Adapted High-Intensity Virtual Reality Exergaming

NCT07155213 | Completed Early Phase 1

• 2 other identifiers: 300014468CEDHARS Pilot 2025
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

active video gaming; telehealth; telerehabilitation

Outcome Measures

Primary Outcomes (10)

• Total lean mass

  lbs

  week 0, week 7

• Total fat mass

  lbs

  Week 0, Week 7

• Systolic blood pressure

  mmHg

  Week 0, week 7

• high sensitivity C-reactive protein (hsCRP)

  mg/L

  Week 0, Week 7

• hemoglobin A1c (HbA1C)

  mmol/mol

  Week 0, week 7

• fasting insulin

  μIU/mL

  Week 0, week 7

• Total cholesterol

  mg/dL

  Week 0, week 7

• Low-density lipoprotein

  mg/dL

  Week 0, week 7

• High-density lipoprotein

  mg/dL

  Week 0, week 7

• Diastolic blood pressure

  mmHg

  Week 0, week 7

Secondary Outcomes (3)

• Peak oxygen consumption (pVO2)

  Week 0, Week 7

• Total work output

  Week 0, Week 7

• Resting heart rate

  Week 0, week 7

Other Outcomes (5)

• Adolescent Food Habits Checklist

  Week 0, week 7

• Total minutes of intervention exercise

  Week 0 - Week 6

• Total vigorous-intensity minutes of intervention exercise

  Week 0 - Week 6

Study Arms (1)

Virtual Reality Exergaming Intervention

EXPERIMENTAL

High-intensity active video gaming at the home.

Behavioral: Virtual reality exergaming

Interventions

Virtual reality exergaming BEHAVIORAL

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

Virtual Reality Exergaming Intervention

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Wellness Health and Research Facility

Birmingham, Alabama, 35209, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Virtual reality high-intensity exercise in either the seated or standing position.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 4, 2025
• Study Start: September 3, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)