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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01000038
Other study ID # 0085-09-FB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2009
Est. completion date July 7, 2011

Study information

Verified date September 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date July 7, 2011
Est. primary completion date July 7, 2011
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Wii-Fit intervention
Half hour daily, 5 days a week for 8 weeks
Walking
Half hour daily, five days a week for 8 weeks

Locations

Country Name City State
United States Parson's House Assisted Living Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Berg Balance Scale Balance test 8 weeks
Secondary Activities of Daily Living Daily functioning test 8 weeks
Secondary Instrumental Activities of Daily Living Higher level of functioning assessment 8 weeks
Secondary Timed Up and Go Functional performance test 8 weeks
Secondary Quality of Life-AD Global quality of life measure 8 weeks
Secondary Mini Mental State Exam Global cognitive screen 8 weeks
Secondary Actigraphy Activity measure 3 days before the intervention and 3 days during the intervention
Secondary Trails A and B Executive function measure 8 weeks
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