Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes

NCT ID: NCT06727942

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2026-09-30

Brief Summary

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).

Detailed Description

A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed. The study will compare the effects of V-TARGET intervention (self-paced treadmill exercise augmented by VR rehab games) against an active-control paradigm (self-paced treadmill exercise without VR rehab games) on motor-cognitive function, health-related quality of life (HRQOL), and circulating inflammatory markers through a 5-week V-TARGET intervention (2 times/week, 30-minutes/session, total 10 sessions). Specifically,

Primary Aim 1: To examine the effects of a 5-week V-TARGET intervention on motor function (i.e., balance/mobility and rate of fall), cognitive function (i.e., working memory and executive function), and HRQOL among older adults.

It is hypothesized that after controlling for socio-demographic variables (i.e., age, gender, SES, body mass index [BMI]), and physical activity history, individuals in the V-TARGET group would exhibit more improvement in the motor and cognitive function and better HRQOL after the intervention compared to individuals in the active control group. It is hypothesized that gains made by the experimental group at post-treatment would be maintained or enhanced at the 1-month follow-up.

Secondary Aim 2: To determine whether a 5-week V-TARGET intervention alters circulating inflammatory markers in older adults. Circulating levels of interferon (IFN)-γ, CXCL10, T cell IFN-γ production and cell surface expression of CXCR3 (the receptor for CXCL10) will be measured .

It is hypothesized that V-TARGET intervention will result in downregulation of the T cell/IFN-γ/CXCL10 inflammatory cascade and that these changes represent a potential biological mechanism by which the V-TARGET intervention improves motor-cognitive function in older adults with high risk of fall. It is hypothesized that gains made by the experimental group at post-treatment would be maintained or enhanced at the 1-month follow-up.

Secondary Aim 3: To examine the effects of a 5-week V-TARGET intervention on Cerebrovascular Health among older adults.

It is hypothesized that after controlling for socio-demographic variables (i.e., age, gender, SES, body mass index [BMI]), and physical activity history, individuals in the V-TARGET group would exhibit more improvement in the Cerebrovascular Health after the intervention compared to individuals in the active control group. It is hypothesized that gains made by the experimental group at post-treatment would be maintained or enhanced at the 1-month follow-up.

Conditions

Adult ALL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

V-TARGET intervention group

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 Type: EXPERIMENTAL

V-TARGET intervention

Intervention Type: DEVICE

V-TARGET intervention will be delivered through a 360 degree self-paced treadmill in a university clinical laboratory for 5-weeks (2 days/week, 30 minutes/session) with total 10 sessions. The treadmill is the first-of-kind motion platform that an individual can walk and run at self-paced speed in 360 degree (i.e., forwards, sideways and backwards) without risk of falling or colliding with other people. During the V-TARGET intervention, participants will self-pace their locomotor action (walking/running) while they wear the HTC vivo headset and experience daily exercises/games augmented by the VR Therapy System. Therapy System is a library of VR exercises/games targeted on neurological rehabilitation, balance improvement training as well as cognitive therapy suited for variety of conditions, and includes various daily living simulation activities such as Retail Shopping, Gait Training, Cafeteria Experience, and Nature Walk.

The waitlist control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

V-TARGET intervention

V-TARGET intervention will be delivered through a 360 degree self-paced treadmill in a university clinical laboratory for 5-weeks (2 days/week, 30 minutes/session) with total 10 sessions. The treadmill is the first-of-kind motion platform that an individual can walk and run at self-paced speed in 360 degree (i.e., forwards, sideways and backwards) without risk of falling or colliding with other people. During the V-TARGET intervention, participants will self-pace their locomotor action (walking/running) while they wear the HTC vivo headset and experience daily exercises/games augmented by the VR Therapy System. Therapy System is a library of VR exercises/games targeted on neurological rehabilitation, balance improvement training as well as cognitive therapy suited for variety of conditions, and includes various daily living simulation activities such as Retail Shopping, Gait Training, Cafeteria Experience, and Nature Walk.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. adults aged up to 75 years old

2. able to walk independently, without use of an assistive device

3. English speaking

Exclusion Criteria

1. self-disclosed limited mobility in joint(s) due to arthritis or other condition that would prevent participation

2. any ongoing orthopedic injury

3. cardiac surgery or any ongoing cardiovascular issues preventing participation or physical activity.

4. motor/cognitive disorders (Alzheimer's disease, Parkinson's disease, dementia, etc.)

5. use of a wheelchair

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas at Arlington

OTHER

Sponsor Role: lead

Responsible Party

Xiangli

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiangli Gu

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Arlington

Locations

University of Texas at Arlington Movement & Physical Activity Epidemiology Laboratory

Arlington, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Associate Professor

Role: CONTACT

xiangli.gu@uta.edu

817-272-3318

Professor

Role: CONTACT

matthew.brothers@uta.edu

817-272-3156

Facility Contacts

Kinesiology Administrator

Role: primary

cindyks@uta.edu

817-272-3109

MPAE Lab manager

Role: backup

caifang.wu@uta.edu

817-272-3318

Related Links

https://mpaelab.uta.edu/research/v-rate/

Virtual Reality Rehab-Therapy on Neuromotor Function and Cardiovascular Health

Other Identifiers

2021-0678

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0678

Identifier Type: -

Identifier Source: org_study_id