- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01002586
Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia
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. Exercise interventions improve gait and balance in the elderly. In participants 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. 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 in a community dwelling setting. Subjects in each arm will participate for 30 minutes daily five days a week.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68198
- University Of Nebrasaka Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wii-Fit arm
Half hour daily, five days a week, for 8 weeks
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Half hour daily, five days a week, for 8 weeks
Other Names:
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Active Comparator: Walking arm
Half hour daily, five days a week, for 8 weeks
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walking exercise program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Test
Time Frame: 8 weeks and 16 weeks
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The Berg Balance Scale involves 14 mobility tasks, divided into 3 domains: sitting balance, standing balance, and dynamic balance.
In the sitting balance, the task is the evaluation of sitting unsupported.
Standing balance consist of standing unsupported, standing with eyes closed, standing with feet together, standing on one foot, turning to look behind, grabbing an object from the floor, reaching forward with outstretched arms, and placing one foot in front of the other.
In the last domain, the dynamic balance is evaluated with the individual going from sitting to standing, standing to sitting, transferring, turning 360 degrees, placing one foot on a step.
Each task is graded on a 5-point ordinal scale that ranges from 0 to 4 for a maximum score of 56.
In general, a score of 0 is given when the individual is unable to perform the task, and a
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8 weeks and 16 weeks
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Biomechanical assessment of balance
Time Frame: 8 weeks and 16 weeks
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Biomechanical assessment of balance - center of pressure is assessed while standing on a force platform.
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8 weeks and 16 weeks
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Biomechanical assessment of gait
Time Frame: 8 weeks and 16 weeks
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Biomechanical assessment of gait - reflective markers attached to anatomical landmarks are tracked with motion capture cameras that provide body segment position data as subjects walk on a treadmill.
The position data is then used to calculate joint movements, velocities, etc.
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8 weeks and 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activities of daily living (ADL)
Time Frame: 8 weeks and 16 weeks
|
The Activities of Daily Living are a series of basic activities necessary for independent living at home or in the community. They are performed on a daily basis. There are 5 basic categories.
These are rated on the basis of the level of independence - a) can be performed independently, b) some assistance needed and c) complete assistance needed. |
8 weeks and 16 weeks
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Instrumental activities of daily living (IADL)
Time Frame: 8 weeks and 16 weeks
|
Instrumental Activities of Daily Living are important to being able to live independently, but are not necessarily required on a daily basis. The IADLs include:
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8 weeks and 16 weeks
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Quality Of Life-AD (QOL-AD)
Time Frame: 8 weeks and 16 weeks
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The QOL-AD is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life from both the patient and the caregiver.
The measure consists of 13 items, rated on a four point scale, with 1 being poor and 4 being excellent.
Total scores range from 13 to 52.
Items include Memory, Mood, Marriage, Physical Health, etc.
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8 weeks and 16 weeks
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Mini mental state exam (MMSE)
Time Frame: 8 weeks and 16 weeks
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The MMSE is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language.
The maximum score is 30.
A score of 23 or lower is indicative of cognitive impairment.
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8 weeks and 16 weeks
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Falls Efficacy Scale (FES)
Time Frame: 8 weeks and 16 weeks
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On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, this scale measures how confident the subject is in performing a list of activities without falling.
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8 weeks and 16 weeks
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Activities-specific Balance Confidence Scale (ABC)
Time Frame: 8 weeks and 16 weeks
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Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness.
It's a 16-item questionnaire where patients rate their confidence while doing activities.
Scoring from 0-100 (0 is no confidence and 100 is full confidence).
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8 weeks and 16 weeks
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Exit-25
Time Frame: 8 weeks and 16 weeks
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It is a 25-item screening tool that yields a single score reflecting a broad array of executive functions.
Each item's possible score ranges from 0 to a maximum of 2 points; total scores range from 0 to 50, with higher scores indicating greater ECF impairment.
The items test number/letter sequencing; word and design fluency; sentence-repetition; thematic perception; memory with distraction; interference inhibition; grasp and snout reflexes; social habits; motor perseveration; finger-nose repetition; echopraxia; complex hand sequences; complex commands; counting and serial-order reversal; and automatic, utilization, and imitation behavior.
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8 weeks and 16 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kalpana P Padala, MD, MS, University of Nebraska
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0361-09-EP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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