Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation

This study has been completed.
Sponsor:
Information provided by:
Summa Health System
ClinicalTrials.gov Identifier:
NCT00320905
First received: May 1, 2006
Last updated: July 19, 2010
Last verified: July 2010
  Purpose

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 Intervention
Cardiovascular Disease
Behavioral: Observational

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation

Resource links provided by NLM:


Further study details as provided by Summa Health System:

Enrollment: 70
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Observational
    No intervention
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Those with cardiovascular disease

Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320905

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

No publications provided

Responsible Party: Donna Waechter, Ph.D., Summa Health System
ClinicalTrials.gov Identifier: NCT00320905     History of Changes
Other Study ID Numbers: RP#05094
Study First Received: May 1, 2006
Last Updated: July 19, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014