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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01002586
First received: October 23, 2009
Last updated: June 1, 2010
Last verified: June 2010
  Purpose

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 Intervention
Alzheimer's Dementia
Falls
Gait Impairment
Balance Impairment
Other: Wii-Fit intervention
Other: Walking exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Berg Balance Test [ Time Frame: 8 weeks and 16 weeks ] [ Designated as safety issue: No ]
  • Biomechanical assessment of balance, gait and dual tasking [ Time Frame: 8 weeks and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Activities of daily living (ADL) [ Time Frame: 8 weeks and 16 weeks ] [ Designated as safety issue: No ]
  • Instrumental activities of daily living (IADL) [ Time Frame: 8 weeks and 16 weeks ] [ Designated as safety issue: No ]
  • Quality Of Life-AD (QOL-AD) [ Time Frame: 8 weeks and 16 weeks ] [ Designated as safety issue: No ]
  • Mini mental state exam (MMSE) [ Time Frame: 8 weeks and 16 weeks ] [ Designated as safety issue: No ]
  • Falls Efficacy Scale (FES) [ Time Frame: 8 weeks and 16 weeks ] [ Designated as safety issue: No ]
  • Activities-specific Balance Confidence Scale (ABC) [ Time Frame: 8 weeks and 16 weeks ] [ Designated as safety issue: No ]
  • Exit-25 [ Time Frame: 8 weeks and 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
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: NCT01002586

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

Locations
United States, Nebraska
University of Nebrasaka Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Kalpana P Padala, MD, MS    402-559-8069    kpadala@unmc.edu   
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 Nebrasaka Medical Center
ClinicalTrials.gov Identifier: NCT01002586     History of Changes
Other Study ID Numbers: 361-09-EP
Study First Received: October 23, 2009
Last Updated: June 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Alzheimer's dementia
Wii-Fit
Walking
Falls

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

ClinicalTrials.gov processed this record on October 29, 2014