FallsNCT01000038
Wii-fit for Activity, Balance and Gait in Assisted Living
A study testing Wii-Fit intervention and Walking in people with Falls and Alzheimer's Disease, run by University of Nebraska at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Falls, Alzheimer's Disease
- What is being tested?
- Wii-Fit intervention and Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2009to 7 Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60
- Alzheimer's Dementia, mild (MMSE ≥ 18)
- Residing in assisted living facility
- Presence of legal surrogate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Parson's House Assisted Living
Omaha, Nebraska, 68164
About this 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. 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.
Read the 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.
- Conditions
- Falls, Alzheimer's Disease
- Being tested
- Wii-Fit intervention, Walking
- Keywords
- Wii-Fit, Assisted living, Alzheimer's dementia
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii-Fit interventionOther
Also called Exercise intervention
Half hour daily, 5 days a week for 8 weeks
WalkingOther
Also called Exercise intervention
Half hour daily, five days a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Wii-Fit Intervention | Experimental | Intervention: Subjects in this arm participate in Wii-Fit exercises Receives: Other: Wii-Fit intervention; Other: Walking |
| Walking Intervention | Active comparator | Intervention: Subjects in this arm participate in walking Receives: Other: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Balance test
Measured: 8 weeks
Secondary outcomes (7)
Activities of Daily Living
Daily functioning test
Measured: 8 weeks
Instrumental Activities of Daily Living
Higher level of functioning assessment
Measured: 8 weeks
Timed Up and Go
Functional performance test
Measured: 8 weeks
Quality of Life-AD
Global quality of life measure
Measured: 8 weeks
Mini Mental State Exam
Global cognitive screen
Measured: 8 weeks
Actigraphy
Activity measure
Measured: 3 days before the intervention and 3 days during the intervention
Trails A and B
Executive function measure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study start30 Mar 2009
- Primary completion7 Jul 2011
- Study completion7 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kalpana P Padala, MD, MS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000038
- Sponsor's protocol ID
- 0085-09-FB
- Status last verified
- Sep 2023
- First submitted
- 20 Oct 2009
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22745909
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wii-fit for Activity, Balance and Gait in Assisted Living
- ClinicalTrials.gov ID
- NCT01000038
- Acronym / sponsor ID
- 0085-09-FB
- Conditions
- Falls, Alzheimer's Disease
- Keywords
- Wii-Fit, Assisted living, Alzheimer's dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 30 Mar 2009 (actual)
- Primary completion
- 7 Jul 2011 (actual)
- Study completion
- 7 Jul 2011 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wii-Fit Intervention | Experimental | Other: Wii-Fit intervention, Other: WalkingIntervention: Subjects in this arm participate in Wii-Fit exercises |
| Walking Intervention | Active comparator | Other: WalkingIntervention: Subjects in this arm participate in walking |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 60
- Alzheimer's Dementia, mild (MMSE ≥ 18)
- Residing in assisted living facility
- Presence of legal surrogate
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wii-Fit interventionAlso: Exercise interventionHalf hour daily, 5 days a week for 8 weeks | Other | Wii-Fit Intervention |
| WalkingAlso: Exercise interventionHalf hour daily, five days a week for 8 weeks | Other | Walking Intervention, Wii-Fit Intervention |
Primary outcome
Berg Balance Scale
Time frame: 8 weeks
Balance test
7 secondary outcomes
Activities of Daily Living
Time frame: 8 weeks
Instrumental Activities of Daily Living
Time frame: 8 weeks
Timed Up and Go
Time frame: 8 weeks
Quality of Life-AD
Time frame: 8 weeks
Mini Mental State Exam
Time frame: 8 weeks
Actigraphy
Time frame: 3 days before the intervention and 3 days during the intervention
Trails A and B
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Results publication: PubMed 22745909Padala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalpana P Padala, MD, MS principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii-Fit intervention and Walking in people with Falls and Alzheimer's Disease, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.