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Wii-fit for Activity, Balance and Gait in Assisted Living

Primary Purpose

Falls, Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wii-Fit intervention
Walking
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Falls focused on measuring Wii-Fit, Assisted living, Alzheimer's dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 60
  • Alzheimer's Dementia, mild (MMSE ≥ 18)
  • Residing in assisted living facility
  • Presence of legal surrogate

Exclusion Criteria:

  • History of myocardial infarction, TIA or stroke in last 6 months
  • Presence of serious mental illness impacting memory
  • Active cancer except skin cancer
  • Medical conditions likely to compromise survival (e.g. severe congestive heart failure)
  • Severe sensory and musculoskeletal impairments
  • Using wheel-chair

Sites / Locations

  • Parson's House Assisted Living

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wii-Fit Intervention

Walking Intervention

Arm Description

Intervention: Subjects in this arm participate in Wii-Fit exercises

Intervention: Subjects in this arm participate in walking

Outcomes

Primary Outcome Measures

Berg Balance Scale
Balance test

Secondary Outcome Measures

Activities of Daily Living
Daily functioning test
Instrumental Activities of Daily Living
Higher level of functioning assessment
Timed Up and Go
Functional performance test
Quality of Life-AD
Global quality of life measure
Mini Mental State Exam
Global cognitive screen
Actigraphy
Activity measure
Trails A and B
Executive function measure

Full Information

First Posted
October 20, 2009
Last Updated
September 13, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT01000038
Brief Title
Wii-fit for Activity, Balance and Gait in Assisted Living
Official Title
Wii-fit for Activity, Balance and Gait in Assisted Living
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2009 (Actual)
Primary Completion Date
July 7, 2011 (Actual)
Study Completion Date
July 7, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Falls in Alzheimer's Disease (AD) are common and lead to fractures, acute hospitalizations and increased rate of institutionalization. Poor balance and gait abnormalities, commonly associated with AD, are risk factors. Improving balance and gait abnormalities is critical in preventing these falls. Walking is the most commonly recommended home-based exercise program for elderly by primary care providers. However, it is difficult to engage patients with AD in long term exercise programs. Barriers include lack of motivation, poor engagement, and external factors such as the cost of physical therapy (PT). The use of readily available technology might bridge this gap by providing high level of engagement via use of multimedia at an affordable price. Wii-Fit is a Nintendo gaming console used for aerobics, strength training, and balance activities. It is a TV based self-directed activity where virtual trainers talk the user through the activity while tracking progress. Some skilled nursing facilities have started using the Wii-Fit as an adjunct to PT and note improvement in balance along with social benefits, but no systematic studies are done to generalize the findings. This study will compare changes in balance and daily living activities between a group receiving Wii-Fit training and another receiving a walking exercise program.
Detailed Description
Purpose of the study: Falls in Alzheimer's Disease (AD) are common and lead to fractures, acute hospitalizations and increased rate of institutionalization. Poor balance and gait abnormalities, commonly associated with AD, are risk factors for falls. Improving balance and gait abnormalities is critical to prevent falls in AD. Exercise interventions improve gait and balance in elderly. Walking is the most commonly recommended home-based exercise program for elderly by primary care providers. However, it is difficult to engage patients with AD in long term exercise programs. Barriers to exercise programs include lack of motivation, poor engagement, and external factors such as the cost of physical therapy (PT). Use of readily available technology might bridge this gap by providing high level of engagement via use of multimedia at an affordable price. Wii-Fit is a Nintendo gaming console used for aerobics, strength training, and balance activities. This device includes a balance board that senses weight, movement and balance. Wii-Fit is a TV based self-directed activity not limited by the constraint of a therapist's presence. Virtual trainers talk the user through the activity while tracking progress. Furthermore, visual and auditory feedback improves engagement. Some skilled nursing facilities have started using the Wii-Fit as an adjunct to PT, and note improvement in balance along with social benefits but no systematic studies are done to generalize the findings. The investigators propose an 8 week prospective randomized study with the treatment group receiving the exercise program delivered by Wii-Fit system and the comparison arm receiving a walking exercise program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Falls, Alzheimer's Disease
Keywords
Wii-Fit, Assisted living, Alzheimer's dementia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wii-Fit Intervention
Arm Type
Experimental
Arm Description
Intervention: Subjects in this arm participate in Wii-Fit exercises
Arm Title
Walking Intervention
Arm Type
Active Comparator
Arm Description
Intervention: Subjects in this arm participate in walking
Intervention Type
Other
Intervention Name(s)
Wii-Fit intervention
Other Intervention Name(s)
Exercise intervention
Intervention Description
Half hour daily, 5 days a week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Walking
Other Intervention Name(s)
Exercise intervention
Intervention Description
Half hour daily, five days a week for 8 weeks
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
Balance test
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Activities of Daily Living
Description
Daily functioning test
Time Frame
8 weeks
Title
Instrumental Activities of Daily Living
Description
Higher level of functioning assessment
Time Frame
8 weeks
Title
Timed Up and Go
Description
Functional performance test
Time Frame
8 weeks
Title
Quality of Life-AD
Description
Global quality of life measure
Time Frame
8 weeks
Title
Mini Mental State Exam
Description
Global cognitive screen
Time Frame
8 weeks
Title
Actigraphy
Description
Activity measure
Time Frame
3 days before the intervention and 3 days during the intervention
Title
Trails A and B
Description
Executive function measure
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 60 Alzheimer's Dementia, mild (MMSE ≥ 18) Residing in assisted living facility Presence of legal surrogate Exclusion Criteria: History of myocardial infarction, TIA or stroke in last 6 months Presence of serious mental illness impacting memory Active cancer except skin cancer Medical conditions likely to compromise survival (e.g. severe congestive heart failure) Severe sensory and musculoskeletal impairments Using wheel-chair
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalpana P Padala, MD, MS
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parson's House Assisted Living
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68164
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22745909
Citation
Padala KP, Padala PR, Malloy TR, Geske JA, Dubbert PM, Dennis RA, Garner KK, Bopp MM, Burke WJ, Sullivan DH. Wii-fit for improving gait and balance in an assisted living facility: a pilot study. J Aging Res. 2012;2012:597573. doi: 10.1155/2012/597573. Epub 2012 Jun 13.
Results Reference
result

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Wii-fit for Activity, Balance and Gait in Assisted Living

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