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| ID | Type | Description | Link |
|---|---|---|---|
| R44AG067909 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| BioSensics | INDUSTRY |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Exercise with tele-exergame | Active Comparator | Subjects will perform exercises remotely twice a week with tele-exergaming platform. |
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| home-based exercise without technology | Sham Comparator | Subjects will perform exercises at home without tele-exergaming platform twice a week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-Exergame Platform | Device | Subjects will perform exercises remotely twice a week with tele-exergaming platform. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Balance | 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. | Baseline and 12 weeks |
| Change in Cognitive Function | 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity | 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Supportive care acceptability | To evaluate the acceptability of each in-home exercise program (both the tele-exergame and the non-tele-exergame exercises), we will employ a survey based on the Technology Acceptance Model. This survey will be administered to all participants, assessing their perceptions of ease of use, usefulness, technology anxiety, and intention to use. Each response will be rated on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree". This will be subsequently translated to a 0 to 4 scale for final evaluation, with higher scores indicating greater acceptability. The assessment will take place twice: initially at baseline, after the participants have tested the tele-exergame in the clinic for training purposes, and subsequently at the 12-week mark upon completion of the in-home exercise program. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| Baylor College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36498431 | Result | 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. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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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.
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| No Tele-Exergame Platform | Device | Subjects will perform exercises in the home exercise twice a week without tele-exergaming platform. |
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| Change in Quality of Life | 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. | Baseline and 12 weeks |
| change in depression | 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. | Baseline and 12 weeks |
| Change in Fear of Falling | 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. | Baseline and 12 weeks |
| Change in Gait speed | Change from baseline in Gait speed at 12 weeks. Gait speed will be measured using a validated wearable platform (LEGSys) during habitual walking speed. | Baseline and 12 weeks |
| Baseline and 12 weeks |
| Adherence | We will assess adherence to the prescribed in-home exercise program through the use of an exercise diary and phone interview on monthly basis. In the intervention group (IG), we will also objectively quantify adherence. Adherence will be defined by the frequency and duration of in-home exercises performed over a 12-week period. We will record and review adherence data on a monthly basis for three months. | week 4, week 8, week 12 |
| intervention related dropout | We will categorize participants as intervention-related dropouts if they miss exercises for four consecutive weeks, decide to discontinue the exercise program, or experience any exercise-related adverse events. However, if a participant drops out due to non-exercise related reasons (e.g., developing a condition that limits their ability to participate in the program, passing away, traveling, relocating), we will not consider this an intervention-related dropout. Intervention-related dropout will be calculated as a percentage of the total number of participants in each group. We will collect this data on a monthly basis. | week 4, week 8, week 12 |
| Houston |
| Texas |
| 77498 |
| United States |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |