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Clinical Trials/NCT00522899
NCT00522899
Completed
Not Applicable

The Effects of Mental Activity and Exercise on Cognitive Function in Older Adults Who Self-Report a Recent Decline in Memory or Thinking

University of California, San Francisco2 sites in 1 country126 target enrollmentAugust 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
University of California, San Francisco
Enrollment
126
Locations
2
Primary Endpoint
Change in cognitive function summary score
Status
Completed
Last Updated
14 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deborah Barnes

Associate Professor, Psychiatry and Epidemiology & Biostatistics

University of California, San Francisco

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

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)

Study Sites (2)

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