Clinical trial NCT00522899: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: aged
exercise
cognitive therapy
dementia
prevention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
name: National Institute on Aging (NIA)
name: Posit Science Corporation
name: YMCA of San Francisco
First posted: 2007-08-30
Enrollment: 126
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in cognitive function summary score
timeFrame: 12 weeks
Secondary outcomes:
measure: 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)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco and San Francisco VA Medical Center
name: Deborah E Barnes, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.