Cognitive ImpairmentMAXNCT00522899
The Mental Activity and eXercise Trial for Seniors
A study testing Group 1, Group 2 and Group 3 in people with Cognitive Impairment, run by University of California, San Francisco at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Group 1, Group 2 and Group 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Jun 2011
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
University of California, San Francisco
San Francisco, California, 94143
About this study
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
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.
Read the 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.
- Conditions
- Cognitive Impairment
- Being tested
- Group 1, Group 2, Group 3, Group 4
- Keywords
- aged, exercise, cognitive therapy, dementia, prevention
- Medical subject headings
- Cognitive Dysfunction, Motor Activity, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Behavioural
Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Group 2Behavioural
Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
Group 3Behavioural
Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Group 4Behavioural
Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | 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. Receives: Behavioral: Group 1; Behavioral: Group 2 |
| Stretching/toning | Active comparator | 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. Receives: Behavioral: Group 3; Behavioral: Group 4 |
| Computer-based mental activity training | Experimental | 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. Receives: Behavioral: Group 1; Behavioral: Group 3 |
| Educational DVD training | Active comparator | 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. Receives: Behavioral: Group 2; Behavioral: Group 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function summary score
Measured: 12 weeks
Secondary outcomes (1)
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association, National Institute on Aging (NIA), Posit Science Corporation, YMCA of San Francisco
- Responsible party
- Principal investigator, Deborah Barnes, University of California, San Francisco
- Investigators
- Deborah E Barnes, PhD, MPH, Principal investigator, University of California, San Francisco and San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522899
- Sponsor's protocol ID
- BarnesDeborahE-1
- Other IDs
- K01AG024069, IIRG-06-27306
- Acronym
- MAX
- Status last verified
- Apr 2012
- First submitted
- 28 Aug 2007
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23545598
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00522899
- Acronym / sponsor ID
- MAX / BarnesDeborahE-1
- Conditions
- Cognitive Impairment
- Keywords
- aged, exercise, cognitive therapy, dementia, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Alzheimer's Association, National Institute on Aging (NIA), Posit Science Corporation, YMCA of San Francisco
- Study start
- Aug 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Aug 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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Group 1, Behavioral: Group 2Study-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. |
| Stretching/toning | Active comparator | Behavioral: Group 3, Behavioral: Group 4Study-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. |
| Computer-based mental activity training | Experimental | Behavioral: Group 1, Behavioral: Group 3Computer-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. |
| Educational DVD training | Active comparator | Behavioral: Group 2, Behavioral: Group 4Watching 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
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 |
|---|---|---|
| Group 1Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks. | Behavioural | Aerobic exercise, Computer-based mental activity training |
| Group 2Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks. | Behavioural | Aerobic exercise, Educational DVD training |
| Group 3Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks. | Behavioural | Computer-based mental activity training, Stretching/toning |
| Group 4Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks. | Behavioural | Educational DVD training, Stretching/toning |
Primary outcome
Change in cognitive function summary score
Time frame: 12 weeks
1 secondary outcome
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
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 9 Apr 2012.
- Derived from this study: PubMed 23545598Barnes 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.
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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.
Deborah E Barnes, PhD, MPH principal investigator
University of California, San Francisco and San Francisco VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1, Group 2 and Group 3 in people with Cognitive Impairment, run by University of California, San Francisco at 2 sites 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 20 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 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in cognitive function summary score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00522899, which also lists 1 linked publication.
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 9 Apr 2012; AzTrials last refreshed its copy on 31 Oct 2026.