Mild Cognitive ImpairmentNCT00446394
Exercise and Activities for Independent Living With Mild Cognitive Impairment (MCI)
A study testing Resources and Activities for Life Long Independence (RALLI) and Social Walking program (SW) in people with Mild Cognitive Impairment and Dementia, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this project is to evaluate an exercise and health promotion program for older adults with mild memory loss. The study will investigate the efficacy of a memory-enhanced exercise and health promotion program to determine whether it is more effective than a social walking program in delaying further… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Dementia
- What is being tested?
- Resources and Activities for Life Long Independence (RALLI) and Social Walking program (SW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Oct 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Mild Cognitive Impairment defined as
- - Memory complaint
- - Objective memory impairment for age and education
- - Largely intact general cognitive function
- - Essentially preserved activities of daily living
- - Not already diagnosed with dementia
- Insufficient physical activity defined as less than 150 minutes per week of moderate intensity physical activity
- Not currently in an exercise program similar to the study program
Who cannot join
- Not ambulatory
- Expected to move from the study geographic area during the study period
- Have a known terminal illness
- Actively suicidal, hallucinating, or delusional
- Hospitalized for a psychiatric disorder in the 12 months before baseline
- Uncontrolled chronic conditions, e.g. uncontrolled hypertension, unstable angina, uncontrolled blood glucose
- Blind or deaf
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest Research Group on Aging, Department of Psychosocial and Community Health, University of Washington School of Nursing
Seattle, Washington, 98105
About this study
Official title: Exercise & Health Promotion for MCI: A Controlled Trial
The purpose of this project is to evaluate an exercise and health promotion program for older adults with mild memory loss. The study will investigate the efficacy of a memory-enhanced exercise and health promotion program to determine whether it is more effective than a social walking program in delaying further memory decline, improving mood and physical function, and enhancing quality of life.
Read the detailed description
This project is a randomized controlled trial to evaluate the efficacy of a group exercise and health promotion program designed specifically for older adults with Mild Cognitive Impairment (MCI). This study builds upon previous studies designed for cognitively intact older adults, with a supplemental study using a modified intervention for MCI participants, and for individuals with Alzheimer's disease.
Taken together, these prior investigations support the efficacy of behaviorally based exercise interventions in improving cognitive, physical, and affective status in cognitively intact and demented older adults. Results from a feasibility study suggest that these positive outcomes can also be obtained in older adults with MCI.
The current study will investigate the efficacy of the modified exercise program called RALLI (Resources and Activities for Life Long Independence) to determine whether it is more effective than the control condition, a social walking program (SW), in delaying cognitive decline, improving self-rated health and health behaviors, improving affect and physical function, and enhancing quality of life. The long-term efficacy of RALLI to delay conversion of MCI to dementia, reduce physical disability, maintain independent living, and improve physiological health indicators will also be investigated.
One hundred seventy participants over the age of 70 who meet American Academy of Neurology criteria for MCI will be recruited from independent living retirement residences. Participants will be randomly assigned to one of the two conditions (RALLI and SW) and assessed at baseline, post treatment (3 months), and follow up visits every 6 months for a total of 3 years (months 6, 12, 18, 24, 30, and 36). The hypothesis is that RALLI participants will experience better post-treatment outcomes than SW participants, and that gains will be maintained over 36 months.
