The Mental Activity and eXercise Trial for Seniors

Not Applicable

Completed

• Conditions: Cognitive Impairment
• Interventions: Behavioral: Group 1; Behavioral: Group 3; Behavioral: Group 2; Behavioral: Group 4

• Registration Number: NCT00522899
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-28
• Study First Submitted QC: 2007-08-29
• Study First Posted: 2007-08-30
• Primary Completion: 2009-12
• Study Completion: 2011-06
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-06
• Last Update Posted: 2012-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Aerobic exercise	Group 1	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.
Aerobic exercise	Group 2	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.
Stretching/toning	Group 3	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.
Stretching/toning	Group 4	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.
Computer-based mental activity training	Group 1	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.
Computer-based mental activity training	Group 3	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.
Educational DVD training	Group 2	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.
Educational DVD training	Group 4	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.

Primary Outcome Measures

Name	Time	Method
Change in cognitive function summary score	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

San Francisco Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States