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Clinical Trials/NCT05563805
NCT05563805
Recruiting
N/A

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

The University of Texas at Arlington1 site in 1 country40 target enrollmentSeptember 7, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Physical Activity
Sponsor
The University of Texas at Arlington
Enrollment
40
Locations
1
Primary Endpoint
Change in depression from baseline to week 6-8 and one-month follow-up (Week 12)
Status
Recruiting
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2022
End Date
December 31, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Donna L. Schuman

Assistant Professor

The University of Texas at Arlington

Eligibility Criteria

Inclusion Criteria

  • Are between the ages of 18 and 45
  • Identify as a U.S. military veteran
  • 4\. 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.

Outcomes

Primary Outcomes

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

  • Anxiety change from baseline to week 6-8 and one-month follow-up (Week 12)(Baseline, post-training, Week 12)
  • Posttraumatic Stress change from baseline to week 8 and one-month follow-up (Week 12)(Baseline, post-training, Week 12)
  • Cognitive Function change from baseline to week 8 and one-month follow-up (Week 12)(Baseline, post-training, Week 12)
  • 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)
  • BMI change from baseline to week 6-8 and one-month follow-up (Week 12)(Baseline, post-training, Week 12)
  • Physical Activity and Sedentary Behavior change from baseline to week 8 and one-month follow-up (Week 12)(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)(Baseline, post-training, Week 12)

Study Sites (1)

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