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

September 13, 2023 updated by: University of Nebraska

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68164
        • Parson's House Assisted Living

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wii-Fit Intervention
Intervention: Subjects in this arm participate in Wii-Fit exercises
Other: Wii-Fit intervention
Half hour daily, 5 days a week for 8 weeks
Other Names:
  • Exercise intervention
Other: Walking
Half hour daily, five days a week for 8 weeks
Other Names:
  • Exercise intervention
Active Comparator: Walking Intervention
Intervention: Subjects in this arm participate in walking
Other: Walking
Half hour daily, five days a week for 8 weeks
Other Names:
  • Exercise intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 8 weeks
Balance test
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities of Daily Living
Time Frame: 8 weeks
Daily functioning test
8 weeks
Instrumental Activities of Daily Living
Time Frame: 8 weeks
Higher level of functioning assessment
8 weeks
Timed Up and Go
Time Frame: 8 weeks
Functional performance test
8 weeks
Quality of Life-AD
Time Frame: 8 weeks
Global quality of life measure
8 weeks
Mini Mental State Exam
Time Frame: 8 weeks
Global cognitive screen
8 weeks
Actigraphy
Time Frame: 3 days before the intervention and 3 days during the intervention
Activity measure
3 days before the intervention and 3 days during the intervention
Trails A and B
Time Frame: 8 weeks
Executive function measure
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Kalpana P Padala, MD, MS, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2009

Primary Completion (Actual)

July 7, 2011

Study Completion (Actual)

July 7, 2011

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (Estimated)

October 22, 2009

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0085-09-FB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on Wii-Fit intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe