Remote Game-based Exercise Program for Cognitive and Motor Function Improvement
Study Details
Study Description
Brief Summary
Rapid population aging is increasing the number of older adults who suffer from motor-cognitive declines and associated increases in fall risk and fear of falling. Effectiveness of exercise, as an effective intervention to preserve cognitive function, has been well established and supported by recent studies including systematic reviews and the investigators' previous work. But at the same time individuals with poor motor and cognitive performance generally cannot have regular visits to a rehabilitation center for face-to-face exercise, have highest drop out because of functional limitations, and have poorest adherence to unsupervised exercise programs. Therefore, designing a remote exercise intervention, tailor for those with cognitive impairment, is desperately needed and could make a significant impact in the field, including preserving cognitive function in people with MCI, promoting independent living, and reducing costs associated with consequence of cognitive-motor decline including falls and frailty. The investigators propose to develop an in-home exercise system for adults with mild cognitive impairment or mild dementia that is specifically designed to improve balance and cognition during distractive conditioning while the exercise is remotely supervised by a telemedicine interface.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This research study aims to help design and validate a novel technology to remotely provide exercise intervention for people at risk or with some level of dementia. In addition, the platform enables remote assessment of cognitive-motor performance via wearable sensors through playing a simple interactive game named iTMT. A remote exercise intervention tailored to those with cognitive impairments could make significant impact in preserving cognitive function in people with MCI, promoting independent living, and reducing costs associated with consequence of cognitive-motor decline including falls and frailty. This application could in addition further the knowledge in use and development of remote technology to screen cognitive and motor performance and promote independent living in older adults in particular for those who are suffering from cognitive impairment and dementia. Given the large and growing number of older people at risk of developing cognitive impairment and dementia, this knowledge would be important to health providers, clinicians, older people, and their caregivers.
100 subjects will be randomized into either intervention or control group. All recruited subjects will undergo to 12 weeks exercise program using the Exergaming platform described in the proposal, twice per week for approximately 30 minutes. The intervention group will be given the Exergaming system and will perform the 24 exercise sessions remotely. The control group will perform the exercise sessions in person under supervision with the Exergaming system.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Remote Exercise Subjects will perform exercises remotely twice a week with tele-exergaming platform. |
Device: Tele-Exergame Platform
Subjects will perform exercises remotely twice a week with tele-exergaming platform.
|
| Sham Comparator: In person Exercise Subjects will perform exercises in the clinic without tele-exergaming platform twice a week. |
Device: No Tele-Exergame Platform
Subjects will perform exercises in the clinic twice a week without tele-exergaming platform.
|
Outcome Measures
Primary Outcome Measures
- 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 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.
- 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.
- 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.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults with mild cognitive impairment or dementia
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Living independently in a residential home with a caregiver/informant
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Able to walk at least 30 feet with or without assistance
Exclusion Criteria:
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Immobility or major mobility disorder or inability to engage safely in the proposed weight-bearing exercise program
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Diagnosed with severe cognitive impairment (MoCA score < 20), other neurological conditions associated with cognitive impairment
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Subjects with major hearing/visual impairment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor College of Medicine | Houston | Texas | United States | 77498 |
Sponsors and Collaborators
- Baylor College of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-44913