Disability PhysicalNCT05247242
Physical Activity and Social Engagement for Persons With Disabilities in an Underserved Community
A study testing Lakeshore Online Fitness (Online) and Get Active with Virtual Reality (VR) in people with Disability Physical and Chronic Conditions, Multiple, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disability Physical, Chronic Conditions, Multiple, Aging
- What is being tested?
- Lakeshore Online Fitness (Online) and Get Active with Virtual Reality (VR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 27 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident of Tarrant, Alabama
- 18 years or older with a physical disability or chronic health condition or older than 60 years
- Fluent in English
Who cannot join
- Visual impairment that interferes with television viewing
Trial locations and contacts
1 site in 1 country.
United States1 site
Tarrant Parks and Recreation
Tarrant, Alabama, 35217
About this study
Official title: Physical Activity and Social Engagement Program for Persons With Disabilities and Chronic Health Conditions in an Underserved Birmingham Community
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).
Read the 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.
- Conditions
- Disability Physical, Chronic Conditions, Multiple, Aging
- Being tested
- Lakeshore Online Fitness (Online), Get Active with Virtual Reality (VR)
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lakeshore Online Fitness (Online)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tarrant Community Fitness Program: LOF-VR | Experimental | LOF-VR Receives: Behavioral: Lakeshore Online Fitness (Online); Behavioral: Get Active with Virtual Reality (VR) |
| Tarrant Community Fitness Program: VR-LOF | Experimental | VR-LOF Receives: Behavioral: Lakeshore Online Fitness (Online); Behavioral: Get Active with Virtual Reality (VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Isolation from Baseline to 12 weeks
PROMIS Item Bank v2.0 - Social Isolation - SF 8a
Measured: 12 Weeks
Secondary outcomes (7)
Change in Self-efficacy from Baseline to 12 weeks
Self-efficacy for Exercise (SEE) Scale
Measured: 12 Weeks
Change in Loneliness from Baseline to 12 weeks
NIH Toolbox Item Bank v2.0-Loneliness (Ages 18+)-Fixed Form
Measured: 12 Weeks
Change in Positive Affect from Baseline to 12 weeks
NIH Toolbox Item Bank v2.0-Positive Affect
Measured: 12 Weeks
Change in Health-related quality of life from Baseline to 12 weeks
SF-36v2
Measured: 12 Weeks
Change in Physical activity from Baseline to 12 weeks
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Measured: 12 Weeks
Change in Enjoyment from Baseline to 12 weeks
Visual Analog Scale (VAS) \& Modified Physical Activity Enjoyment Scale (PACES)
Measured: 12 Weeks
Change in Physical Function from Baseline to 12 weeks
Physical Function - Short Form 20a
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start19 Jul 2022
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lakeshore Foundation
- Responsible party
- Principal investigator, Laurie A Malone, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247242
- Sponsor's protocol ID
- IRB - 300008762
- Other IDs
- IRB-300008762
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2022
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Social Engagement Program for Persons With Disabilities and Chronic Health Conditions in an Underserved Birmingham Community
- ClinicalTrials.gov ID
- NCT05247242
- Acronym / sponsor ID
- IRB - 300008762
- Conditions
- Disability Physical, Chronic Conditions, Multiple, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Lakeshore Foundation
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tarrant Community Fitness Program: LOF-VR | Experimental | Behavioral: Lakeshore Online Fitness (Online), Behavioral: Get Active with Virtual Reality (VR)LOF-VR |
| Tarrant Community Fitness Program: VR-LOF | Experimental | Behavioral: Lakeshore Online Fitness (Online), Behavioral: Get Active with Virtual Reality (VR)VR-LOF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resident of Tarrant, Alabama
- 18 years or older with a physical disability or chronic health condition or older than 60 years
- Fluent in English
Key exclusion criteria (1 listed)
- Visual impairment that interferes with television viewing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Tarrant Community Fitness Program: LOF-VR, Tarrant Community Fitness Program: VR-LOF |
| 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. | Behavioural | Tarrant Community Fitness Program: LOF-VR, Tarrant Community Fitness Program: VR-LOF |
Primary outcome
Change in Social Isolation from Baseline to 12 weeks
Time frame: 12 Weeks
PROMIS Item Bank v2.0 - Social Isolation - SF 8a
7 secondary outcomes
Change in Self-efficacy from Baseline to 12 weeks
Time frame: 12 Weeks
Change in Loneliness from Baseline to 12 weeks
Time frame: 12 Weeks
Change in Positive Affect from Baseline to 12 weeks
Time frame: 12 Weeks
Change in Health-related quality of life from Baseline to 12 weeks
Time frame: 12 Weeks
Change in Physical activity from Baseline to 12 weeks
Time frame: 12 Weeks
Change in Enjoyment from Baseline to 12 weeks
Time frame: 12 Weeks
Change in Physical Function from Baseline to 12 weeks
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Disability Physical
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Recruiting
Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities
Disabilities Physical, Falls
RecruitingPhase 2
Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.
Hospital Associated Disability, Immobility
Not yet recruiting
Examining the Health Impact of and Promoting Sitting Light Volleyball in the Greater Bay Area
Physial Disabilities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lakeshore Online Fitness (Online) and Get Active with Virtual Reality (VR) in people with Disability Physical and Chronic Conditions, Multiple, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social Isolation from Baseline to 12 weeks (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.