- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07155213
- Original Trial
Adapted High-Intensity Virtual Reality Exergaming
April 10, 2026 updated by: Byron Lai, University of Alabama at Birmingham
Feasibility of Vigorous Extended Reality Exergaming on Cardiometabolic Health in Youth With Mobility Disabilities: A Case Series
This study will test the acceptability and benefits of a home-based high-intensity virtual reality exercise program for young people with physical disabilities.
The program will last 6 weeks.
There will be a total of two visits to the laboratory for exercise-related health assessments.
The program includes head-mounted displays (Meta Quest) and off-the-shelf games.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35209
- UAB Wellness Health and Research Facility
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- overweight or obese (based on CDC body mass index normative ranges for age and sex)
- physically inactive (<150 min/week of moderate exercise)
- Gross Motor Function Classification System level (GMFCS) levels I-IV
- Physician clearance to participate
- Wifi internet access at home
Exclusion Criteria:
- Complete blindness or deafness
- GMFCS level V
- Unable to communicate in English
- Prone to photosensitive seizures
- Pregnant (due to radiation from a Dual Energy X-ray Absorptiometry [DXA] scan
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Exergaming Intervention
High-intensity active video gaming at the home.
|
High-intensity active video gaming using head-mounted display.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total lean mass
Time Frame: week 0, week 7
|
lbs
|
week 0, week 7
|
|
Total fat mass
Time Frame: Week 0, Week 7
|
lbs
|
Week 0, Week 7
|
|
Systolic blood pressure
Time Frame: Week 0, week 7
|
mmHg
|
Week 0, week 7
|
|
high sensitivity C-reactive protein (hsCRP)
Time Frame: Week 0, Week 7
|
mg/L
|
Week 0, Week 7
|
|
hemoglobin A1c (HbA1C)
Time Frame: Week 0, week 7
|
mmol/mol
|
Week 0, week 7
|
|
fasting insulin
Time Frame: Week 0, week 7
|
μIU/mL
|
Week 0, week 7
|
|
Total cholesterol
Time Frame: Week 0, week 7
|
mg/dL
|
Week 0, week 7
|
|
Low-density lipoprotein
Time Frame: Week 0, week 7
|
mg/dL
|
Week 0, week 7
|
|
High-density lipoprotein
Time Frame: Week 0, week 7
|
mg/dL
|
Week 0, week 7
|
|
Diastolic blood pressure
Time Frame: Week 0, week 7
|
mmHg
|
Week 0, week 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak oxygen consumption (pVO2)
Time Frame: Week 0, Week 7
|
mlkg/min
|
Week 0, Week 7
|
|
Total work output
Time Frame: Week 0, Week 7
|
watts
|
Week 0, Week 7
|
|
Resting heart rate
Time Frame: Week 0, week 7
|
beats/min
|
Week 0, week 7
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adolescent Food Habits Checklist
Time Frame: Week 0, week 7
|
The short survey includes 23 items where the person can respond with True and False to a variety of healthy eating habit questions.
The survey is scored by a frequency count of 1 point for each 'healthy' response.
Final score achieved by summing number of 'healthy' responses x (23 / number of items completed).
|
Week 0, week 7
|
|
Frequency of technical problems with the technology and exercise
Time Frame: Week 0 - 7
|
Participant report: 1) frequency of problems reported
|
Week 0 - 7
|
|
Type of technical problems with the technology and exercise
Time Frame: Week 0 - 7
|
Participant report: 1) Type of problem
|
Week 0 - 7
|
|
Total minutes of intervention exercise
Time Frame: Week 0 - Week 6
|
Total minutes of virtual reality exercise performed each week will be recorded and divided by the total prescribed 240 minutes per week across the 6 week program.
|
Week 0 - Week 6
|
|
Total vigorous-intensity minutes of intervention exercise
Time Frame: Week 0 - Week 6
|
Vigorous-intensity minutes of virtual reality exercise performed each week will be recorded and divided by the target of 187 minutes per week across the 6 week program.
Vigorous-intensity will be defined as >75% of age predicted heart rate maximum.
|
Week 0 - Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 3, 2025
Primary Completion (Actual)
February 1, 2026
Study Completion (Actual)
April 1, 2026
Study Registration Dates
First Submitted
August 12, 2025
First Submitted That Met QC Criteria
September 2, 2025
First Posted (Actual)
September 4, 2025
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 10, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300014468
- CEDHARS Pilot 2025 (Other Grant/Funding Number: Center for Engagement in Disability Health and Rehabilitation Sciences)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All raw data will be published.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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