Examining the Cognitive Benefits of Cardiac Rehabilitation in People With Heart Failure (The CHF CaRe Study)

Heart Failure Clinical Trial

— CHF CaRe  

Official title:

Cognitive Benefits of Cardiac Rehabilitation in Heart Failure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00871897
• Other study ID #: 649
• Secondary ID: R01HL089311
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 27, 2009
• Last updated: July 28, 2016
• Start date: April 2009
• Est. completion date: June 2013

Study information

• Verified date: December 2009
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

People with heart failure may experience problems with cognitive function, including memory and attention. Cardiac rehabilitation, which is an individualized program for heart failure patients that aims to improve their heart health, may also improve cognitive function. This study will examine the relationship between heart failure and cognitive function and how undergoing cardiac rehabilitation affects cognitive function in older adults with heart failure.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Systolic heart failure confirmed by perfusion stress scan

Exclusion Criteria:

• Has a pacemaker

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,