Virtual Reality Exergaming for Health Improvement

(V-RATE Trial)

Overseen By Donna L Schuman, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas at Arlington

Disqualifiers: Mobility issues, Pregnancy, Neurological, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6-8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how virtual reality games combined with treadmill exercise, known as Virtual Reality Adventure Therapy Exergaming (V-RATE), can improve physical and mental health in women veterans. Participants will play VR adventure games while walking or running on a treadmill over several weeks. The trial will compare results between those who use the VR exercise and those who do not. Women veterans with normal vision who can walk independently might be a good fit.

As an unphased trial, this study offers a unique opportunity for participants to explore innovative therapy methods that could enhance their well-being.

Do I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that Virtual Reality Adventure Therapy Exergaming is safe for women veterans?

Research shows that Virtual Reality Adventure Therapy Exergaming (V-RATE) is generally easy for people to handle. Reviews of similar therapies have found them to be as safe as regular physical activities. In studies of other exergaming systems, participants reported feeling better and less tired, with few negative effects.

This trial is in the early testing stages, so V-RATE is still being explored for this specific use. However, existing research on similar therapies suggests it is likely safe. Participants typically engage in the therapy at their own pace, which helps reduce any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Adventure Therapy Exergaming (V-RATE) because it combines the engaging element of virtual reality with physical exercise, offering a potentially more enjoyable and immersive way to improve physical fitness. Unlike traditional exercise routines that might feel monotonous or challenging to maintain, V-RATE immerses participants in adventure games that make physical activity feel like play rather than work. This novel approach could lead to better adherence to exercise programs and improved fitness outcomes, making it a promising alternative or complement to existing physical activity regimens. Additionally, the use of virtual reality could help distract from physical exertion, potentially reducing perceived effort and increasing exercise duration.

What evidence suggests that Virtual Reality Adventure Therapy Exergaming (V-RATE) is effective for improving physical and mental health outcomes in women veterans?

Research has shown that using virtual reality (VR) for exercise can improve physical health, enhancing movement and balance. It may also aid mental health issues such as depression and anxiety by making exercise more enjoyable and engaging. Early studies suggest that virtual reality exercise games, like V-RATE, could effectively boost both physical and mental health. In this trial, participants in the intervention arm will engage in V-RATE sessions to further explore these potential benefits. However, more research is needed to confirm these benefits specifically for women veterans. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

You have normal vision without colorblindness.

You are female.

You are female.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a Virtual Reality Adventure Therapy Exergaming intervention for 6-8 weeks, involving 30-minute VR adventure games on a treadmill for 6 sessions

6-8 weeks

6 sessions (in-person)

Follow-up

Participants are monitored for physical and mental health outcomes, including depression, anxiety, and physical activity, at a 1-month follow-up

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Adventure Therapy Exergaming (V-RATE)

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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 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.

Group II: Control Active Control 1 Intervention

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

Virtual Reality Adventure Therapy Exergaming (V-RATE) is already approved in United States for the following indications:

Approved in United States as V-RATE for:

• Physical health improvement
• Mental health improvement
• Depression
• Anxiety
• PTSD

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials

48

Recruited

7,300+

Published Research Related to This Trial

In a study involving 14 healthy adults, playing the Dance Central exer-game on the XBOX Kinect led to significant increases in energy expenditure, heart rate, and metabolic equivalents (METs) from initial to post-training and during transfer-testing, indicating effective physical engagement.

Participants also showed improved game proficiency over time, suggesting that exer-games can enhance motor learning and fitness benefits, although the overall level of physical exertion remained moderate after training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological and psychophysiological responses to an exer-game training protocol. Bronner, S., Pinsker, R., Naik, R., et al.[2017]

Active virtual reality games (AVRGs) can significantly elevate heart rate and oxygen consumption, with 'Thrill of the Fight' classified as vigorous intensity, while 'Holopoint' is moderate, and 'Audioshield' is light intensity based on metabolic equivalents (METs) and %VO2 reserve.

Despite the significant increases in VO2 during gameplay, participants rated the perceived exertion (RPE) lower than expected, suggesting that AVRGs may provide a fun way to exercise while still achieving substantial energy expenditure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Cost and Exercise Intensity During Active Virtual Reality Gaming. Gomez, DH., Bagley, JR., Bolter, N., et al.[2019]

Head-mounted displays for virtual reality (HMD-VR) are being explored as a promising tool in adult physical rehabilitation, showing potential for use in various conditions like stroke and Parkinson's disease, based on a review of 21 experimental studies.

While HMD-VR has demonstrated various applications in rehabilitation, there is a need for higher quality clinical studies to better understand its impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of Head-Mounted Displays for Virtual Reality in Adult Physical Rehabilitation: A Scoping Review. Saldana, D., Neureither, M., Schmiesing, A., et al.[2023]

Using handheld weights (HHWs) while playing the active virtual reality game Beat Saber significantly increased exercise intensity, raising participants' heart rates from a low level (63.7% HRmax) to a moderate level (67.1% HRmax), which is beneficial for health.

Participants reported that the 0.5 kg HHWs did not cause discomfort during gameplay, suggesting that this method is a simple and effective way to enhance physical activity in virtual gaming without negatively impacting user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Handheld Weights as an Effective and Comfortable Way To Increase Exercise Intensity of Physical Activity in Virtual Reality: Empirical Study. Polechoński, J., Zwierzchowska, A., Makioła, Ł., et al.[2022]

Involving end users, such as therapists and rehabilitation clients, in the research and implementation of virtual reality (VR) and active video games (AVGs) can significantly improve the alignment of these technologies with their needs, potentially increasing clinical uptake.

The authors identified common benefits from user engagement, including enhanced buy-in from therapists and better technology integration, while also noting challenges in balancing technology capabilities with practical rehabilitation goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-user involvement in rehabilitation virtual reality implementation research. Proffitt, R., Glegg, S., Levac, D., et al.[2022]

In a study involving 41 participants aged 6 to 80, physical therapy supplemented with virtual reality led to significantly more movement (1120.88 m) compared to traditional physical therapy alone (672.65 m), indicating enhanced engagement and effectiveness of the virtual reality approach.

Both patients and physical therapists reported satisfaction with the virtual reality-enhanced therapy, suggesting it is a promising tool for improving physical therapy outcomes without increasing perceived exertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Augments Movement During Physical Therapy: A Pragmatic Randomized Trial. Hemphill, S., Rodriguez, S., Wang, E., et al.[2023]

Virtual and augmented reality environments are being effectively used for rehabilitation, helping individuals with various impairments, such as balance and attention, especially in children with brain injuries.

The shift from commercial gaming systems to specialized rehabilitation technologies indicates a growing trend in using advanced virtual reality and motion tracking to enhance therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Rehabilitation with Children: Challenges for Clinical Adoption [From the Field]. Glegg, S.[2018]

The study involving 24 older women (average age 70.5 years) demonstrated that a combined pelvic floor muscle exercises and virtual reality rehabilitation (PFM/VRR) program is feasible, with high participation and adherence rates (91% and 92% respectively).

Post-treatment results showed significant improvements in urinary incontinence symptoms and quality of life, with 91% of participants reporting high satisfaction with the program, indicating its potential as an effective treatment option for mixed urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. Elliott, V., de Bruin, ED., Dumoulin, C.[2019]

Participants reported higher enjoyment levels during high-intensity interval training (HIIT) when using virtual-reality (VR) exergaming in track mode compared to standard ergometry, indicating that VR can enhance the exercise experience.

While mean power output did not significantly differ between track and blank modes, it was notably higher in track mode compared to ghost mode and hard mode, suggesting that racing against one's previous performance (ghost mode) can effectively increase exercise intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual-reality exergaming improves performance during high-intensity interval training. Farrow, M., Lutteroth, C., Rouse, PC., et al.[2019]

Participants using immersive virtual reality (IVR) for resistance training enjoyed their workouts more and spent 14 minutes less per session compared to the self-directed control group, indicating higher engagement and efficiency.

The IVR group showed significantly greater improvements in muscular strength, endurance, peak leg power, body fat percentage, and cardiovascular health markers compared to the control group, suggesting that IVR exergaming is an effective exercise modality for enhancing fitness and health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of an Immersive Virtual Reality Exergame Incorporating an Adaptive Cable Resistance System on Fitness and Cardiometabolic Measures: A 12-Week Randomized Controlled Trial. Mologne, MS., Hu, J., Carrillo, E., et al.[2023]

The study found that the active VR game 'Hot Squat' (HS) achieved moderate physical activity intensity, significantly higher than other games like 'Beat Saber' (BS) and 'Holopoint' (HP), indicating its potential for effective exercise in young adults.

While 'Hot Squat' elicited the highest physical activity levels, 'Beat Saber' and 'Holopoint' were rated as more enjoyable, suggesting that games requiring less exertion may be more appealing for sustained engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Intensity, Perceived Exertion, and Enjoyment During Head-Mounted Display Virtual Reality Games. Evans, E., Naugle, KE., Kaleth, AS., et al.[2021]

The mobile game-based VR rehabilitation program (MoU-Rehab) significantly improved upper extremity function in stroke patients compared to conventional therapy, as measured by the Fugl-Meyer Assessment and other metrics.

The program was well-tolerated with no adverse effects reported, and patients expressed high satisfaction, indicating its feasibility as a rehabilitation tool for upper limb recovery after ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Choi, YH., Ku, J., Lim, H., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05563805

Exploring Virtual Reality Adventure Training Exergaming To examine the effects of an 8-week V-RATE intervention on mental health outcomes (i.e., depression, anxiety, posttraumatic stress, cognitive function, health- ...

2. trialx.com trialx.com/clinical-trials/listings/279976/exploring-virtual-reality-adventure-training-exergaming/

Exploring Virtual Reality Adventure Training Exergaming To examine the effects of an 8-week V-RATE intervention on mental health outcomes (i.e., depression, anxiety, posttraumatic stress, cognitive ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11532461/

Evaluating the effectiveness of virtual reality-based therapy as ... Virtual reality (VR)-based therapy has demonstrated potential in enhancing upper and lower limb functions, postural control, and balance.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352914821000526

Effectiveness of virtual reality-based exercise therapy in ... This review provides evidence for the potential effectiveness of virtual reality-based exercise therapy for the improvement of rehabilitation outcomes.

5. researchprotocols.org researchprotocols.org/2022/6/e32955/

Immersive Virtual Reality Exergames to Promote the Well ... This pilot study will provide important information on the feasibility, acceptability, and usability of a custom-made VR exergaming intervention to promote ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12441291/

Benefits of Exergaming Regarding to Conventional Physical ... This systematic review and meta-analysis evaluated how exergaming (EXG) compares with various conventional physical therapies in improving ...

7. trialstoday.org trialstoday.org/trial/NCT05563805

Exploring Virtual Reality Adventure Training Exergaming The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on women ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2211034825005097

Evaluating the impact of two exergaming systems ... Virtual Reality-Based Therapy Improves Fatigue, Impact, and Quality of Life in Patients with Multiple Sclerosis. A Systematic Review with a ...