V-RATE: Exploring Virtual Reality Adventure Training Exergaming

Sponsor
The University of Texas at Arlington (Other)
Overall Status
Recruiting
CT.gov ID
NCT05563805
Collaborator
(none)
40
1
2
11.8
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality-based physical activity intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two group (intervention and control) randomized trialTwo group (intervention and control) randomized trial
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Exploring Virtual Reality Adventure Training Exergaming (V-RATE) on Women Veterans' Health Outcomes
Actual Study Start Date :
Sep 7, 2022
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in depression from baseline to week 8 and one-month follow-up (Week 12) [Baseline, Week 8, Week 24]

    Depression will be measured by self-report using the nine-item Patient Health Questionnaire-9 (PHQ-9).

Secondary Outcome Measures

  1. Anxiety change from baseline to week 8 and one-month follow-up (Week 12) [Baseline, Week 8, Week 24]

    Anxiety will be measured using the Beck Anxiety Inventory (BAI).

  2. Posttraumatic Stress change from baseline to week 8 and one-month follow-up (Week 12) [Baseline, Week 8, Week 24]

    Posttraumatic Stress will be measured using the Posttraumatic Stress Disorder Checklist-5 (PCL-5).

  3. Cognitive Function change from baseline to week 8 and one-month follow-up (Week 12) [Baseline, Week 8, Week 24]

    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.

  4. Health-Related Quality of Life (HRQOL) change from baseline to week 8 and one-month follow-up (Week 12) [Baseline, Week 8, Week 24]

    Health-Related Quality of Life (HRQOL) will be measured using the Short Form-36 Health Survey.

  5. BMI change from baseline to week 8 and one-month follow-up (Week 12) [Baseline, Week 8, Week 24]

    Participants' height and weight will be measured to calculate their BMI.

  6. 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

  7. Heart Rate Variability (SDNN, rMSSD, LF, HF) change from baseline to week 8 and one-month follow-up (Week 12) [Baseline, Week 8, Week 24]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Texas at Arlington Arlington Texas United States 76019

Sponsors and Collaborators

  • The University of Texas at Arlington

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Donna L. Schuman, Assistant Professor, The University of Texas at Arlington
ClinicalTrials.gov Identifier:
NCT05563805
Other Study ID Numbers:
  • UTexasArlington
First Posted:
Oct 3, 2022
Last Update Posted:
Oct 3, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2022