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

Primary Purpose

Disability Physical, Chronic Conditions, Multiple, Aging

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lakeshore Online Fitness (Online)
Get Active with Virtual Reality (VR)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Disability Physical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tarrant Parks and RecreationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tarrant Community Fitness Program: LOF-VR

Tarrant Community Fitness Program: VR-LOF

Arm Description

LOF-VR

VR-LOF

Outcomes

Primary Outcome Measures

Change in Social Isolation from Baseline to 12 weeks
PROMIS Item Bank v2.0 - Social Isolation - SF 8a

Secondary Outcome Measures

Change in Self-efficacy from Baseline to 12 weeks
Self-efficacy for Exercise (SEE) Scale
Change in Loneliness from Baseline to 12 weeks
NIH Toolbox Item Bank v2.0-Loneliness (Ages 18+)-Fixed Form
Change in Positive Affect from Baseline to 12 weeks
NIH Toolbox Item Bank v2.0-Positive Affect
Change in Health-related quality of life from Baseline to 12 weeks
SF-36v2
Change in Physical activity from Baseline to 12 weeks
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Change in Enjoyment from Baseline to 12 weeks
Visual Analog Scale (VAS) & Modified Physical Activity Enjoyment Scale (PACES)
Change in Physical Function from Baseline to 12 weeks
Physical Function - Short Form 20a

Full Information

First Posted
January 18, 2022
Last Updated
April 14, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Lakeshore Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05247242
Brief Title
Physical Activity and Social Engagement for Persons With Disabilities in an Underserved Community
Official Title
Physical Activity and Social Engagement Program for Persons With Disabilities and Chronic Health Conditions in an Underserved Birmingham Community
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Lakeshore Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disability Physical, Chronic Conditions, Multiple, Aging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tarrant Community Fitness Program: LOF-VR
Arm Type
Experimental
Arm Description
LOF-VR
Arm Title
Tarrant Community Fitness Program: VR-LOF
Arm Type
Experimental
Arm Description
VR-LOF
Intervention Type
Behavioral
Intervention Name(s)
Lakeshore Online Fitness (Online)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Get Active with Virtual Reality (VR)
Intervention Description
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 Outcome Measure Information:
Title
Change in Social Isolation from Baseline to 12 weeks
Description
PROMIS Item Bank v2.0 - Social Isolation - SF 8a
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Change in Self-efficacy from Baseline to 12 weeks
Description
Self-efficacy for Exercise (SEE) Scale
Time Frame
12 Weeks
Title
Change in Loneliness from Baseline to 12 weeks
Description
NIH Toolbox Item Bank v2.0-Loneliness (Ages 18+)-Fixed Form
Time Frame
12 Weeks
Title
Change in Positive Affect from Baseline to 12 weeks
Description
NIH Toolbox Item Bank v2.0-Positive Affect
Time Frame
12 Weeks
Title
Change in Health-related quality of life from Baseline to 12 weeks
Description
SF-36v2
Time Frame
12 Weeks
Title
Change in Physical activity from Baseline to 12 weeks
Description
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Time Frame
12 Weeks
Title
Change in Enjoyment from Baseline to 12 weeks
Description
Visual Analog Scale (VAS) & Modified Physical Activity Enjoyment Scale (PACES)
Time Frame
12 Weeks
Title
Change in Physical Function from Baseline to 12 weeks
Description
Physical Function - Short Form 20a
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Evans
Phone
205-849-2800
Ext
1502
Email
sevans@cityoftarrant.com
Facility Information:
Facility Name
Tarrant Parks and Recreation
City
Tarrant
State/Province
Alabama
ZIP/Postal Code
35217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Evans
Phone
205-849-2800
Ext
1502
Email
sevans@cityoftarrant.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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