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

NCT01002586 | Completed

• 1 other identifier: 0361-09-EP
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Dementia; Falls; Gait Impairment; Balance Impairment

Keywords

Alzheimer's dementia; Wii-Fit; Walking; Falls

Outcome Measures

Primary Outcomes (3)

• Berg Balance Test

  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

  8 weeks and 16 weeks

• Biomechanical assessment of balance

  Biomechanical assessment of balance - center of pressure is assessed while standing on a force platform.

  8 weeks and 16 weeks

• Biomechanical assessment of gait

  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.

  8 weeks and 16 weeks

Secondary Outcomes (7)

• 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

Study Arms (2)

Wii-Fit arm

EXPERIMENTAL

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

Other: Wii-Fit intervention

Walking arm

ACTIVE COMPARATOR

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

Other: Walking exercise program

Interventions

Wii-Fit intervention OTHER

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

Also known as: Exercise intervention

Wii-Fit arm

Walking exercise program OTHER

walking exercise program

Walking arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebrasaka Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kalpana P Padala, MD, MS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 27, 2009
• Study Start: November 1, 2009
• Primary Completion: July 6, 2012
• Study Completion: July 6, 2012
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

US (1)