Clinical trial NCT05235113: Remote Game-based Exercise Program for Cognitive and Motor Function Improvement
Official title: Tele-exergame: Remotely-supervised Exercise Platform for Improving Cognition and Motor Function Using Telemedicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia
Cognitive Impairment
Memory Loss
Keywords: tele-exercise
exergame
tele-rehabilitation
Telehealth
telemedicine
virtual reality
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: BioSensics
name: National Institute on Aging (NIA)
First posted: 2022-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will perform leg and foot exercises twice a week. The IG will use the Tele-exergaming platform, and the CG will do the exercises without the platform.
Primary purpose: SUPPORTIVE_CARE

Brief summary: As our population ages, more older adults face motor-cognitive declines, increasing their risk of falls and fear of falling. Exercise is an effective way to maintain cognitive function, as supported by recent studies. However, those with poor motor and cognitive abilities often struggle to visit rehabilitation centers, leading to high dropout rates and low adherence to unsupervised programs. A remote exercise program tailored for individuals with cognitive impairments is urgently needed to preserve cognitive function, promote independent living, and reduce related costs. Researchers aim to develop an in-home system for adults with mild cognitive issues or dementia, designed to improve balance and cognition while being remotely supervised through telemedicine.

Detailed description: This study aims to develop and validate a remote exercise intervention for individuals at risk of or experiencing dementia using a wearable sensor-enabled platform, called Tele-Exergame. This approach could preserve cognitive function, promote independent living, reduce costs related to cognitive-motor decline, and advance remote technology use for screening cognitive and motor performance in older adults. The findings are crucial for healthcare providers, clinicians, seniors, and caregivers.

100 participants will be randomly assigned to either the intervention or control group, both undergoing a 12-week daily home exercise program for at least cumulative active exercise of 30 minutes per week twice weekly. The intervention group will complete sessions remotely using Tele-exergame, while the control group will participate in home-based exercise without technology.

Eligibility criteria: Inclusion Criteria:

* Adults with diagnosed with dementia or cognitive impairment
* Living independently in a residential home with a caregiver/informant
* Able to walk at least 30 feet with or without assistance

Exclusion Criteria:

* Immobility or major mobility disorder or inability to engage safely in the proposed weight-bearing exercise program
* Diagnosed with severe cognitive impairment (MoCA score \< 16)
* Subjects with major hearing/visual impairment

Primary outcomes:
measure: Change in Balance
timeFrame: Baseline and 12 weeks
measure: Change in Cognitive Function
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline and 12 weeks
measure: Change in Quality of Life
timeFrame: Baseline and 12 weeks
measure: change in depression
timeFrame: Baseline and 12 weeks
measure: Change in Fear of Falling
timeFrame: Baseline and 12 weeks
measure: Change in Gait speed
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Supportive care acceptability
timeFrame: Baseline and 12 weeks
measure: Adherence
timeFrame: week 4, week 8, week 12
measure: intervention related dropout
timeFrame: week 4, week 8, week 12
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: Park C, Mishra RK, York MK, Enriquez A, Lindsay A, Barchard G, Vaziri A, Najafi B. Tele-Medicine Based and Self-Administered Interactive Exercise Program (Tele-Exergame) to Improve Cognition in Older Adults with Mild Cognitive Impairment or Dementia: A Feasibility, Acceptability, and Proof-of-Concept Study. Int J Environ Res Public Health. 2022 Dec 6;19(23):16361. doi: 10.3390/ijerph192316361.