The Mental Activity and eXercise Trial for Seniors (MAX)
This study has been completed.
Sponsor:
University of California, San Francisco
Collaborators:
Alzheimer's Association
Posit Science Corporation
YMCA of San Francisco
Information provided by (Responsible Party):
Deborah Barnes, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00522899
First received: August 28, 2007
Last updated: April 6, 2012
Last verified: April 2012
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Purpose
The primary objective of this study is to conduct a randomized, controlled trial to determine whether engaging in mental activity or exercise, either alone or in combination, improves cognitive function in non-demented, inactive older adults who self-report a recent decline in memory or thinking. In addition, we, the researchers at the University of California, San Francisco, plan to seek funding to follow subjects over time to determine whether these interventions are associated with changes in rate of cognitive decline or risk of dementia after the intervention period has ended.
| Condition | Intervention |
|---|---|
|
Cognitive Impairment |
Behavioral: Group 1 Behavioral: Group 2 Behavioral: Group 3 Behavioral: Group 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Effects of Mental Activity and Exercise on Cognitive Function in Older Adults Who Self-Report a Recent Decline in Memory or Thinking |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Change in cognitive function summary score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual processing speed summary score (mental activity group), executive function summary score (exercise group), other measures (e.g., leisure activity, physical performance, physical function, depressive symptoms, sleep quality) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 126 |
| Study Start Date: | August 2007 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Behavioral: Group 1
Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Behavioral: Group 2
Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
|
|
Active Comparator: 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.
|
Behavioral: Group 3
Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Behavioral: Group 4
Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
|
|
Experimental: 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.
|
Behavioral: Group 1
Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Behavioral: Group 3
Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
|
|
Active Comparator: 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.
|
Behavioral: Group 2
Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
Behavioral: Group 4
Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
|
Detailed Description:
SPECIFIC AIMS AND HYPOTHESES
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 64
- 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:
- Evidence of dementia (based on self-report, physician diagnosis or score < 19 on Telephone Interview for Cognitive Status)
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522899
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522899
Locations
| United States, California | |
| San Francisco Veterans Affairs Medical Center | |
| San Francisco, California, United States, 94121 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
Sponsors and Collaborators
University of California, San Francisco
Alzheimer's Association
Posit Science Corporation
YMCA of San Francisco
Investigators
| Principal Investigator: | Deborah E Barnes, PhD, MPH | University of California, San Francisco and San Francisco VA Medical Center |
More Information
No publications provided by University of California, San Francisco
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Deborah Barnes, Associate Professor, Psychiatry and Epidemiology & Biostatistics, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00522899 History of Changes |
| Other Study ID Numbers: | BarnesDeborahE-1, K01AG024069, IIRG-06-27306 |
| Study First Received: | August 28, 2007 |
| Last Updated: | April 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
aged exercise cognitive therapy dementia prevention |
ClinicalTrials.gov processed this record on March 03, 2015