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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Berg Balance Scale [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Activities of Daily Living [ Time Frame: 8 weeks ]
  • Instrumental Activities of Daily Living [ Time Frame: 8 weeks ]
  • Timed Up and Go [ Time Frame: 8 weeks ]
  • Quality of Life-AD [ Time Frame: 8 weeks ]
  • Mini Mental State Exam [ Time Frame: 8 weeks ]
  • Actigraphy [ Time Frame: 3 days before the intervention and 3 days during the intervention ]
  • Trails A and B [ Time Frame: 8 weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 28, 2017