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Completed

NCT Number: NCT07155213

Adapted High-Intensity Virtual Reality Exergaming

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UAB Wellness Health and Research Facility

Birmingham, Alabama, 35209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Exergaming

Behavioral

High-intensity active video gaming using head-mounted display.

Primary outcomes

  1. Total lean mass

    Time frame: week 0, week 7

    lbs

  2. Total fat mass

    Time frame: Week 0, Week 7

    lbs

  3. Systolic blood pressure

    Time frame: Week 0, week 7

    mmHg

  4. high sensitivity C-reactive protein (hsCRP)

    Time frame: Week 0, Week 7

    mg/L

  5. hemoglobin A1c (HbA1C)

    Time frame: Week 0, week 7

    mmol/mol

  6. fasting insulin

    Time frame: Week 0, week 7

    μIU/mL

  7. Total cholesterol

    Time frame: Week 0, week 7

    mg/dL

  8. Low-density lipoprotein

    Time frame: Week 0, week 7

    mg/dL

  9. High-density lipoprotein

    Time frame: Week 0, week 7

    mg/dL

  10. Diastolic blood pressure

    Time frame: Week 0, week 7

    mmHg

Secondary outcomes

  1. Peak oxygen consumption (pVO2)

    Time frame: Week 0, Week 7

    mlkg/min

  2. Total work output

    Time frame: Week 0, Week 7

    watts

  3. Resting heart rate

    Time frame: Week 0, week 7

    beats/min

Other outcomes

  1. 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).

  2. 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.

  3. 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.

  4. Frequency of technical problems with the technology and exercise

    Time frame: Week 0 - 7

    Participant report: 1) frequency of problems reported

  5. Type of technical problems with the technology and exercise

    Time frame: Week 0 - 7

    Participant report: 1) Type of problem

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Feasibility of Vigorous Extended Reality Exergaming on Cardiometabolic Health in Youth With Mobility Disabilities: A Case Series

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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