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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01000038
First received: October 20, 2009
Last updated: October 23, 2009
Last verified: October 2009
History of Changes
  Purpose

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 Intervention
Falls
Alzheimer's Disease
 Other: Wii-Fit intervention
Other: Walking

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Wii-fit for Activity, Balance and Gait in Assisted Living

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Berg Balance Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Activities of Daily Living [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Instrumental Activities of Daily Living [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Timed Up and Go [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Quality of Life-AD [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Mini Mental State Exam [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Actigraphy [ Time Frame: 3 days before the intervention and 3 days during the intervention ] [ Designated as safety issue: No ]
  • Trails A and B [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: March 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wii-Fit arm Other: Wii-Fit intervention
Half hour daily, 5 days a week for 8 weeks
Other Name: Exercise intervention
Other: Walking
Half hour daily, five days a week for 8 weeks
Other Name: Exercise intervention
Active Comparator: Walking arm Other: Walking
Half hour daily, five days a week for 8 weeks
Other Name: Exercise intervention

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000038

Contacts
Contact: Kalpana P Padala, MD,MS 402-559-8069 kpadala@unmc.edu

Locations
United States, Nebraska
Parson's House Assisted Living Recruiting
Omaha, Nebraska, United States, 68164
Principal Investigator: Kalpana P Padala, MD, MS            
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Kalpana P Padala, MD, MS University of Nebraska
  More Information

No publications provided

Responsible Party: Kalpana P. Padala, MD, MS, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT01000038     History of Changes
Other Study ID Numbers: 085-09-FB
Study First Received: October 20, 2009
Last Updated: October 23, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Wii-Fit
Assisted living
Alzheimer's dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013