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Exploring Virtual Reality Adventure Training Exergaming (V-RATE)

Primary Purpose

Physical Activity, Sedentary Behavior, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality-based physical activity intervention
Sponsored by
The University of Texas at Arlington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Activity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Texas at ArlingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Control participants will not receive the intervention. Participants will complete measures at baseline, 8 weeks, and one-month follow-up.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Anxiety change from baseline to week 8 and one-month follow-up (Week 12)
Anxiety will be measured using the Beck Anxiety Inventory (BAI).
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).
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.
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.
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.
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
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.

Full Information

First Posted
September 28, 2022
Last Updated
October 2, 2023
Sponsor
The University of Texas at Arlington
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1. Study Identification

Unique Protocol Identification Number
NCT05563805
Brief Title
Exploring Virtual Reality Adventure Training Exergaming
Acronym
V-RATE
Official Title
Exploring Virtual Reality Adventure Training Exergaming (V-RATE) on Women Veterans' Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Arlington

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Sedentary Behavior, Depression, Cognitive Function, Post Traumatic Stress Disorder, Quality of Life, Heart Rate Variability, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group (intervention and control) randomized trial
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control participants will not receive the intervention. Participants will complete measures at baseline, 8 weeks, and one-month follow-up.
Intervention Type
Device
Intervention Name(s)
Virtual Reality-based physical activity intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in depression from baseline to week 8 and one-month follow-up (Week 12)
Description
Depression will be measured by self-report using the nine-item Patient Health Questionnaire-9 (PHQ-9).
Time Frame
Baseline, Week 8, Week 24
Secondary Outcome Measure Information:
Title
Anxiety change from baseline to week 8 and one-month follow-up (Week 12)
Description
Anxiety will be measured using the Beck Anxiety Inventory (BAI).
Time Frame
Baseline, Week 8, Week 24
Title
Posttraumatic Stress change from baseline to week 8 and one-month follow-up (Week 12)
Description
Posttraumatic Stress will be measured using the Posttraumatic Stress Disorder Checklist-5 (PCL-5).
Time Frame
Baseline, Week 8, Week 24
Title
Cognitive Function change from baseline to week 8 and one-month follow-up (Week 12)
Description
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.
Time Frame
Baseline, Week 8, Week 24
Title
Health-Related Quality of Life (HRQOL) change from baseline to week 8 and one-month follow-up (Week 12)
Description
Health-Related Quality of Life (HRQOL) will be measured using the Short Form-36 Health Survey.
Time Frame
Baseline, Week 8, Week 24
Title
BMI change from baseline to week 8 and one-month follow-up (Week 12)
Description
Participants' height and weight will be measured to calculate their BMI.
Time Frame
Baseline, Week 8, Week 24
Title
Physical Activity and Sedentary Behavior change from baseline to week 8 and one-month follow-up (Week 12)
Description
Physical Activity and Sedentary Behavior will be measured objectively using the ActiGraph GT9X accelerometers
Time Frame
Baseline, Week 8, Week 24
Title
Heart Rate Variability (SDNN, rMSSD, LF, HF) change from baseline to week 8 and one-month follow-up (Week 12)
Description
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.
Time Frame
Baseline, Week 8, Week 24

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female sex at birth
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are between the ages of 18 and 45 Are a woman Identify as a U.S. military veteran 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna L Schuman, PhD
Phone
18172723181
Email
donna.schuman@uta.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangli Gu, PhD
Phone
817-818-2106
Email
xiangli.gu@uta.edu
Facility Information:
Facility Name
University of Texas at Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna L Schuman, PhD
Phone
817-272-3181
Email
donna.schuman@uta.edu
First Name & Middle Initial & Last Name & Degree
Xiangli L Gu, PhD
Phone
817-818-2106
Email
donna.schuman@uta.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Exploring Virtual Reality Adventure Training Exergaming

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