Clinical trial NCT01000038: Wii-fit for Activity, Balance and Gait in Assisted Living
Official title: Wii-fit for Activity, Balance and Gait in Assisted Living
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls
Alzheimer's Disease
Keywords: Wii-Fit
Assisted living
Alzheimer's dementia
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 22
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Falls in Alzheimer's Disease (AD) are common and lead to fractures, acute hospitalizations and increased rate of institutionalization. Poor balance and gait abnormalities, commonly associated with AD, are risk factors. Improving balance and gait abnormalities is critical in preventing these falls. Walking is the most commonly recommended home-based exercise program for elderly by primary care providers. However, it is difficult to engage patients with AD in long term exercise programs. Barriers include lack of motivation, poor engagement, and external factors such as the cost of physical therapy (PT).

The use of readily available technology might bridge this gap by providing high level of engagement via use of multimedia at an affordable price. Wii-Fit is a Nintendo gaming console used for aerobics, strength training, and balance activities. It is a TV based self-directed activity where virtual trainers talk the user through the activity while tracking progress. Some skilled nursing facilities have started using the Wii-Fit as an adjunct to PT and note improvement in balance along with social benefits, but no systematic studies are done to generalize the findings. This study will compare changes in balance and daily living activities between a group receiving Wii-Fit training and another receiving a walking exercise program.

Detailed description: Purpose of the study: Falls in Alzheimer's Disease (AD) are common and lead to fractures, acute hospitalizations and increased rate of institutionalization. Poor balance and gait abnormalities, commonly associated with AD, are risk factors for falls. Improving balance and gait abnormalities is critical to prevent falls in AD.

Exercise interventions improve gait and balance in elderly. Walking is the most commonly recommended home-based exercise program for elderly by primary care providers. However, it is difficult to engage patients with AD in long term exercise programs. Barriers to exercise programs include lack of motivation, poor engagement, and external factors such as the cost of physical therapy (PT). Use of readily available technology might bridge this gap by providing high level of engagement via use of multimedia at an affordable price.

Wii-Fit is a Nintendo gaming console used for aerobics, strength training, and balance activities. This device includes a balance board that senses weight, movement and balance. Wii-Fit is a TV based self-directed activity not limited by the constraint of a therapist's presence. Virtual trainers talk the user through the activity while tracking progress. Furthermore, visual and auditory feedback improves engagement. Some skilled nursing facilities have started using the Wii-Fit as an adjunct to PT, and note improvement in balance along with social benefits but no systematic studies are done to generalize the findings.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60
* Alzheimer's Dementia, mild (MMSE ≥ 18)
* Residing in assisted living facility
* Presence of legal surrogate

Exclusion Criteria:

* History of myocardial infarction, TIA or stroke in last 6 months
* Presence of serious mental illness impacting memory
* Active cancer except skin cancer
* Medical conditions likely to compromise survival (e.g. severe congestive heart failure)
* Severe sensory and musculoskeletal impairments
* Using wheel-chair

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Activities of Daily Living
timeFrame: 8 weeks
measure: Instrumental Activities of Daily Living
timeFrame: 8 weeks
measure: Timed Up and Go
timeFrame: 8 weeks
measure: Quality of Life-AD
timeFrame: 8 weeks
measure: Mini Mental State Exam
timeFrame: 8 weeks
measure: Actigraphy
timeFrame: 3 days before the intervention and 3 days during the intervention
measure: Trails A and B
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Parson's House Assisted Living
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Kalpana P Padala, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Padala KP, Padala PR, Malloy TR, Geske JA, Dubbert PM, Dennis RA, Garner KK, Bopp MM, Burke WJ, Sullivan DH. Wii-fit for improving gait and balance in an assisted living facility: a pilot study. J Aging Res. 2012;2012:597573. doi: 10.1155/2012/597573. Epub 2012 Jun 13.