Skip to main content
OpenTrials
Completed

NCT Number: NCT00522899

The Mental Activity and eXercise Trial for Seniors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Veterans Affairs Medical Center, San Francisco, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1

Behavioral

Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.

Group 2

Behavioral

Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.

Group 3

Behavioral

Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.

Group 4

Behavioral

Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.

Primary outcomes

  1. Change in cognitive function summary score

    Time frame: 12 weeks

Secondary outcomes

  1. 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)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Alzheimer's Association
  • National Institute on Aging (NIA)
  • Posit Science Corporation
  • YMCA of San Francisco

Registry information

Official study title

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

Acronym: MAX

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Aug 30, 2007
Registry last updated
Apr 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.