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

Sponsor
University of Nebraska (Other)
Overall Status
Completed
CT.gov ID
NCT01000038
Collaborator
(none)
22
1
2
28
0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Wii-Fit intervention
  • Other: Walking
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Wii-fit for Activity, Balance and Gait in Assisted Living
Actual Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Berg Balance Scale [8 weeks]

      Balance test

    Secondary Outcome Measures

    1. Activities of Daily Living [8 weeks]

      Daily functioning test

    2. Instrumental Activities of Daily Living [8 weeks]

      Higher level of functioning assessment

    3. Timed Up and Go [8 weeks]

      Functional performance test

    4. Quality of Life-AD [8 weeks]

      Global quality of life measure

    5. Mini Mental State Exam [8 weeks]

      Global cognitive screen

    6. Actigraphy [3 days before the intervention and 3 days during the intervention]

      Activity measure

    7. Trails A and B [8 weeks]

      Executive function measure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Parson's House Assisted Living Omaha Nebraska United States 68164

    Sponsors and Collaborators

    • University of Nebraska

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kalpana Padala, MD, MS, Principal Investigator, University of Nebraska
    ClinicalTrials.gov Identifier:
    NCT01000038
    Other Study ID Numbers:
    • 085-09-FB
    First Posted:
    Oct 22, 2009
    Last Update Posted:
    Aug 27, 2018
    Last Verified:
    Aug 1, 2018
    Keywords provided by Kalpana Padala, MD, MS, Principal Investigator, University of Nebraska
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 27, 2018