Cognitive Impairment, Dementia, Memory Loss, Mild Cognitive Impairment
Conditions
Keywords
tele-exercise, exergame, tele-rehabilitation, Telehealth, telemedicine, virtual reality
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.
Interventions
DEVICETele-Exergame Platform
Subjects will perform exercises remotely twice a week with tele-exergaming platform.
DEVICENo Tele-Exergame Platform
Subjects will perform exercises in the home exercise twice a week without tele-exergaming platform.
Sponsors
University of California, Los Angeles
BioSensics
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed