The Mental Activity and eXercise Trial for Seniors (MAX)

• ClinicalTrials.gov Identifier: NCT00522899
• Recruitment Status: Completed
• First Posted: August 30, 2007
• Last Update Posted: April 9, 2012
• Sponsor: University of California, San Francisco
• 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: August 28, 2007
• First Posted Date: August 30, 2007
• Last Update Posted Date: April 9, 2012
• Study Start Date: August 2007
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 29, 2007): Change in cognitive function summary score [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (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 (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: The Mental Activity and eXercise Trial for Seniors
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Cognitive Impairment

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 6, 2012): 126
• Original Estimated Enrollment (submitted: August 29, 2007): 360
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00522899
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Deborah Barnes, University of California, San Francisco
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current

Collaborators

• Alzheimer's Association
• National Institute on Aging (NIA)
• Posit Science Corporation
• YMCA of San Francisco

Investigators

• 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