Clinical trial NCT02190045: Wii-Fit For Balance And Gait In Elderly Veterans
Official title: Wii-Fit For Balance And Gait In Elderly Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Unsteady
Postural Balance
Keywords: Balance
gait
Wii-Fit
Lead sponsor: Central Arkansas Veterans Healthcare System
Sponsor class: FED
First posted: 2014-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Quality of Life (SF-36)
timeFrame: 8 weeks
measure: Functional Status Measures
timeFrame: 8 weeks
measure: Activities Specific Balance Confidence Scale
timeFrame: 8 weeks
measure: Modified Mini- Mental Exam
timeFrame: 8 weeks
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System (3J/NLR)
state: Arkansas
Study officials:
affiliation: Central Arkansas Veterans Healthcare System
name: Kalpana Padala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Padala KP, Padala PR, Lensing SY, Dennis RA, Bopp MM, Parkes CM, Garrison MK, Dubbert PM, Roberson PK, Sullivan DH. Efficacy of Wii-Fit on Static and Dynamic Balance in Community Dwelling Older Veterans: A Randomized Controlled Pilot Trial. J Aging Res. 2017;2017:4653635. doi: 10.1155/2017/4653635. Epub 2017 Feb 5.