NCT00522899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 9, 2012

Status Verified

April 1, 2012

Enrollment Period

2.3 years

First QC Date

August 28, 2007

Last Update Submit

April 6, 2012

Conditions

Cognitive Impairment

Keywords

agedexercisecognitive therapydementiaprevention

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive function summary score

    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)

    12 weeks

Study Arms (4)

Aerobic exercise

EXPERIMENTAL

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 1Behavioral: Group 2

Stretching/toning

ACTIVE COMPARATOR

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 3Behavioral: Group 4

Computer-based mental activity training

EXPERIMENTAL

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 1Behavioral: Group 3

Educational DVD training

ACTIVE COMPARATOR

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 2Behavioral: Group 4

Interventions

Group 1BEHAVIORAL

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

Aerobic exerciseComputer-based mental activity training
Group 2BEHAVIORAL

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

Aerobic exerciseEducational DVD training
Group 3BEHAVIORAL

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

Computer-based mental activity trainingStretching/toning
Group 4BEHAVIORAL

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

Educational DVD trainingStretching/toning

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • Barnes DE, Santos-Modesitt W, Poelke G, Kramer AF, Castro C, Middleton LE, Yaffe K. The Mental Activity and eXercise (MAX) trial: a randomized controlled trial to enhance cognitive function in older adults. JAMA Intern Med. 2013 May 13;173(9):797-804. doi: 10.1001/jamainternmed.2013.189.

    PMID: 23545598DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionMotor ActivityDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Deborah E Barnes, PhD, MPH

    University of California, San Francisco and San Francisco VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Psychiatry and Epidemiology & Biostatistics

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 30, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2009

Study Completion

June 1, 2011

Last Updated

April 9, 2012

Record last verified: 2012-04

Locations

US(2)