Recruiting

V-RATE

Sponsor:

The University of Texas at Arlington

Code:

NCT05563805

Conditions

Physical Activity

Sedentary Behavior

Depression

Cognitive Function

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Virtual Reality-based physical activity intervention

Study Details

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

Study ID

NCT05563805

Start date

Sep 7, 2022

Status verified date

May, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Are between the ages of 18 and 45
2. Identify as a U.S. military veteran

4\. Normal vision (no colorblindness)

Exclusion Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

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.

no intervention: Control

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

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.

Primary outcome measure

  • Change in depression from baseline to week 6-8 and one-month follow-up (Week 12) [ Time Frame: Baseline, Week 6-8, Week 12 ]

Central Contacts and Locations

Central contacts

Donna L Schuman, PhD

18172723181donna.schuman@uta.edu

Xiangli Gu, PhD

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

Locations

University of Texas at Arlington

Recruiting

Arlington, Texas, United States, 76019

Contacts

Donna L Schuman, PhD

817-272-3181donna.schuman@uta.edu

Xiangli L Gu, PhD

817-818-2106donna.schuman@uta.edu

More Information

Sponsor

The University of Texas at Arlington

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas at Arlington on 2026-06-01.