CClinicalTrials.gg
CompletedNCT00522899MAXUpdated Apr 9, 2012

The Mental Activity and eXercise Trial for Seniors

An interventional study of Group 1 and Group 2 in Cognitive Impairment, sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2012-04-09.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cognitive Impairment

Keywords

  • aged
  • exercise
  • cognitive therapy
  • dementia
  • prevention
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 126 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
126 participants (actual)

Study arms

  • 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 · Behavioral: Group 2

  • 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 · Behavioral: Group 4

  • 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 · Behavioral: Group 3

  • 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 · Behavioral: Group 4

Interventions

  • BehavioralGroup 1

    Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.

  • BehavioralGroup 2

    Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.

  • BehavioralGroup 3

    Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.

  • BehavioralGroup 4

    Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Change in cognitive function summary score

    Time frame: 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)

    Time frame: 12 weeks

07

Study locations

2 sites
  • San Francisco Veterans Affairs Medical Center
    San Francisco, California 94121, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00522899
Lead sponsor
University of California, San Francisco
Collaborators
Alzheimer's Association, National Institute on Aging (NIA), Posit Science Corporation, YMCA of San Francisco
Responsible party
Deborah Barnes (Associate Professor, Psychiatry and Epidemiology & Biostatistics, University of California, San Francisco) — Principal investigator
First posted
Aug 30, 2007
Start date
Aug 2007
Primary completion
Dec 2009
Completion
Jun 2011
Last update
Apr 9, 2012

Study contacts

Deborah E Barnes, PhD, MPH
principal investigator · University of California, San Francisco and San Francisco VA Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion