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Wii-Fit For Balance And Gait In Elderly Veterans

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gait, Unsteady Postural Balance Other: Wii-Fit exercises Other: Cognitive remediation exercises Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wii-Fit For Balance And Gait In Elderly Veterans
Study Start Date : September 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Wii-Fit program
Wii-Fit exercises will be adminstered for 45 minutes 3 days a week for 8 weeks
 Other: Wii-Fit exercises
Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks
Placebo Comparator: Cognitive remediation program
Cognitive remediation exercises will be adminstered for 45 minutes 3 days a 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Quality of Life (SF-36) [ Time Frame: 8 weeks ]
  2. Functional Status Measures [ Time Frame: 8 weeks ]
  3. Activities Specific Balance Confidence Scale [ Time Frame: 8 weeks ]
  4. Modified Mini- Mental Exam [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190045


Locations
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United States, Arkansas
Central Arkansas Veterans Healthcare System (3J/NLR)
North Little Rock, Arkansas, United States, 72114
Sponsors and Collaborators
Central Arkansas Veterans Healthcare System
Investigators
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Principal Investigator: Kalpana Padala, MD Central Arkansas Veterans Healthcare System
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kalpana Padala, MD, Staff Physician, Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT02190045    
Other Study ID Numbers: 404039
First Posted: July 15, 2014    Key Record Dates
Results First Posted: September 24, 2018
Last Update Posted: September 24, 2018
Last Verified: January 2018
Keywords provided by Kalpana Padala, MD, Central Arkansas Veterans Healthcare System:
Balance
gait
Wii-Fit
Additional relevant MeSH terms:
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Gait Disorders, Neurologic
Neurologic Manifestations
Nervous System Diseases