Exploring Virtual Reality Adventure Training Exergaming (V-RATE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Quality of Life; Physical Activity; Anxiety; Post Traumatic Stress Disorder; Cognitive Function; Sedentary Behavior; Heart Rate Variability
• Intervention / Treatment: Device: Virtual Reality-based physical activity intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donna L Schuman, PhD; Phone Number: 18172723181; Email: donna.schuman@uta.edu
• Study Contact Backup: Name: Xiangli Gu, PhD; Phone Number: 817-818-2106; Email: xiangli.gu@uta.edu

Study Locations

• United States
  • Texas
    • Arlington, Texas, United States, 76019
      • Recruiting
      • University of Texas at Arlington
      • Contact: Donna L Schuman, PhD; Phone Number: 817-272-3181; Email: donna.schuman@uta.edu
      • Contact: Xiangli L Gu, PhD; Phone Number: 817-818-2106; Email: donna.schuman@uta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Are between the ages of 18 and 45
2. Are a woman
3. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 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; 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.
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: The University of Texas at Arlington

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: UTexasArlington

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes