Exploring Virtual Reality Adventure Training Exergaming

(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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that null is an effective treatment?

The available research shows that virtual reality treatments, like null, can be effective because they make therapy more engaging and enjoyable, which helps patients stick with their treatment. For example, virtual reality has been used successfully to help people recover movement after a stroke by making exercises more fun and motivating. It has also been used to help older women with urinary issues by keeping them motivated to follow through with their exercises. In general, virtual reality can make physical therapy more effective by increasing the amount of movement patients do during their sessions. This suggests that null could be a promising option for making therapy more effective and enjoyable. ^{1 2 3 4 5}

What safety data exists for Virtual Reality Adventure Therapy Exergaming?

The provided research does not directly address safety data for Virtual Reality Adventure Therapy Exergaming (V-RATE). The studies focus on physical activity intensity, enjoyment, metabolic cost, exercise intensity, and user involvement in virtual reality games, but do not specifically mention safety outcomes or adverse effects related to V-RATE or similar treatments. ^{2 6 7 8 9}

Is Virtual Reality Adventure Therapy Exergaming (V-RATE) a promising treatment?

Yes, V-RATE is promising because it makes exercise more enjoyable and engaging, which can help people stay active. It also offers a fun way to improve fitness and motor skills, making it a good option for physical rehabilitation. ^{6 7 10 11 12}

Eligibility Criteria

Inclusion Criteria

You have normal vision without colorblindness.

You are female.

You are female.

Timeline

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)

Treatment Details

Interventions

• Virtual Reality Adventure Therapy Exergaming (V-RATE)

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. [2019]

2. England pubmed.ncbi.nlm.nih.gov

End-user involvement in rehabilitation virtual reality implementation research. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Augments Movement During Physical Therapy: A Pragmatic Randomized Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Physical Activity Intensity, Perceived Exertion, and Enjoyment During Head-Mounted Display Virtual Reality Games. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Metabolic Cost and Exercise Intensity During Active Virtual Reality Gaming. [2019]

8. Switzerland 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. [2023]

9. Canada 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. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Physiological and psychophysiological responses to an exer-game training protocol. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Virtual-reality exergaming improves performance during high-intensity interval training. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Applications of Head-Mounted Displays for Virtual Reality in Adult Physical Rehabilitation: A Scoping Review. [2023]