Exploring Virtual Reality Adventure Training Exergaming

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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, heart rate variability) among women 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 women 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.

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

Conditions
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Depression, Cognitive Function, Physical Activity, Sedentary Behavior, Post Traumatic Stress Disorder, Quality of Life, Heart Rate Variability, Anxiety

Intervention / Treatment
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* Device: Virtual Reality-based physical activity intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are between the ages of 18 and 45 Are a woman 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two group (intervention and control) randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 24 sessions over 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-8-week training, and one-month follow-up. | Device: Virtual Reality-based physical activity intervention<br>* The V-RATE intervention will be delivered through a 360-degree non-mobilized treadmill in a university clinical laboratory for 8-weeks (3 days/week, 30 minutes/session) totaling 24 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.<br>|
| No Intervention: Control<br>Control participants will not receive the intervention. Participants will complete measures at baseline, 8 weeks, and one-month follow-up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression from baseline to week 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 8, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety change from baseline to week 8 and one-month follow-up (Week 12) | Anxiety will be measured using the Beck Anxiety Inventory (BAI). | Baseline, Week 8, Week 24 | 
| Posttraumatic Stress change from baseline to week 8 and one-month follow-up (Week 12) | Posttraumatic Stress will be measured using the Posttraumatic Stress Disorder Checklist-5 (PCL-5). | Baseline, Week 8, Week 24 | 
| Cognitive Function change from baseline to week 8 and one-month follow-up (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. | Baseline, Week 8, Week 24 | 
| Health-Related Quality of Life (HRQOL) change from baseline to week 8 and one-month follow-up (Week 12) | Health-Related Quality of Life (HRQOL) will be measured using the Short Form-36 Health Survey. | Baseline, Week 8, Week 24 | 
| BMI change from baseline to week 8 and one-month follow-up (Week 12) | Participants' height and weight will be measured to calculate their BMI. | Baseline, Week 8, Week 24 | 
| Physical Activity and Sedentary Behavior change from baseline to week 8 and one-month follow-up (Week 12) | Physical Activity and Sedentary Behavior will be measured objectively using the ActiGraph GT9X accelerometers | Baseline, Week 8, Week 24 | 
| Heart Rate Variability (SDNN, rMSSD, LF, HF) change from baseline to week 8 and one-month follow-up (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. | Baseline, Week 8, Week 24 |