The Mental Activity and eXercise Trial for Seniors

Cognitive Impairment Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522899
• Other study ID #: BarnesDeborahE-1
• Secondary ID: K01AG024069IIRG-
• Status: Completed
• Phase: N/A
• First received: August 28, 2007
• Last updated: April 6, 2012
• Start date: August 2007
• Est. completion date: June 2011

Study information

• Verified date: April 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: June 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment

Intervention

Behavioral:
• Group 1
Aerobic exercise plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
• Group 2
Aerobic exercise plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.
• Group 3
Stretching/toning exercise group plus computer-based mental activity training: both 3 days/week, 60 minutes/session for 12 weeks.
• Group 4
Stretching/toning exercise group plus educational DVDs: both 3 days/week, 60 minutes/session for 12 weeks.

Locations

Country	Name	City	State
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Alzheimer's Association, National Institute on Aging (NIA), Posit Science Corporation, YMCA of San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive function summary score		12 weeks	No
Secondary	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	No