We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exploring Virtual Reality Adventure Training Exergaming (V-RATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05563805
Recruitment Status : Recruiting
First Posted : October 3, 2022
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
Donna L. Schuman, The University of Texas at Arlington

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
Physical Activity Sedentary Behavior Depression Cognitive Function Post Traumatic Stress Disorder Quality of Life Heart Rate Variability Anxiety Device: Virtual Reality-based physical activity intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two 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 : September 7, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

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.



Primary Outcome Measures :
  1. Change in depression from baseline to week 8 and one-month follow-up (Week 12) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female sex at birth
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05563805


Contacts
Layout table for location contacts
Contact: Donna L Schuman, PhD 18172723181 donna.schuman@uta.edu
Contact: Xiangli Gu, PhD 817-818-2106 xiangli.gu@uta.edu

Locations
Layout table for location information
United States, Texas
University of Texas at Arlington Recruiting
Arlington, Texas, United States, 76019
Contact: Donna L Schuman, PhD    817-272-3181    donna.schuman@uta.edu   
Contact: Xiangli L Gu, PhD    817-818-2106    donna.schuman@uta.edu   
Sponsors and Collaborators
The University of Texas at Arlington
Layout table for additonal information
Responsible Party: Donna L. Schuman, Assistant Professor, The University of Texas at Arlington
ClinicalTrials.gov Identifier: NCT05563805    
Other Study ID Numbers: UTexasArlington
First Posted: October 3, 2022    Key Record Dates
Last Update Posted: October 3, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders