Clinical trial NCT06727942: Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes
Official title: Toward Healthy Living: Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adult ALL
Keywords: Virtual-Reality
Fall Risk Invention
Physical Activity
Neuromotor Rehabilitation
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into two groups: the intervention group and the control group. All participants 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 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. 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Motor Function
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Motor skill
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Cognitive function: Multitasking test (MTT)
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Cognitive function: The spatial working memory (SWM) test
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
Secondary outcomes:
measure: Circulating inflammatory markers: percentage of T cells expressing CXCR3
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Circulating inflammatory markers: interferon-gamma (IFN-γ)
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Circulating inflammatory markers: Circulating CXCL10
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Cerebrovascular Health: Heart Rate
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Cerebrovascular Health: Systolic arterial blood pressure in the brachial artery (mmHg)
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Cerebrovascular Health: Diastolic arterial blood pressure in the brachial artery (mmHg)
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Cerebrovascular Health: mean arterial blood pressure in the brachial artery (mmHg)
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Cerebrovascular Health: Endothelial Function (% change of brachial artery diameter)
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Cerebrovascular Health: Cerebral blood velocity (centimeters / second)
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
measure: Health-related quality of life (HRQOL)
timeFrame: Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.
Other outcomes:
Locations:
city: Arlington
country: United States
facility: University of Texas at Arlington Movement & Physical Activity Epidemiology Laboratory
state: Texas
Study officials:
affiliation: University of Texas at Arlington
name: Xiangli Gu
role: PRINCIPAL_INVESTIGATOR
References: