Wii-fit for Activity, Balance and Gait in Assisted Living

Study Overview
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Brief Summary
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Falls in Alzheimer's Disease (AD) are common and lead to fractures, acute hospitalizations and increased rate of institutionalization. Poor balance and gait abnormalities, commonly associated with AD, are risk factors. Improving balance and gait abnormalities is critical in preventing these falls. Walking is the most commonly recommended home-based exercise program for elderly by primary care providers. However, it is difficult to engage patients with AD in long term exercise programs. Barriers include lack of motivation, poor engagement, and external factors such as the cost of physical therapy (PT). The use of readily available technology might bridge this gap by providing high level of engagement via use of multimedia at an affordable price. Wii-Fit is a Nintendo gaming console used for aerobics, strength training, and balance activities. It is a TV based self-directed activity where virtual trainers talk the user through the activity while tracking progress. Some skilled nursing facilities have started using the Wii-Fit as an adjunct to PT and note improvement in balance along with social benefits, but no systematic studies are done to generalize the findings. This study will compare changes in balance and daily living activities between a group receiving Wii-Fit training and another receiving a walking exercise program.

Detailed Description
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Purpose of the study: Falls in Alzheimer's Disease (AD) are common and lead to fractures, acute hospitalizations and increased rate of institutionalization. Poor balance and gait abnormalities, commonly associated with AD, are risk factors for falls. Improving balance and gait abnormalities is critical to prevent falls in AD. Exercise interventions improve gait and balance in elderly. Walking is the most commonly recommended home-based exercise program for elderly by primary care providers. However, it is difficult to engage patients with AD in long term exercise programs. Barriers to exercise programs include lack of motivation, poor engagement, and external factors such as the cost of physical therapy (PT). Use of readily available technology might bridge this gap by providing high level of engagement via use of multimedia at an affordable price. Wii-Fit is a Nintendo gaming console used for aerobics, strength training, and balance activities. This device includes a balance board that senses weight, movement and balance. Wii-Fit is a TV based self-directed activity not limited by the constraint of a therapist's presence. Virtual trainers talk the user through the activity while tracking progress. Furthermore, visual and auditory feedback improves engagement. Some skilled nursing facilities have started using the Wii-Fit as an adjunct to PT, and note improvement in balance along with social benefits but no systematic studies are done to generalize the findings. The investigators propose an 8 week prospective randomized study with the treatment group receiving the exercise program delivered by Wii-Fit system and the comparison arm receiving a walking exercise program.

Official Title
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Wii-fit for Activity, Balance and Gait in Assisted Living

Conditions
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Falls, Alzheimer's Disease

Intervention / Treatment
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* Other: Wii-Fit intervention
* Other: Walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 Alzheimer's Dementia, mild (MMSE ≥ 18) Residing in assisted living facility Presence of legal surrogate Exclusion Criteria: History of myocardial infarction, TIA or stroke in last 6 months Presence of serious mental illness impacting memory Active cancer except skin cancer Medical conditions likely to compromise survival (e.g. severe congestive heart failure) Severe sensory and musculoskeletal impairments Using wheel-chair

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wii-Fit Intervention<br>Intervention: Subjects in this arm participate in Wii-Fit exercises | Other: Wii-Fit intervention<br>* Half hour daily, 5 days a week for 8 weeks<br>* Other names: Exercise intervention;Other: Walking<br>* Half hour daily, five days a week for 8 weeks<br>* Other names: Exercise intervention;|
| Active Comparator: Walking Intervention<br>Intervention: Subjects in this arm participate in walking | Other: Walking<br>* Half hour daily, five days a week for 8 weeks<br>* Other names: Exercise intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Balance test | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of Daily Living | Daily functioning test | 8 weeks | 
| Instrumental Activities of Daily Living | Higher level of functioning assessment | 8 weeks | 
| Timed Up and Go | Functional performance test | 8 weeks | 
| Quality of Life-AD | Global quality of life measure | 8 weeks | 
| Mini Mental State Exam | Global cognitive screen | 8 weeks | 
| Actigraphy | Activity measure | 3 days before the intervention and 3 days during the intervention | 
| Trails A and B | Executive function measure | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wii-Fit, Assisted living, Alzheimer's dementia