Exploring Virtual Reality Adventure Training Exergaming

Not Applicable

Recruiting

• Conditions: Physical Activity; Sedentary Behavior; Depression; Cognitive Function; Post Traumatic Stress Disorder; Quality of Life; Anxiety
• Interventions: Device: Virtual Reality-based physical activity intervention

• Registration Number: NCT05563805
• Lead Sponsor: The University of Texas at Arlington

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-09-07
• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Are between the ages of 18 and 45

2. Identify as a U.S. military veteran

3. 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Virtual Reality-based physical activity 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 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.

Primary Outcome Measures

Name	Time	Method
Change in depression from baseline to week 6-8 and one-month follow-up (Week 12)	Baseline, Week 6-8, Week 12	Depression will be measured by self-report using the nine-item Patient Health Questionnaire-9 (PHQ-9).

Secondary Outcome Measures

Name	Time	Method
Anxiety change from baseline to week 6-8 and one-month follow-up (Week 12)	Baseline, post-training, Week 12	Anxiety will be measured using the Beck Anxiety Inventory (BAI).
Posttraumatic Stress change from baseline to week 8 and one-month follow-up (Week 12)	Baseline, post-training, Week 12	Posttraumatic Stress will be measured using the Posttraumatic Stress Disorder Checklist-5 (PCL-5).
Cognitive Function change from baseline to week 8 and one-month follow-up (Week 12)	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.
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	Health-Related Quality of Life (HRQOL) will be measured using the Short Form-36 Health Survey.
BMI change from baseline to week 6-8 and one-month follow-up (Week 12)	Baseline, post-training, Week 12	Participants' height and weight will be measured to calculate their BMI.
Physical Activity and Sedentary Behavior change from baseline to week 8 and one-month follow-up (Week 12)	Baseline, Week 8, Week 24	Physical Activity and Sedentary Behavior will be measured objectively using the ActiGraph GT9X accelerometers
Heart Rate Variability (SDNN, rMSSD, LF, HF) change from baseline to week 8 and one-month follow-up (Week 12)	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.

Trial Locations

Locations (1)

University of Texas at Arlington; 🇺🇸 Arlington, Texas, United States