Remote Game-based Exercise Program for Cognitive and Motor Function Improvement

Study Overview
=================
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. 110 participants will be randomly assigned to either the intervention or control group, both undergoing a 12-week home exercise program for 30 minutes twice weekly. The intervention group will complete sessions remotely using Tele-exergame, while the control group will participate in home-based exercise without technology.

Official Title
-----------------
Tele-exergame: Remotely-supervised Exercise Platform for Improving Cognition and Motor Function Using Telemedicine

Conditions
-----------------
Mild Cognitive Impairment, Dementia, Cognitive Impairment, Memory Loss

Intervention / Treatment
-----------------
* Device: Tele-Exergame Platform
* Device: No Tele-Exergame Platform


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote Exercise with tele-exergame<br>Subjects will perform exercises remotely twice a week with tele-exergaming platform. | Device: Tele-Exergame Platform<br>* Subjects will perform exercises remotely twice a week with tele-exergaming platform.<br>|
| Sham Comparator: home-based exercise without technology<br>Subjects will perform exercises at home without tele-exergaming platform twice a week. | Device: No Tele-Exergame Platform<br>* Subjects will perform exercises in the home exercise twice a week without tele-exergaming platform.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tele-exercise, exergame, tele-rehabilitation, Telehealth, telemedicine, virtual reality