Virtual Reality Treadmill Training for Aging

(V-TARGET Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Arlington

Disqualifiers: Limited mobility, Orthopedic injury, Cardiovascular issues, Motor/cognitive disorders, others

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

Compensation: Varies

Number of Visits: 11

Duration: 5 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Age-associated motor and cognitive deficits increase the risk of falls, a major cause of morbidity and mortality. Emerging evidence suggests that inflammatory mediators lead to impaired functional capacity and frailty in the elderly and suggests that immune system mediated inflammation in the brain play an important role in cognitive decline. Substantial literature has also demonstrated that age-targeted physical activity training are promising strategies for promoting the motor-cognitive process across the adult lifespan. Recently, the virtual reality (VR) application has been implemented in the neuropsychological rehabilitation settings suggesting that the VR-infused daily living activities may benefit the transfer of intervention outcomes and to promote autonomy in function of daily living such as cooking or grocery shopping. However, it remains unclear the effect of the VR-based exercise intervention (motor-cognitive impact) on older adults' cognitive function and fall prevention. The literature suggests that the similarity of VR exercises with real life activities may improve generalizability by extending the transfer of gains of training to everyday living and promote some aspects of quality of life in older adults. It is also unclear to what extent these aging-associated motor- cognitive changes may be affected by VR rehab games and whether systemic- and neuro-inflammation is ameliorated by this novel intervention in older adults. This purpose of this study is to design and implement a Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes (V-TARGET) intervention, focusing on adults (aged up to 75 years old). The study will compare the effects of V-TARGET intervention (self-paced treadmill-simulator exercise with VR rehab games) against a control group on motor-cognitive function, health-related quality of life (HRQOL), circulating inflammatory markers and cerebral/peripheral blood flow through this 5-week intervention (2 times/week, 30-minutes/session, 10 sessions total).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the V-TARGET treatment for aging?

Research shows that combining virtual reality with treadmill training can improve walking and balance in people with impairments. Additionally, virtual reality-based exercise programs have been found to enhance muscle strength and balance in older adults, suggesting potential benefits for aging individuals. ^{1 2 3 4 5}

Is virtual reality treadmill training safe for older adults?

Research on virtual reality exercise programs, including immersive virtual reality (IVR) exergames, shows they are generally safe for older adults, with no reported adverse effects such as simulator sickness. Studies have demonstrated good usability and positive experiences, suggesting that these programs are a safe option for physical activity in older populations. ^{2 3 6 7 8}

How is the V-TARGET treatment different from other treatments for aging-related walking and balance issues?

The V-TARGET treatment is unique because it combines virtual reality with treadmill training, which not only helps improve walking and balance but also enhances cognitive engagement by mimicking real-world walking conditions. This approach allows for more effective rehabilitation by simulating over ground walking, unlike traditional treadmill training that uses a constant speed. ^{1 2 9 10 11}

Research Team

Xiangli Gu

Principal Investigator

University of Texas at Arlington

Eligibility Criteria

This trial is for adults up to 75 years old who are interested in a study on how virtual reality-infused treadmill training can affect aging-related outcomes like motor-cognitive function and quality of life. Participants should be able to commit to a 5-week program with sessions twice a week.

Inclusion Criteria

I am 75 years old or younger.

English speaking

I can walk on my own without needing help from devices.

Exclusion Criteria

I have joint problems that stop me from moving freely.

I have a current injury to my bones or joints.

I do not have heart problems that stop me from joining or being active.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 5-week V-TARGET intervention with VR-infused treadmill training, consisting of 10 sessions (2 times/week, 30 minutes/session)

5 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1-month post-intervention

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• V-TARGET intervention

Trial Overview The V-TARGET intervention, which combines self-paced treadmill exercises with VR rehab games, is being tested against regular activities (control group) for its impact on physical and cognitive functions, overall well-being, inflammation levels in the body, and blood flow in the brain and body.

Participant Groups

Group I: V-TARGET intervention group Experimental Treatment 1 Intervention

All participants in the V-TARGET intervention group will exercise on the Virtuix Omni 360-degree self-paced, non-powered treadmill-simulator in the lab for 5-weeks (2 days/week, 30 minutes/session, 10 sessions total. The treadmill-simulator is a first-of-its-kind motion platform on which an individual can walk and run at a self-paced speed in 360 degrees (i.e., forwards, sideways and backwards) without risk of falling or colliding with other people. The V-TARGET intervention group will self-pace their locomotor action (walking/running) on the Omni treadmill-simulator while they wear the Pico Neo 2 head-mounted display (HMD) headset and use the Neuro Rehab VR XR Therapy system to experience daily activity exercises/games, including Retail Therapy, Explore (gait training), Lunchtime Adventure, and Nature Walk.

Group II: The waitlist control group Active Control 1 Intervention

The control group will not do any VR exercise but will only complete the pre-post and 1-month follow-up assessment upon signing up the study.

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials

48

Recruited

7,300+

Findings from Research

Combining virtual reality with treadmill training significantly improves walking speed, step length, and balance in patients with walking and balance impairments, based on a review of 16 randomized controlled trials involving 829 participants.

This augmented training approach also enhances functional mobility and balance confidence, demonstrating its clinical significance over traditional treadmill-only training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality augments effectiveness of treadmill walking training in patients with walking and balance impairments: A systematic review and meta-analysis of randomized controlled trials. Hao, J., Buster, TW., Cesar, GM., et al.[2023]

Using a VirZoom VR exercise bike (vBike) led to significantly higher physical activity levels, measured by pedal revolution counts, compared to both an exergaming bike (eBike) and a traditional stationary bike (tBike) in a study with 48 college students.

Participants reported lower perceived exertion while using the vBike compared to the tBike, suggesting that VR exercise may provide a more enjoyable and less intense workout experience, which could encourage more people to engage in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Effects of Virtual Reality Exercise Biking on College Students' Physical Responses. Zeng, N., Liu, W., Pope, ZC., et al.[2023]

Non-immersive virtual reality (VR) balance exercises significantly improve overall balance function in older adults, with a moderate to large effect size based on a meta-analysis of 25 studies.

The presence of avatars and knowledge of performance (KP) feedback during VR exercises enhances their effectiveness, particularly for static balance compared to gait improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of non-immersive virtual reality exercises for balance and gait improvement in older adults: A meta-analysis. Park, JH., Jeon, HS., Kim, JH., et al.[2023]

The individualized treadmill controller for user-driven walking (UDW) allows for gait biomechanics similar to traditional treadmill-driven walking (TDW), making it a safe and effective option for gait training in controlled environments.

UDW enhances cognitive engagement during virtual reality applications, potentially improving motor learning outcomes compared to standard treadmill training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel walking speed estimation scheme and its application to treadmill control for gait rehabilitation. Yoon, J., Park, HS., Damiano, DL.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Virtual reality augments effectiveness of treadmill walking training in patients with walking and balance impairments: A systematic review and meta-analysis of randomized controlled trials. [2023]

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

Unsupervised virtual reality-based exercise program improves hip muscle strength and balance control in older adults: a pilot study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Effects of an Immersive Virtual Reality Exergame Program on Physical Functions in Institutionalized Older Adults: A Randomized Clinical Trial. [2023]

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

Attentional Demand of a Virtual Reality-Based Reaching Task in Nondisabled Older Adults. [2020]

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

Developing Home-Based Virtual Reality Therapy Interventions. [2022]

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

Acute Effects of Virtual Reality Exercise Biking on College Students' Physical Responses. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality as a Novel Physical Therapy Approach for Nonagenarians: Usability and Effects on Balance Outcomes of a Game-Based Exercise Program. [2022]

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

Muscle Activity During Immersive Virtual Reality Exergaming Incorporating an Adaptive Cable Resistance System. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of non-immersive virtual reality exercises for balance and gait improvement in older adults: A meta-analysis. [2023]

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

Acute effects of virtual reality treadmill training on gait and cognition in older adults: A randomized controlled trial. [2022]

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

A novel walking speed estimation scheme and its application to treadmill control for gait rehabilitation. [2021]