Exploring Virtual Reality Adventure Training Exergaming

NCT05563805 | Recruiting DMC FDA Device

• 1 other identifier: UTexasArlington
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on women veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed to examine effects on physical and mental health outcomes.

Conditions

Physical Activity; Sedentary Behavior; Depression; Cognitive Function; Post Traumatic Stress Disorder; Quality of Life; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in depression from baseline to week 6-8 and one-month follow-up (Week 12)

  Depression will be measured by self-report using the nine-item Patient Health Questionnaire-9 (PHQ-9).

  Baseline, Week 6-8, Week 12

Secondary Outcomes (7)

• Anxiety change from baseline to week 6-8 and one-month follow-up (Week 12)

  Baseline, post-training, Week 12

• Posttraumatic Stress change from baseline to week 8 and one-month follow-up (Week 12)

  Baseline, post-training, Week 12

• Cognitive Function change from baseline to week 8 and one-month follow-up (Week 12)

  Baseline, post-training, Week 12

• Health-Related Quality of Life (HRQOL) change from baseline to week 8 and one-month follow-up (Week 12)

  Baseline, Week 6-8, Week 24

• BMI change from baseline to week 6-8 and one-month follow-up (Week 12)

  Baseline, post-training, Week 12

Study Arms (2)

Intervention

EXPERIMENTAL

intervention participants will engage in a 30-minutes VR adventure games on a non-mobilized treadmill (5-min warm-up, 20-minutes treadmill, and 5-min cool-down) for a total of 6 sessions over 6-8 weeks. Participants in the V-RATE group will be instructed to self-pace walking/running on the treadmill while they are fully immersed in the VR games for two 10-minute bouts with a complete rest interval (heart rate reduces to normal range). Participants will complete measures at baseline, post-training, and one-month follow-up.

Device: Virtual Reality-based physical activity intervention

Control

NO INTERVENTION

Control participants will not receive the intervention. Participants will complete measures at baseline, post-training, and one-month follow-up.

Interventions

Virtual Reality-based physical activity intervention DEVICE

The V-RATE intervention will be delivered through a 360-degree non-mobilized treadmill in a university clinical laboratory for 6-8-weeks (1-2 days/week, 30 minutes/session) totaling 6 sessions. The V-RATE program will be focused on creating a safe and immersive environment supportive of physical activity. The treadmill enables an individual can walk and run at self-paced speed, moving in 360-degrees (i.e., forwards, sideways, and backwards) without risk of falling. The core feature of the self-paced treadmill is a concave walking platform with an adjustable waist hardness that enables a safe, smooth, natural gait while adults with elevated BMI engage in an immersive walking and running motion. During the V-RATE intervention, participants will self-pace their locomotor action (walking/running/bending/ jumping) while they wear the VR headset and experience immersive VR adventure games using the Omniverse VR system.

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female sex at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are between the ages of 18 and 45
• Identify as a U.S. military veteran
• \. Normal vision (no colorblindness)

You may not qualify if:

• Unable to walk independently (e.g., use of any mobility assistive device such as brace, wheelchair, cane, crutch, walker, knee scooter)
• Self-reported joint problem that limits mobility (e.g., arthritis or other condition that would prevent participation) or ongoing orthopedic injury
• Self-reported pregnancy or suspicion of pregnancy
• Self-reported motor disorder or impaired sense of motion or balance (such as Parkinsonism)
• Self-reported color blindness
• Self-reported neurological or cognitive disorder (e.g., TBI, history of seizure)
• Self-reported cardiac surgery or any ongoing cardiovascular issues preventing participation or physical activity.

Sponsors & Collaborators

• The University of Texas at Arlington: lead

Study Sites (1)

University of Texas at Arlington

Arlington, Texas, 76019, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior; Depression; Stress Disorders, Post-Traumatic; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Donna L Schuman, PhD

CONTACT

18172723181; donna.schuman@uta.edu

Xiangli Gu, PhD

CONTACT

817-818-2106; xiangli.gu@uta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two group (intervention and control) randomized trial

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: September 7, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)