Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00320905
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : July 20, 2010
Information provided by:
Summa Health System

Brief Summary:
The proposed study will be the first to examine whether changes in blood flow patterns within the brain account for the possible cognitive benefits of CR. A clearer understanding of this possibility may provide key insight into the way CVD affects the brain, help identify effective treatments, help a greater number of patients return to work, and improve quality of life.

Condition or disease Intervention/treatment
Cardiovascular Disease Behavioral: Observational

Detailed Description:
Based on recent patient referrals, we expect that 30 participants will subsequently enroll in CR and 30 will not. CR patients will complete standardized neuropsychological tests (45-60 minutes) and Transcranial Doppler (30-40 minutes) during their first and last week in the CR program. Patients who do not enroll in CR will undergo testing at similar intervals to serve as a matched control group. Standard medical records will be collected for participants in both groups to obtain demographic and medical information. CR-specific medical records will also be collected to obtain information about possible mechanisms for cognitive benefits (e.g. improved stress test performance, reduced blood pressure, etc.). All participants will be compensated for their time.

Study Type : Observational
Actual Enrollment : 70 participants
Time Perspective: Prospective
Official Title: Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation
Study Start Date : March 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Behavioral: Observational
    No intervention

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Those with cardiovascular disease

Inclusion Criteria:

- 50 to 85 years of age, able to communicate in English, history of heart disease

Exclusion Criteria:

- history of significant neurological disorders, such as stroke, Alzheimer's disease, or severe head injury significant psychological problems such as schizophrenia or bipolar disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00320905

United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Summa Health System
Study Director: Richard A Josephson, MD Summa Health System

Responsible Party: Donna Waechter, Ph.D., Summa Health System Identifier: NCT00320905     History of Changes
Other Study ID Numbers: RP#05094
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: July 20, 2010
Last Verified: July 2010

Keywords provided by Summa Health System:
Cardiac Rehabilitation
Cognitive functioning
Cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases