Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 |
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| Contact: Kalpana P Padala, MD, MS | 402-559-8069 | kpadala@unmc.edu |
| 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 | |
| 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 Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013