- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00871897
Examining the Cognitive Benefits of Cardiac Rehabilitation in People With Heart Failure (The CHF CaRe Study) (CHF CaRe)
Cognitive Benefits of Cardiac Rehabilitation in Heart Failure
Study Overview
Status
Conditions
Detailed Description
Over 5 million people in the United States have heart failure, and 500,000 more develop this condition each year. Up to 80% of people with heart failure experience cognitive functioning difficulties, including problems with memory, attention, and other thinking skills. People with heart failure often participate in a cardiac rehabilitation program, which is an individualized program that aims to improve a person's physical and mental health while dealing with a heart-related condition. Cardiac rehabilitation is different for each person, but it can include medical counseling on how to manage a heart condition and how to modify risk factors for further heart problems, including lowering blood pressure and cholesterol levels, stopping smoking, and losing weight. Nutritional counseling and an exercise program may also be a part of cardiac rehabilitation. Preliminary research has shown that people with heart failure who participate in a cardiac rehabilitation program may experience improved cognitive function. This is thought to be a result of increased blood flow to the brain and improved autonomic nervous system function, which is responsible for regulating various body functions. In this study, researchers will explore the relationship between heart failure and cognitive function, examine how cognitive function changes over time in heart failure patients, and evaluate how cardiac rehabilitation may affect cognitive function in older adults. Specifically, researchers will examine how physical activity and patterns of blood flow affect cognitive function.
This study will enroll people with heart failure who are participating in a 12-week cardiac rehabilitation program and people with heart failure who are not participating in a cardiac rehabilitation program. All participants will attend study visits at baseline, Week 12, and Month 12. At each study visit, participants will undergo neuropsychological testing, heart rate and blood pressure measurements, and a walking exercise test. They will also complete questionnaires to assess diet, physical activity, and stress levels. Participants will undergo an imaging procedure to measure blood flow in the neck and head, and some participants will also undergo a magnetic resonance imaging (MRI) procedure of their brain. For 1 week after each study visit, participants will wear a physical activity monitor. At Months 6 and 9, participants will complete questionnaires and mail these back to study researchers.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ohio
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Akron, Ohio, United States, 44309
- SUMMA Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Systolic heart failure confirmed by perfusion stress scan
Exclusion Criteria:
- Has a pacemaker
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cardiac Rehabilitation
People with heart failure who elect to participate in cardiac rehabilitation.
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No Cardiac Rehabiliation
People with heart failure who elect NOT to participate in cardiac rehabilitation.
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Collaborators and Investigators
Publications and helpful links
General Publications
- Walter FA, Gathright E, Redle JD, Gunstad J, Hughes JW. Depressive Symptoms are Associated with Heart Rate Variability Independently of Fitness: A Cross-Sectional Study of Patients with Heart Failure. Ann Behav Med. 2019 Oct 7;53(11):955-963. doi: 10.1093/abm/kaz006.
- Alosco ML, Spitznagel MB, van Dulmen M, Raz N, Cohen R, Sweet LH, Colbert LH, Josephson R, Hughes J, Rosneck J, Gunstad J. Cognitive function and treatment adherence in older adults with heart failure. Psychosom Med. 2012 Nov-Dec;74(9):965-73. doi: 10.1097/PSY.0b013e318272ef2a. Epub 2012 Oct 31.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 649
- R01HL089311 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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