Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes
ConditionAdult ALL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas at Arlington
About 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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
adults aged up to 75 years old
able to walk independently, without use of an assistive device
English speaking
Disqualifiers
self-disclosed limited mobility in joint(s) due to arthritis or other condition that would prevent participation
any ongoing orthopedic injury
cardiac surgery or any ongoing cardiovascular issues preventing participation or physical activity.
motor/cognitive disorders (Alzheimer's disease, Parkinson's disease, dementia, etc.)
Trial design
Design model
Parallel
Treatments tested in this trial
V-TARGET intervention
DeviceV-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: V-TARGET intervention groupExperimental treatment 1 intervention
Group B: The waitlist control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Motor Function
The Tinetti scale measures motor function; the total score ranges from 0- 28: a total score of less than or equal to 18 indicates high risk of falling; score range 19-23 indicates moderate risk of falling; and more than or equal to 24 indicates low risk of falling.
Time frame
Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.2
Motor skill
The Bruininks Motor Ability Test (BMAT) is a standardized test of gross and fine motor skills for adults and older. It assesses fine motor integration, manual dexterity, coordination, balance and mobility, and strength and flexibility. Each subtest score is converted into scaled scores based on normative data. The total BMAT score is derived by summing the scores from each domain, which can then be compared to age-based norms. Higher scores indicate better motor abilities, while lower scores may suggest areas that could benefit from intervention or support.
Time frame
Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.3
Cognitive function: Multitasking test (MTT)
Cognitive function is assessed with CANTAB (Cambridge Neuropsychological Test Automated Battery) using a handheld tablet (10 x 10-inch iPad). Multitasking test (MTT) is a test of the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Outcome measures include response latencies and error scores.
Time frame
Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.4
Cognitive function: The spatial working memory (SWM) test
Cognitive function is assessed with CANTAB (Cambridge Neuropsychological Test Automated Battery) using a handheld tablet (10 x 10-inch iPad). The spatial working memory (SWM) test requires retention and manipulation of visuospatial information, and provides a measure of strategy as well as working memory errors. Outcome measures include errors and strategies.
Time frame
Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.Secondary outcomes
1
Circulating inflammatory markers: percentage of T cells expressing CXCR3
Following a blood draw (\~5ml or 1 teaspoon), T cell CXCR3 (the receptor for CXCL10) expression will be assessed by the standard Flow cytometry and calculated in %.
Time frame
Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.2
Circulating inflammatory markers: interferon-gamma (IFN-γ)
Following a blood draw (\~5ml or 1 teaspoon), interferon-gamma (IFN-γ) is assessed by enzyme-linked immunoassay (ELISA) and calculated in pg/ml.
Time frame
Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.3
Circulating inflammatory markers: Circulating CXCL10
Following a blood draw (\~5ml or 1 teaspoon), Circulating CXCL10 is assessed by enzyme-linked immunoassay (ELISA) and calculated in pg/ml
Time frame
Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.4
Cerebrovascular Health: Heart Rate
Heart Rate (beats per minute): Standard heart rate measurement using electrocardiogram
Time frame
Baseline & immediately following the intervention & and again at 1-month following completion of the intervention.Sponsors and contacts
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Source ClinicalTrials.gov