Wii-Fit For Balance And Gait In Elderly Veterans

Study Overview
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Brief Summary
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Falls are a major public health problem. They are the leading cause of injuries and injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly. Despite the many proven benefits of exercise, many older adults in the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit as an exercise program.

Detailed Description
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Objectives/Rationale Falls are a major public health problem. They are the leading cause of injuries and injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly. Despite the many proven benefits of exercise, many older adults in the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit as an exercise program. Specific aims To establish the safety, feasibility, and efficacy of an 8-week Wii-Fit program to improve measures of balance, and gait in older adults, compared to a cognitive remediation program, Brain fitness. To compare the effect of an 8-week Wii-Fit program to Brain fitness program, on measures of biomechanical assessment, adherence, safety, physical activity, fear of fall, enjoyment, functional status, cognition and quality of life. Design 8-week, randomized, parallel group, active intervention study Methods Patients will be recruited via IRB approved flyers posted in various locations of the Little Rock and North Little Rock CAVHS campuses and via referrals from the CAVHS providers. Thirty elderly Veterans will be randomly assigned to Wii-Fit arm or Brain fitness arm. Both groups will participate in the intervention for approximately 45 minutes 3 days a week for 8 weeks. Outcome measures will be assessed at baseline, and approximately week 4 and after completion of week 8. Balance and gait will be assessed by Berg Balance Scale. Secondary outcome measures include biomechanical testing for gait and balance, Safety, Adherence, measures of functional status, cognition, quality of life, fear of falling, physical activity and physical activity enjoyment.

Official Title
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Wii-Fit For Balance And Gait In Elderly Veterans

Conditions
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Gait, Unsteady, Postural Balance

Intervention / Treatment
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* Other: Wii-Fit exercises
* Other: Cognitive remediation exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age ≥ 60 years Fall risk as measured by Berg Balance Scale (BBS) is ≤ 52 Normal cognition as measured by Mini Mental State Exam (MMSE ≥ 24) Able to consent Exclusion Criteria: Subjects using wheel chair or walkers for mobility Subjects with absolute contraindications per ACSM guidelines Any medical condition (per the relative contraindications per ACSM guidelines below) that in the opinion of the study physician is likely to compromise their ability to safely participate in the exercise program.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wii-Fit program<br>Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks | Other: Wii-Fit exercises<br>* Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks<br>|
| Placebo Comparator: Cognitive remediation program<br>Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks | Other: Cognitive remediation exercises<br>* Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from 0 (lowest level of function) to 4 (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (SF-36) |  | 8 weeks | 
| Functional Status Measures |  | 8 weeks | 
| Activities Specific Balance Confidence Scale |  | 8 weeks | 
| Modified Mini- Mental Exam |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance, gait, Wii-Fit