The Mental Activity and eXercise Trial for Seniors (MAX)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00522899 |
Recruitment Status :
Completed
First Posted : August 30, 2007
Last Update Posted : April 9, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cognitive Impairment | Behavioral: Group 1 Behavioral: Group 2 Behavioral: Group 3 Behavioral: Group 4 | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 126 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
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. |
- Change in cognitive function summary score [ Time Frame: 12 weeks ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522899
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 |
Principal Investigator: | Deborah E Barnes, PhD, MPH | University of California, San Francisco and San Francisco VA Medical Center |
Responsible Party: | Deborah Barnes, Associate Professor, Psychiatry and Epidemiology & Biostatistics, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00522899 |
Other Study ID Numbers: |
BarnesDeborahE-1 K01AG024069 ( U.S. NIH Grant/Contract ) IIRG-06-27306 ( Other Grant/Funding Number: Alzheimer's Association ) |
First Posted: | August 30, 2007 Key Record Dates |
Last Update Posted: | April 9, 2012 |
Last Verified: | April 2012 |
aged exercise cognitive therapy dementia prevention |
Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |