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Wii-Fit For Balance And Gait In Elderly Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02190045
Recruitment Status : Completed
First Posted : July 15, 2014
Results First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Kalpana Padala, MD, Central Arkansas Veterans Healthcare System

Tracking Information
First Submitted Date  ICMJE July 11, 2014
First Posted Date  ICMJE July 15, 2014
Results First Submitted Date  ICMJE January 23, 2018
Results First Posted Date  ICMJE September 24, 2018
Last Update Posted Date September 24, 2018
Study Start Date  ICMJE September 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Berg Balance Scale [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT02190045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Wii-Fit For Balance And Gait In Elderly Veterans
Official Title  ICMJE Wii-Fit For Balance And Gait In Elderly Veterans
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gait, Unsteady
  • Postural Balance
Intervention  ICMJE
  • Other: Wii-Fit exercises
    Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks
  • Other: Cognitive remediation exercises
    Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks
Study Arms  ICMJE
  • Experimental: Wii-Fit program
    Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
    Intervention: Other: Wii-Fit exercises
  • Placebo Comparator: Cognitive remediation program
    Cognitive remediation exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
    Intervention: Other: Cognitive remediation exercises
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02190045
Other Study ID Numbers  ICMJE 404039
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kalpana Padala, MD, Central Arkansas Veterans Healthcare System
Study Sponsor  ICMJE Central Arkansas Veterans Healthcare System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kalpana Padala, MD Central Arkansas Veterans Healthcare System
PRS Account Central Arkansas Veterans Healthcare System
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP