 weeks

Study Overview

Brief 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).

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Tarrant Community Fitness Program: LOF-VR

Experimental

LOF-VR

Intervention: Lakeshore Online Fitness (Online) (Behavioral)

Tarrant Community Fitness Program: LOF-VR

Experimental

LOF-VR

Intervention: Get Active with Virtual Reality (VR) (Behavioral)

Tarrant Community Fitness Program: VR-LOF

Experimental

VR-LOF

Intervention: Lakeshore Online Fitness (Online) (Behavioral)

Tarrant Community Fitness Program: VR-LOF

Experimental

VR-LOF

Intervention: Get Active with Virtual Reality (VR) (Behavioral)

Outcomes

Primary Outcomes

Change in Social Isolation from Baseline to 12 weeks

Time Frame: 12 Weeks

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

Secondary Outcomes

  • Change in Loneliness from Baseline to 12 weeks(12 Weeks)
  • Change in Physical activity from Baseline to 12 weeks(12 Weeks)
  • Change in Health-related quality of life from Baseline to 12 weeks(12 Weeks)
  • Change in Physical Function from Baseline to 12 weeks(12 Weeks)
  • Change in Positive Affect from Baseline to 12 weeks(12 Weeks)
  • Change in Enjoyment from Baseline to 12 weeks(12 Weeks)
  • Change in Self-efficacy from Baseline to 12 weeks(12 Weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laurie A Malone, PhD

Researcher IV

University of Alabama at Birmingham

Study Sites (1)

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