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Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia

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ClinicalTrials.gov Identifier: NCT01002586
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Mukul Mukherjee, University of Nebraska

Study Description
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Brief Summary:

Alzheimer's Dementia (AD) contributes to poor balance, impaired gait and functional status, thereby, increasing the risk of falls. AD is an independent risk factor for hip fractures. Those with balance problems and gait impairments are at higher risk for long term placement and death related to falls. Gait impairments in those with dementia include shortened step length, increased double support time, step to step variability, and decreased gait speed. These gait impairments worsen with dual tasking probably due to common brain areas involved in gait and other cognitive tasks.

Exercise interventions improve gait and balance in the elderly. In subjects with existing AD, physical activity has shown to prevent further cognitive decline and improve quality of life and prevent falls. However, it is difficult to engage patients with AD in long term exercise programs. The expense of physical therapy limits its easy accessibility. Use of everyday technology might bridge this gap by providing high level of engagement via the use of multimedia while providing a cost effective alternative. Wii Fit is one such multimedia platform.

Wii fit is a Nintendo gaming console used for aerobics, strength training and balance activities. This device includes a balance board that senses weight and shifts in movement and balance. Virtual trainers talk the user through the activity while tracking the user's progress.

Although some skilled nursing facilities have started using Wii game system adjunct to routine physical therapy, there have not been any studies. Anecdotal reports note improvement in balance and social benefits using the Wii Fit program. Physical therapists report the ability to customize Wii for each patient. Wii Fit can be successfully used in a cognitively impaired population. A unique feature of this approach is the enjoyment and enthusiasm that many patients derive which is reflected in high levels of engagement.

The invesitgators 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 in a community dwelling setting. Subjects in each arm will participate for 30 minutes daily five days a week.


Condition or disease Intervention/treatment Phase
Alzheimer's Dementia Falls Gait Impairment Balance Impairment Other: Wii-Fit intervention Other: Walking exercise program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia
Actual Study Start Date : November 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Wii-Fit arm
Half hour daily, five days a week, for 8 weeks
 Other: Wii-Fit intervention
Half hour daily, five days a week, for 8 weeks
Other Name: Exercise intervention
Active Comparator: Walking arm
Half hour daily, five days a week, for 8 weeks
 Other: Walking exercise program
walking exercise program


Outcome Measures
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Primary Outcome Measures :
  1. Berg Balance Test [ Time Frame: 8 weeks and 16 weeks ]
  2. Biomechanical assessment of balance, gait and dual tasking [ Time Frame: 8 weeks and 16 weeks ]

Secondary Outcome Measures :
  1. Activities of daily living (ADL) [ Time Frame: 8 weeks and 16 weeks ]
  2. Instrumental activities of daily living (IADL) [ Time Frame: 8 weeks and 16 weeks ]
  3. Quality Of Life-AD (QOL-AD) [ Time Frame: 8 weeks and 16 weeks ]
  4. Mini mental state exam (MMSE) [ Time Frame: 8 weeks and 16 weeks ]
  5. Falls Efficacy Scale (FES) [ Time Frame: 8 weeks and 16 weeks ]
  6. Activities-specific Balance Confidence Scale (ABC) [ Time Frame: 8 weeks and 16 weeks ]
  7. Exit-25 [ Time Frame: 8 weeks and 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects age ≥ 60
  • Diagnosis of mild Dementia of Alzheimer's type (MMSE ≥ 18)
  • Community dwelling elders, living at home
  • History of fall at least once during the year before the study (without serious injury) or a fear of a future fall
  • Presence of caregiver(s)
  • Presence of television at home

Exclusion Criteria:

  • History of myocardial infarction or TIA or stroke in last 6 months
  • Presence of serious psychiatric problems that have impact on memory
  • Active cancer or new cancer diagnosis in the last year other than skin cancer
  • Medical conditions likely to compromise survival, or ability to participate in the exercise program such as severe congestive heart failure, significant musculoskeletal impairments, recent fracture, joint replacements, or severe chronic pain
  • Severe visual or auditory impairment or peripheral neuropathy
  • Subjects using wheel chair or assistive device for mobility
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002586


Locations
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United States, Nebraska
University of Nebrasaka Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Kalpana P Padala, MD, MS University of Nebraska
More Information
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Responsible Party: Mukul Mukherjee, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01002586    
Other Study ID Numbers: 361-09-EP
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Keywords provided by Mukul Mukherjee, University of Nebraska:
Alzheimer's dementia
Wii-Fit
Walking
Falls
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases