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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
Sponsor:
Collaborators:
Alzheimer's Association
National Institute on Aging (NIA)
Posit Science Corporation
YMCA of San Francisco
Information provided by (Responsible Party):
Deborah Barnes, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 28, 2007
First Posted Date  ICMJE August 30, 2007
Last Update Posted Date April 9, 2012
Study Start Date  ICMJE August 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
Change in cognitive function summary score [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2007)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Mental Activity and eXercise Trial for Seniors
Official Title  ICMJE The Effects of Mental Activity and Exercise on Cognitive Function in Older Adults Who Self-Report a Recent Decline in Memory or Thinking
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cognitive Impairment
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2012)
126
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2007)
360
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00522899
Other Study ID Numbers  ICMJE BarnesDeborahE-1
K01AG024069 ( U.S. NIH Grant/Contract )
IIRG-06-27306 ( Other Grant/Funding Number: Alzheimer's Association )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Deborah Barnes, University of California, San Francisco
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Alzheimer's Association
  • National Institute on Aging (NIA)
  • Posit Science Corporation
  • YMCA of San Francisco
Investigators  ICMJE
Principal Investigator: Deborah E Barnes, PhD, MPH University of California, San Francisco and San Francisco VA Medical Center
PRS Account University of California, San Francisco
Verification Date April 2012

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