The Mental Activity and eXercise Trial for Seniors

Study Overview
=================
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.

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

Conditions
-----------------
Cognitive Impairment

Intervention / Treatment
-----------------
* Behavioral: Group 1
* Behavioral: Group 2
* Behavioral: Group 3
* Behavioral: Group 4


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise<br>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. | Behavioral: Group 1<br>* Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.<br>Behavioral: Group 2<br>* Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.<br>|
| Active Comparator: Stretching/toning<br>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. | Behavioral: Group 3<br>* Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.<br>Behavioral: Group 4<br>* Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.<br>|
| Experimental: Computer-based mental activity training<br>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. | Behavioral: Group 1<br>* Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.<br>Behavioral: Group 3<br>* Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.<br>|
| Active Comparator: Educational DVD training<br>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. | Behavioral: Group 2<br>* Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.<br>Behavioral: Group 4<br>* Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function summary score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aged, exercise, cognitive therapy, dementia, prevention