Remote Game-based Exercise Program for Cognitive and Motor Function Improvement
- Conditions
- DementiaMild Cognitive ImpairmentCognitive ImpairmentMemory Loss
- Interventions
- Device: No Tele-Exergame PlatformDevice: Tele-Exergame Platform
- Registration Number
- NCT05235113
- Lead Sponsor
- University of California, Los Angeles
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description home-based exercise without technology No Tele-Exergame Platform Subjects will perform exercises at home without tele-exergaming platform twice a week. Remote Exercise with tele-exergame Tele-Exergame Platform Subjects will perform exercises remotely twice a week with tele-exergaming platform.
- Primary Outcome Measures
Name Time Method Change in Balance Baseline and 12 weeks Change in balance from baseline to 12 weeks will be measured. Balance will be assessed by measuring center of mass sway. The investigator will use a validated wearable platform (BalanSen) to measure body sway.
Change in Cognitive Function Baseline and 12 weeks Changes from baseline in cognitive function at 12 weeks. Cognitive performance will be assessed using Montreal Cognitive Assessment (MoCA). Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
- Secondary Outcome Measures
Name Time Method Change in Physical Activity Baseline and 12 weeks Changes in physical activity from baseline to 12 weeks will be assessed. Physical activity will be quantified by measuring number of taken steps per day and will be measured using a validated wearable sensor named PAMSys. Monitoring of physical activity will be done during 48h baseline and 48 hour at 12 weeks.
Change in Quality of Life Baseline and 12 weeks Quality of life will be assessed using a validated questionnaire, called PROMIS Global-10.
The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.change in depression Baseline and 12 weeks Changes in depression from baseline to 12 weeks will be assessed. Depression will be quantified by the Center for Epidemiologic Studies Depression Scale (CES-D) at baseline and 12 weeks. The CES-D consists of 20 items, and each item is scored on a scale of 0 to 3, with 0 representing "Rarely or none of the time" and 3 representing "Most or all of the time." The total score for the CES-D ranges from 0 to 60, with higher scores indicating a greater severity of depressive symptoms.
A score of 16 or higher is often considered as a cutoff point for identifying individuals who may be at risk for clinical depression. However, it is important to note that the CES-D is a screening tool, not a diagnostic tool, and a higher score should prompt further evaluation by a mental health professional.Change in Fear of Falling Baseline and 12 weeks Changes in Fear of falling will be assessed by Short Falls Efficacy Scale International (FES I) questionnaire at 12 weeks and will be compared to baseline measurements. Scores range from 16 to 64, the higher the score the more concerned the subject is with falling.
Change in Gait speed Baseline and 12 weeks Change from baseline in Gait speed at 12 weeks. Gait speed will be measured using a validated wearable platform (LEGSys) during habitual walking speed.
Trial Locations
- Locations (2)
UCLA
šŗšøLos Angeles, California, United States
Baylor College of Medicine
šŗšøHouston, Texas, United States