Exploring Virtual Reality Adventure Training Exergaming

Depression Clinical Trial

— V-RATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563805
• Other study ID #: UTexasArlington
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: The University of Texas at Arlington
• Contact: Donna L Schuman, PhD
• Phone: 18172723181
• Email: donna.schuman[@]uta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas at Arlington	Arlington	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at Arlington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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