NCT01000038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2011

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

October 20, 2009

Last Update Submit

September 13, 2023

Conditions

FallsAlzheimer's Disease

Keywords

Wii-FitAssisted livingAlzheimer's dementia

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

    Balance test

    8 weeks

Secondary Outcomes (7)

  • Activities of Daily Living

    8 weeks

  • Instrumental Activities of Daily Living

    8 weeks

  • Timed Up and Go

    8 weeks

  • Quality of Life-AD

    8 weeks

  • Mini Mental State Exam

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Wii-Fit Intervention

EXPERIMENTAL

Intervention: Subjects in this arm participate in Wii-Fit exercises

Other: Wii-Fit interventionOther: Walking

Walking Intervention

ACTIVE COMPARATOR

Intervention: Subjects in this arm participate in walking

Other: Walking

Interventions

Wii-Fit interventionOTHER

Half hour daily, 5 days a week for 8 weeks

Also known as: Exercise intervention
Wii-Fit Intervention
WalkingOTHER

Half hour daily, five days a week for 8 weeks

Also known as: Exercise intervention
Walking InterventionWii-Fit Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parson's House Assisted Living

Omaha, Nebraska, 68164, United States

Location

Related 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. Epub 2012 Jun 13.

    PMID: 22745909RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Walking

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Kalpana P Padala, MD, MS

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 22, 2009

Study Start

March 30, 2009

Primary Completion

July 7, 2011

Study Completion

July 7, 2011

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

US(1)