Back to resultsThe Mental Activity and eXercise Trial for Seniors (MAX)
Primary Purpose
Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 1
Group 2
Group 3
Group 4
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Impairment focused on measuring aged, exercise, cognitive therapy, dementia, prevention
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
- 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
Sites / Locations
- San Francisco Veterans Affairs Medical Center
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Aerobic exercise
Stretching/toning
Computer-based mental activity training
Educational DVD training
Arm Description
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.
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 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.
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.
Outcomes
Primary Outcome Measures
Change in cognitive function summary score
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00522899
First Posted
August 28, 2007
Last Updated
April 6, 2012
Sponsor
University of California, San Francisco
Collaborators
Alzheimer's Association, National Institute on Aging (NIA), Posit Science Corporation, YMCA of San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00522899
Brief Title
The Mental Activity and eXercise Trial for Seniors
Acronym
MAX
Official Title
The Effects of Mental Activity and Exercise on Cognitive Function in Older Adults Who Self-Report a Recent Decline in Memory or Thinking
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
Alzheimer's Association, National Institute on Aging (NIA), Posit Science Corporation, YMCA of San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
aged, exercise, cognitive therapy, dementia, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching/toning
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Computer-based mental activity training
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational DVD training
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Group 1
Intervention Description
Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Group 2
Intervention Description
Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Group 3
Intervention Description
Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Group 4
Intervention Description
Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
Primary Outcome Measure Information:
Title
Change in cognitive function summary score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah E Barnes, PhD, MPH
Organizational Affiliation
University of California, San Francisco and San Francisco VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Veterans Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23545598
Citation
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.
Results Reference
derived
Learn more about this trial
The Mental Activity and eXercise Trial for Seniors
We'll reach out to this number within 24 hrs