Clinical trial NCT05563805: Exploring Virtual Reality Adventure Training Exergaming
Official title: Exploring Virtual Reality Adventure Training Exergaming (V-RATE) on Veterans' Health Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Activity
Sedentary Behavior
Depression
Cognitive Function
Post Traumatic Stress Disorder
Quality of Life
Anxiety
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group (intervention and control) randomized trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Are between the ages of 18 and 45
2. 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.

Primary outcomes:
measure: Change in depression from baseline to week 6-8 and one-month follow-up (Week 12)
timeFrame: Baseline, Week 6-8, Week 12
Secondary outcomes:
measure: Anxiety change from baseline to week 6-8 and one-month follow-up (Week 12)
timeFrame: Baseline, post-training, Week 12
measure: Posttraumatic Stress change from baseline to week 8 and one-month follow-up (Week 12)
timeFrame: Baseline, post-training, Week 12
measure: Cognitive Function change from baseline to week 8 and one-month follow-up (Week 12)
timeFrame: Baseline, post-training, Week 12
measure: Health-Related Quality of Life (HRQOL) change from baseline to week 8 and one-month follow-up (Week 12)
timeFrame: Baseline, Week 6-8, Week 24
measure: BMI change from baseline to week 6-8 and one-month follow-up (Week 12)
timeFrame: Baseline, post-training, Week 12
measure: Physical Activity and Sedentary Behavior change from baseline to week 8 and one-month follow-up (Week 12)
timeFrame: Baseline, Week 8, Week 24
measure: Heart Rate Variability (SDNN, rMSSD, LF, HF) change from baseline to week 8 and one-month follow-up (Week 12)
timeFrame: Baseline, post-training, Week 12
Other outcomes:
Locations:
city: Arlington
country: United States
facility: University of Texas at Arlington
state: Texas
Study officials:
References: