The Effects of Mental Activity and Exercise on Cognitive Function in Older Adults Who Self-Report a Recent Decline in Memory or Thinking
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 126
- Locations
- 2
- Primary Endpoint
- Change in cognitive function summary score
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Group 1 (Behavioral)
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.
Intervention: Group 2 (Behavioral)
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.
Intervention: Group 3 (Behavioral)
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.
Intervention: Group 4 (Behavioral)
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.
Intervention: Group 1 (Behavioral)
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.
Intervention: Group 3 (Behavioral)
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.
Intervention: Group 2 (Behavioral)
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.
Intervention: Group 4 (Behavioral)
Outcomes
Primary Outcomes
Change in cognitive function summary score
Time Frame: 12 weeks
Secondary Outcomes
- 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)
Investigators
Deborah Barnes
Associate Professor, Psychiatry and Epidemiology & Biostatistics
University of California, San Francisco