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The Mental Activity and eXercise Trial for Seniors (MAX)

This study has been completed.
Sponsor:
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

August 28, 2007
April 6, 2012
August 2007
December 2009   (final data collection date for primary outcome measure)
Change in cognitive function summary score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in cognitive function summary score [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00522899 on ClinicalTrials.gov Archive Site
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 ]
Visual processing speed summary score (mental activity group), executive function summary score (exercise group), other measures (CHAMPS, Senior Fitness Test, GDS, SF-36, IADL, PSQI) [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
The Mental Activity and eXercise Trial for Seniors
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Cognitive Impairment
  • 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.
  • 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: 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Behavioral: Group 2
    • Behavioral: Group 4
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
June 2011
December 2009   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00522899
BarnesDeborahE-1, K01AG024069, IIRG-06-27306
Yes
Deborah Barnes, University of California, San Francisco
University of California, San Francisco
  • Alzheimer's Association
  • National Institute on Aging (NIA)
  • Posit Science Corporation
  • YMCA of San Francisco
Principal Investigator: Deborah E Barnes, PhD, MPH University of California, San Francisco and San Francisco VA Medical Center
University of California, San Francisco
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP