Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT01002586

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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. 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 or Disease	Intervention/Treatment	Phase
Alzheimer's Dementia Falls Gait Impairment Balance Impairment	Other: Wii-Fit intervention Other: Walking exercise program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia

Actual Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Exercise intervention
Active Comparator: Walking arm Half hour daily, five days a week, for 8 weeks	Other: Walking exercise program walking exercise program

Arm

Intervention/Treatment

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 Names:

Exercise intervention

Active Comparator: Walking arm

Half hour daily, five days a week, for 8 weeks

Other: Walking exercise program

walking exercise program

Outcome Measures

Primary Outcome Measures

Berg Balance Test [8 weeks and 16 weeks]
Biomechanical assessment of balance, gait and dual tasking [8 weeks and 16 weeks]

Secondary Outcome Measures

Activities of daily living (ADL) [8 weeks and 16 weeks]
Instrumental activities of daily living (IADL) [8 weeks and 16 weeks]
Quality Of Life-AD (QOL-AD) [8 weeks and 16 weeks]
Mini mental state exam (MMSE) [8 weeks and 16 weeks]
Falls Efficacy Scale (FES) [8 weeks and 16 weeks]
Activities-specific Balance Confidence Scale (ABC) [8 weeks and 16 weeks]
Exit-25 [8 weeks and 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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