Wii-Fit For Balance And Gait In Elderly Veterans

Postural Balance Clinical Trial

Official title:

Wii-Fit For Balance And Gait In Elderly Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190045
• Other study ID #: 404039
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: Central Arkansas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Unsteady
• Postural Balance

Intervention

Other:
• Wii-Fit exercises
Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks
• Cognitive remediation exercises
Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks

Locations

Country	Name	City	State
United States	Central Arkansas Veterans Healthcare System (3J/NLR)	North Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Central Arkansas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life (SF-36)		8 weeks
Secondary	Functional Status Measures		8 weeks
Secondary	Activities Specific Balance Confidence Scale		8 weeks
Secondary	Modified Mini- Mental Exam		8 weeks