Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2007-08-31
2011-06-30
Brief Summary
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Detailed Description
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Aim 1: To determine whether a 12-week, computer-based mental activity program improves cognitive function in non-demented, inactive elders.
We hypothesize that this mental activity program will improve cognitive function-especially visuospatial function-in non-demented, inactive elders.
Aim 2: To determine whether a 12-week exercise program improves cognitive function in non-demented, inactive elders.
We hypothesize that this exercise program will improve cognitive function-especially executive function-in non-demented, inactive elders.
Aim 3: To determine whether the effects of mental activity and exercise are additive or are more or less than the sum of their parts.
We hypothesize that the effects of these mental activity and exercise interventions will be additive.
Aim 4: To determine whether mental activity and/or exercise may slow cognitive decline or lower risk of dementia in non-demented, inactive elders.
We hypothesize that both mental activity and exercise will slow cognitive decline and lower risk of dementia, and that the effects will be greatest when mental activity and exercise are combined.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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Aerobic exercise
Study-specific group exercise classes include 10' warm-up, 30' cardio, 5' cool down, 15' stretching/toning. Target heart rate is 60-75% of maximum. Study participants attend classes 60 min/day, 3 days/week for 12 weeks.
Group 1
Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Group 2
Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
Stretching/toning
Study-specific stretching/toning exercise classes include 10' warm-up, 40' stretching/toning, 10' relaxation. Participants attend classes 60 minutes/day, 3 days/week for 12 weeks.
Group 3
Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Group 4
Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
Computer-based mental activity training
Computer-based visual and auditory stimulation training programs developed by Posit Science corporation. Participants perform assigned mental activity on computers in their homes for 60 minutes/day, 3 days/week for 12 weeks.
Group 1
Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Group 3
Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Educational DVD training
Watching and listening to in-depth, college-level lectures on art, history and science on the computer. Participants perform assigned mental activities 60 minutes/day, 3 days/week for 12 weeks.
Group 2
Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
Group 4
Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
Interventions
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Group 1
Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Group 2
Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
Group 3
Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Group 4
Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Self-report of recent decline in memory or thinking
* Low/no physical activity (\<2 days/week for \<30 minutes/session of moderate intensity activity over past 3 months)
* Low/no computer mental activity (\<2 days/week for \<30 minutes/session over past 3 months)
* Fluent in English
* Willingness to perform study activities
Exclusion Criteria
* Significant central nervous system disorder (Parkinson's disease, multiple sclerosis, ALS \[Lou Gerig's disease\])
* Major, current psychiatric disorder (major depressive disorder, schizophrenia, bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder, psychiatric hospitalization in past 20 years)
* Major central nervous system event (stroke, transient ischemic attack/mini-stroke, seizure, or traumatic brain injury that has left a residual deficit)
* Significant heart disease (severe congestive heart failure, severe aortic stenosis, cardiac arrest, uncontrolled angina)
* Significant lung disease (requiring supplemental oxygen or oral or injected steroids)
* Other condition that would make participation potentially dangerous (cancer requiring treatment in past 3 years, severe arthritis, history of cardiac defibrillation, dialysis)
* Lack of physician approval
* Severe hearing or visual impairment
* History of learning disability
* Starting prescription medication to enhance cognitive function (e.g., memantine, aricept)
* Dependent in any basic activity of daily living (eating, dressing, bathing, toileting, getting out of bed/chair)
* History of alcohol abuse/heavy alcohol use
* History of drug abuse/heavy drug use
* Currently enrolled in another research study
* Fibromyalgia or tremor severe enough to prevent use of a computer mouse
* Planning to travel \> 4 exercise class days during study period
* Behaviors during screening or baseline visit that, in the judgement of research staff, are likely to present significant problems (e.g., uncooperative, anger, inappropriate physical contact)
* Unable to perform neuropsychological evaluations
* Unable to complete consent process
65 Years
ALL
No
Sponsors
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Alzheimer's Association
OTHER
National Institute on Aging (NIA)
NIH
Posit Science Corporation
INDUSTRY
YMCA of San Francisco
UNKNOWN
University of California, San Francisco
OTHER
Responsible Party
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Deborah Barnes
Associate Professor, Psychiatry and Epidemiology & Biostatistics
Principal Investigators
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Deborah E Barnes, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco and San Francisco VA Medical Center
Locations
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San Francisco Veterans Affairs Medical Center
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Countries
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References
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Barnes DE, Santos-Modesitt W, Poelke G, Kramer AF, Castro C, Middleton LE, Yaffe K. The Mental Activity and eXercise (MAX) trial: a randomized controlled trial to enhance cognitive function in older adults. JAMA Intern Med. 2013 May 13;173(9):797-804. doi: 10.1001/jamainternmed.2013.189.
Other Identifiers
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IIRG-06-27306
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BarnesDeborahE-1
Identifier Type: -
Identifier Source: org_study_id
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