Physical ActivityV-RATENCT05563805
Exploring Virtual Reality Adventure Training Exergaming
A study testing Virtual Reality-based physical activity intervention in people with Physical Activity and Sedentary Behavior, run by The University of Texas at Arlington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Behavior, Depression
- What is being tested?
- Virtual Reality-based physical activity intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are between the ages of 18 and 45
- Identify as a U.S. military veteran
- 4. Normal vision (no colorblindness)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas at Arlington
Arlington, Texas, 76019
Donna L Schuman, PhD, 817-272-3181, donna.schuman@uta.edu
Xiangli L Gu, PhD, 817-818-2106, donna.schuman@uta.edu
About this study
Official title: Exploring Virtual Reality Adventure Training Exergaming (V-RATE) on Veterans' Health Outcomes
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.
Read the 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.
- Conditions
- Physical Activity, Sedentary Behavior, Depression, Cognitive Function, Post Traumatic Stress Disorder, Quality of Life
- Being tested
- Virtual Reality-based physical activity intervention
- Medical subject headings
- Motor Activity, Sedentary Behavior, Depression, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-based physical activity interventionDevice
The V-RATE intervention will be delivered through a 360-degree non-mobilized treadmill in a university clinical laboratory for 6-8-weeks (1-2 days/week, 30 minutes/session) totaling 6 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 6 sessions over 6-8 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-training, and one-month follow-up. Receives: Device: Virtual Reality-based physical activity intervention |
| Control | No intervention | Control participants will not receive the intervention. Participants will complete measures at baseline, post-training, and one-month follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression from baseline to week 6-8 and one-month follow-up (Week 12)
Depression will be measured by self-report using the nine-item Patient Health Questionnaire-9 (PHQ-9).
Measured: Baseline, Week 6-8, Week 12
Secondary outcomes (7)
Anxiety change from baseline to week 6-8 and one-month follow-up (Week 12)
Anxiety will be measured using the Beck Anxiety Inventory (BAI).
Measured: Baseline, post-training, Week 12
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).
Measured: Baseline, post-training, Week 12
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.
Measured: Baseline, post-training, Week 12
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.
Measured: Baseline, Week 6-8, Week 24
BMI change from baseline to week 6-8 and one-month follow-up (Week 12)
Participants' height and weight will be measured to calculate their BMI.
Measured: Baseline, post-training, Week 12
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
Measured: 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)
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.
Measured: Baseline, post-training, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start7 Sep 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two group (intervention and control) randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna L. Schuman, The University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563805
- Sponsor's protocol ID
- UTexasArlington
- Acronym
- V-RATE
- Status last verified
- May 2026
- First submitted
- 28 Sep 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Virtual Reality Adventure Training Exergaming (V-RATE) on Veterans' Health Outcomes
- ClinicalTrials.gov ID
- NCT05563805
- Acronym / sponsor ID
- V-RATE / UTexasArlington
- Conditions
- Physical Activity, Sedentary Behavior, Depression, Cognitive Function, Post Traumatic Stress Disorder, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two group (intervention and control) randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Virtual Reality-based physical activity interventionintervention 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 6 sessions over 6-8 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-training, and one-month follow-up. |
| Control | No intervention | –Control participants will not receive the intervention. Participants will complete measures at baseline, post-training, and one-month follow-up. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Are between the ages of 18 and 45
- Identify as a U.S. military veteran
- 4. Normal vision (no colorblindness)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-based physical activity interventionThe V-RATE intervention will be delivered through a 360-degree non-mobilized treadmill in a university clinical laboratory for 6-8-weeks (1-2 days/week, 30 minutes/session) totaling 6 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. | Device | Intervention |
Primary outcome
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).
7 secondary outcomes
Anxiety change from baseline to week 6-8 and one-month follow-up (Week 12)
Time frame: Baseline, post-training, Week 12
Posttraumatic Stress change from baseline to week 8 and one-month follow-up (Week 12)
Time frame: Baseline, post-training, Week 12
Cognitive Function change from baseline to week 8 and one-month follow-up (Week 12)
Time frame: Baseline, post-training, Week 12
Health-Related Quality of Life (HRQOL) change from baseline to week 8 and one-month follow-up (Week 12)
Time frame: Baseline, Week 6-8, Week 24
BMI change from baseline to week 6-8 and one-month follow-up (Week 12)
Time frame: Baseline, post-training, Week 12
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
Heart Rate Variability (SDNN, rMSSD, LF, HF) change from baseline to week 8 and one-month follow-up (Week 12)
Time frame: Baseline, post-training, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-based physical activity intervention in people with Physical Activity and Sedentary Behavior, run by The University of Texas at Arlington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna L Schuman, PhD (18172723181, donna.schuman@uta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression from baseline to week 6-8 and one-month follow-up (Week 12) (time frame: Baseline, Week 6-8, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.