- Conditions
- Mild Cognitive Impairment, Dementia
- Being tested
- Resources and Activities for Life Long Independence (RALLI), Social Walking program (SW)
- Keywords
- cognition disorder, functional ability, psychomotor function, psychopathology, quality of life
- Medical subject headings
- Cognitive Dysfunction, Dementia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resources and Activities for Life Long Independence (RALLI)Behavioural
Strengthening exercises, encouragement to walk daily, pedometer reading, health promotion information for 1.5 hours weekly for 9 weeks
Social Walking program (SW)Behavioural
Group support for walking, pedometer reading, 1 hour weekly for 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Resources and Activities for Life Long Independence (RALLI) |
| 2 | Active comparator | Not described Receives: Behavioral: Social Walking program (SW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive status
Measured: baseline, 3, 6, 12, 18, 24, 30, and 36 months
Secondary outcomes (1)
Changes in health, affective, and functional status
Measured: baseline, 3, 6, 12, 18, 24, 30, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Teri, University of Washington
- Investigators
- Linda Teri, PhD, Principal investigator, University of Washington School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446394
- Sponsor's protocol ID
- 30692-J
- Other IDs
- 2R01AG014777, IA0100, 06-3067-C
- Status last verified
- Oct 2012
- First submitted
- 8 Mar 2007
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise & Health Promotion for MCI: A Controlled Trial
- ClinicalTrials.gov ID
- NCT00446394
- Acronym / sponsor ID
- 30692-J
- Conditions
- Mild Cognitive Impairment, Dementia
- Keywords
- cognition disorder, functional ability, psychomotor function, psychopathology, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Mar 2007 (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.
The purpose of this project is to evaluate an exercise and health promotion program for older adults with mild memory loss. The study will investigate the efficacy of a memory-enhanced exercise and health promotion program to determine whether it is more effective than a social walking program in delaying further memory decline, improving mood and physical function, and enhancing quality of life.
Detailed description
This project is a randomized controlled trial to evaluate the efficacy of a group exercise and health promotion program designed specifically for older adults with Mild Cognitive Impairment (MCI). This study builds upon previous studies designed for cognitively intact older adults, with a supplemental study using a modified intervention for MCI participants, and for individuals with Alzheimer's disease.
Taken together, these prior investigations support the efficacy of behaviorally based exercise interventions in improving cognitive, physical, and affective status in cognitively intact and demented older adults. Results from a feasibility study suggest that these positive outcomes can also be obtained in older adults with MCI.
The current study will investigate the efficacy of the modified exercise program called RALLI (Resources and Activities for Life Long Independence) to determine whether it is more effective than the control condition, a social walking program (SW), in delaying cognitive decline, improving self-rated health and health behaviors, improving affect and physical function, and enhancing quality of life. The long-term efficacy of RALLI to delay conversion of MCI to dementia, reduce physical disability, maintain independent living, and improve physiological health indicators will also be investigated.
One hundred seventy participants over the age of 70 who meet American Academy of Neurology criteria for MCI will be recruited from independent living retirement residences. Participants will be randomly assigned to one of the two conditions (RALLI and SW) and assessed at baseline, post treatment (3 months), and follow up visits every 6 months for a total of 3 years (months 6, 12, 18, 24, 30, and 36). The hypothesis is that RALLI participants will experience better post-treatment outcomes than SW participants, and that gains will be maintained over 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Resources and Activities for Life Long Independence (RALLI) |
| 2 | Active comparator | Behavioral: Social Walking program (SW) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Mild Cognitive Impairment defined as
- - Memory complaint
- - Objective memory impairment for age and education
- - Largely intact general cognitive function
- - Essentially preserved activities of daily living
Key exclusion criteria (7 listed)
- Not ambulatory
- Expected to move from the study geographic area during the study period
- Have a known terminal illness
- Actively suicidal, hallucinating, or delusional
- Hospitalized for a psychiatric disorder in the 12 months before baseline
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 |
|---|---|---|
| Resources and Activities for Life Long Independence (RALLI)Strengthening exercises, encouragement to walk daily, pedometer reading, health promotion information for 1.5 hours weekly for 9 weeks | Behavioural | 1 |
| Social Walking program (SW)Group support for walking, pedometer reading, 1 hour weekly for 9 weeks | Behavioural | 2 |
Primary outcome
Changes in cognitive status
Time frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months
1 secondary outcome
Changes in health, affective, and functional status
Time frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months
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 19 Oct 2012.
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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.
Linda Teri, PhD principal investigator
University of Washington School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resources and Activities for Life Long Independence (RALLI) and Social Walking program (SW) in people with Mild Cognitive Impairment and Dementia, run by University of Washington 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 8 inclusion and 7 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 19 Oct 2012. 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?
Changes in cognitive status (time frame: baseline, 3, 6, 12, 18, 24, 30, and 36 months). 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 19 Oct 2012.