The Mental Activity and eXercise Trial for Seniors (MAX)
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ClinicalTrials.gov Identifier: NCT00522899 |
Recruitment Status :
Completed
First Posted : August 30, 2007
Last Update Posted : April 9, 2012
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Tracking Information | ||||
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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 |
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 |
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 |
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. |
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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 |
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Condition ICMJE | Cognitive Impairment | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
126 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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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 |
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Investigators ICMJE |
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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 |