The Mental Activity and eXercise Trial for Seniors (MAX)

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	Complete list of historical versions of study NCT00522899 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	65 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Deborah Barnes, University of California, San Francisco
Study Sponsor ICMJE	University of California, San Francisco
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