Overview

This trial is active, not recruiting.

Conditions gait, unsteady, postural balance
Treatments wii-fit exercises, cognitive remediation exercises
Sponsor Central Arkansas Veterans Healthcare System
Start date September 2013
End date September 2015
Trial size 29 participants
Trial identifier NCT02190045, 404039

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
wii-fit exercises
Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks
(Placebo Comparator)
Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
cognitive remediation exercises
Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks

Primary Outcomes

Measure
Berg Balance Scale
time frame: 8 weeks

Secondary Outcomes

Measure
Quality of Life (SF-36)
time frame: 8 weeks
Functional status measures
time frame: 8 weeks
Activities Specific Balance Confidence Scale
time frame: 8 weeks
Modified Mini- Mental exam
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 60 years up to 95 years old.

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.

Additional Information

Official title Wii-Fit For Balance And Gait In Elderly Veterans
Principal investigator Kalpana Padala, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Central Arkansas Veterans Healthcare System.