Clinical trial NCT01002586: Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia
Official title: Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Dementia
Falls
Gait Impairment
Balance Impairment
Keywords: Alzheimer's dementia
Wii-Fit
Walking
Falls
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 22
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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.

Eligibility 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

Primary outcomes:
measure: Berg Balance Test
timeFrame: 8 weeks and 16 weeks
measure: Biomechanical assessment of balance
timeFrame: 8 weeks and 16 weeks
measure: Biomechanical assessment of gait
timeFrame: 8 weeks and 16 weeks
Secondary outcomes:
measure: Activities of daily living (ADL)
timeFrame: 8 weeks and 16 weeks
measure: Instrumental activities of daily living (IADL)
timeFrame: 8 weeks and 16 weeks
measure: Quality Of Life-AD (QOL-AD)
timeFrame: 8 weeks and 16 weeks
measure: Mini mental state exam (MMSE)
timeFrame: 8 weeks and 16 weeks
measure: Falls Efficacy Scale (FES)
timeFrame: 8 weeks and 16 weeks
measure: Activities-specific Balance Confidence Scale (ABC)
timeFrame: 8 weeks and 16 weeks
measure: Exit-25
timeFrame: 8 weeks and 16 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebrasaka Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Kalpana P Padala, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: