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Clinical Trials/NCT05247242
NCT05247242
Completed
N/A

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 enrollmentJuly 19, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Disability Physical
Sponsor
University of Alabama at Birmingham
Enrollment
10
Locations
1
Primary Endpoint
Change in Social Isolation from Baseline to 12 weeks
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
July 19, 2022
End Date
December 27, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laurie A Malone, PhD

Researcher IV

University of Alabama at Birmingham

Eligibility Criteria

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

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)

Study Sites (1)

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