Alzheimer's DementiaNCT01002586
Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia
A study testing Wii-Fit intervention and Walking exercise program in people with Alzheimer's Dementia and Falls, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Dementia, Falls, Gait Impairment
- What is being tested?
- Wii-Fit intervention and Walking exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2009to 6 Jul 2012
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebrasaka Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the detailed description
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.
- Conditions
- Alzheimer's Dementia, Falls, Gait Impairment, Balance Impairment
- Being tested
- Wii-Fit intervention, Walking exercise program
- Keywords
- Alzheimer's dementia, Wii-Fit, Walking, Falls
- 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, five days a week, for 8 weeks
Walking exercise programOther
walking exercise program
| Study group | Role | What they receive |
|---|---|---|
| Wii-Fit arm | Experimental | Half hour daily, five days a week, for 8 weeks Receives: Other: Wii-Fit intervention |
| Walking arm | Active comparator | Half hour daily, five days a week, for 8 weeks Receives: Other: Walking exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks and 16 weeks
Biomechanical assessment of balance
Biomechanical assessment of balance - center of pressure is assessed while standing on a force platform.
Measured: 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.
Measured: 8 weeks and 16 weeks
Secondary outcomes (7)
Activities of daily living (ADL)
The Activities of Daily Living are a series of basic activities necessary for independent living at home or in the community. They are performed on a daily basis. There are 5 basic categories.
- Personal hygiene - bathing/showering, grooming, nail care, and oral care.
- Dressing - being able to make appropriate clothing decisions and physically dress and undress oneself.
- Eating - the ability to feed oneself, though not necessarily the capability to prepare food.
- Maintaining continence - being able to mentally and physically use a restroom. This includes the ability to get on and off the toilet and cleaning oneself.
- Transferring/Mobility- being able to stand from a sitting position, as well as get in and out of bed. The ability to walk independently from one location to another.
These are rated on the basis of the level of independence - a) can be performed independently, b) some assistance needed and c) complete assistance needed.
Measured: 8 weeks and 16 weeks
Instrumental activities of daily living (IADL)
Instrumental Activities of Daily Living are important to being able to live independently, but are not necessarily required on a daily basis. The IADLs include:
- Basic communication skills - such as using a regular phone, mobile phone, email, or the internet.
- Transportation - either by driving oneself, arranging rides, or the ability to use public transportation.
- Meal preparation - meal planning, cooking, clean up, storage, and the ability to safely use kitchen equipment and utensils.
- Shopping - the ability to make appropriate food and clothing purchase decisions.
- Housework - doing laundry, washing dishes, dusting, vacuuming, and maintaining a clean place of residence.
- Managing medications.
- Managing personal finances.
Measured: 8 weeks and 16 weeks
Quality Of Life-AD (QOL-AD)
The QOL-AD is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life from both the patient and the caregiver. The measure consists of 13 items, rated on a four point scale, with 1 being poor and 4 being excellent. Total scores range from 13 to 52. Items include Memory, Mood, Marriage, Physical Health, etc.
Measured: 8 weeks and 16 weeks
Mini mental state exam (MMSE)
The MMSE is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.
Measured: 8 weeks and 16 weeks
Falls Efficacy Scale (FES)
On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, this scale measures how confident the subject is in performing a list of activities without falling.
Measured: 8 weeks and 16 weeks
Activities-specific Balance Confidence Scale (ABC)
Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It's a 16-item questionnaire where patients rate their confidence while doing activities. Scoring from 0-100 (0 is no confidence and 100 is full confidence).
Measured: 8 weeks and 16 weeks
Exit-25
It is a 25-item screening tool that yields a single score reflecting a broad array of executive functions. Each item's possible score ranges from 0 to a maximum of 2 points; total scores range from 0 to 50, with higher scores indicating greater ECF impairment. The items test number/letter sequencing; word and design fluency; sentence-repetition; thematic perception; memory with distraction; interference inhibition; grasp and snout reflexes; social habits; motor perseveration; finger-nose repetition; echopraxia; complex hand sequences; complex commands; counting and serial-order reversal; and automatic, utilization, and imitation behavior.
Measured: 8 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study start1 Nov 2009
- Primary completion6 Jul 2012
- Study completion6 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DementiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT01002586
- Sponsor's protocol ID
- 0361-09-EP
- Status last verified
- Mar 2024
- First submitted
- 23 Oct 2009
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wii-Fit For Improving Activity, Gait And Balance In Alzheimer's Dementia
- ClinicalTrials.gov ID
- NCT01002586
- Acronym / sponsor ID
- 0361-09-EP
- Conditions
- Alzheimer's Dementia, Falls, Gait Impairment, Balance Impairment
- Keywords
- Alzheimer's dementia, Wii-Fit, Walking, Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Nov 2009 (actual)
- Primary completion
- 6 Jul 2012 (actual)
- Study completion
- 6 Jul 2012 (actual)
- First posted
- 27 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wii-Fit arm | Experimental | Other: Wii-Fit interventionHalf hour daily, five days a week, for 8 weeks |
| Walking arm | Active comparator | Other: Walking exercise programHalf hour daily, five days a week, for 8 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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, five days a week, for 8 weeks | Other | Wii-Fit arm |
| Walking exercise programwalking exercise program | Other | Walking arm |
Primary outcome
Berg Balance Test
Time frame: 8 weeks and 16 weeks
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
Biomechanical assessment of balance
Time frame: 8 weeks and 16 weeks
Biomechanical assessment of balance - center of pressure is assessed while standing on a force platform.
Biomechanical assessment of gait
Time frame: 8 weeks and 16 weeks
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.
7 secondary outcomes
Activities of daily living (ADL)
Time frame: 8 weeks and 16 weeks
Instrumental activities of daily living (IADL)
Time frame: 8 weeks and 16 weeks
Quality Of Life-AD (QOL-AD)
Time frame: 8 weeks and 16 weeks
Mini mental state exam (MMSE)
Time frame: 8 weeks and 16 weeks
Falls Efficacy Scale (FES)
Time frame: 8 weeks and 16 weeks
Activities-specific Balance Confidence Scale (ABC)
Time frame: 8 weeks and 16 weeks
Exit-25
Time frame: 8 weeks and 16 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 2 Apr 2024.
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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 exercise program in people with Alzheimer's Dementia and Falls, 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 6 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 2 Apr 2024. 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 Test (time frame: 8 weeks and 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.