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Clinical Trials/NCT02190045
NCT02190045
Completed
N/A

Wii-Fit For Balance And Gait In Elderly Veterans

Central Arkansas Veterans Healthcare System1 site in 1 country30 target enrollmentSeptember 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gait, Unsteady
Sponsor
Central Arkansas Veterans Healthcare System
Enrollment
30
Locations
1
Primary Endpoint
Berg Balance Scale
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

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 1. 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. 2. 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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
December 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kalpana Padala, MD

Staff Physician

Central Arkansas Veterans Healthcare System

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Berg Balance Scale

Time Frame: 8 weeks

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.

Secondary Outcomes

  • Quality of Life (SF-36)(8 weeks)
  • Modified Mini- Mental Exam(8 weeks)
  • Functional Status Measures(8 weeks)
  • Activities Specific Balance Confidence Scale(8 weeks)

Study Sites (1)

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