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NCT Number: NCT05563805

Exploring Virtual Reality Adventure Training Exergaming

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.

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Key information

Conditions

Physical Activity Anxiety Anxiety Disorders Behavior Behavioral Symptoms Cognitive Function Depression Mental Disorders Motor Activity Post Traumatic Stress Disorder Quality of Life Sedentary Behavior Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed. The project addresses two specific aims:

Aim 1. To examine the effects of an 8-week V-RATE intervention on physical health (i.e., BMI, physical activity, sedentary behavior) among veterans. We hypothesize that after controlling for socio-demographic variables and physical activity history, individuals in the V-RATE group would exhibit more improvement in the physical health indicators after the intervention compared to individuals in the control group. We further hypothesize gains would be maintained or enhanced at 1-month follow-up measure.

Aim 2. To examine the effects of an 8-week V-RATE intervention on mental health outcomes (i.e., depression, anxiety, posttraumatic stress, cognitive function, health-related quality of life), among veterans. We hypothesize that after controlling for socio-demographic variables and physical activity history, individuals in the V-RATE group will exhibit more improvement in the mental health indicators after the intervention compared to individuals in the control group. We further hypothesize gains maintained or enhanced at 1-month follow-up measure.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline, Week 6-8, Week 12

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

Secondary outcomes

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

    Time frame: Baseline, post-training, Week 12

    Anxiety will be measured using the Beck Anxiety Inventory (BAI).

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

    Time frame: Baseline, post-training, Week 12

    Posttraumatic Stress will be measured using the Posttraumatic Stress Disorder Checklist-5 (PCL-5).

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

    Time frame: Baseline, post-training, Week 12

    Cognitive Function will be measured via the Cambridge Neuropsychological Test Automated Battery (CANTAB) to assess the participants' executive function and working memory via multitasking test and spatial working memory tests.

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

    Time frame: Baseline, Week 6-8, Week 24

    Health-Related Quality of Life (HRQOL) will be measured using the Short Form-36 Health Survey.

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

    Time frame: Baseline, post-training, Week 12

    Participants' height and weight will be measured to calculate their BMI.

  6. Physical Activity and Sedentary Behavior change from baseline to week 8 and one-month follow-up (Week 12)

    Time frame: Baseline, Week 8, Week 24

    Physical Activity and Sedentary Behavior will be measured objectively using the ActiGraph GT9X accelerometers

  7. Heart Rate Variability (SDNN, rMSSD, LF, HF) change from baseline to week 8 and one-month follow-up (Week 12)

    Time frame: Baseline, post-training, Week 12

    Heart Rate Variability will be measured using ECG (electrocardiogram)-derived heart rate variability from a Polar H10 Heart Rate Monitor Chest strap and HRV-monitoring app.

Study contacts

Contact information is provided by the study sponsor or research team.

Donna L Schuman, PhD

CONTACT

[email protected]

18172723181

Xiangli Gu, PhD

CONTACT

[email protected]

817-818-2106

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Registry information

Official study title

Exploring Virtual Reality Adventure Training Exergaming (V-RATE) on Veterans' Health Outcomes

Acronym: V-RATE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2022
Registry last updated
Jun 1, 2026

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

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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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