Heart FailureCHF CaReNCT00871897
Examining the Cognitive Benefits of Cardiac Rehabilitation in People With Heart Failure (The CHF CaRe Study)
An observational study of Heart Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Heart Failure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with heart failure
Who may be able to join
- Systolic heart failure confirmed by perfusion stress scan
Who cannot join
- Has a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Benefits of Cardiac Rehabilitation in Heart Failure
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.
Read the 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).
- Conditions
- Heart Failure
- Keywords
- Neuropsychology, Cardiac Rehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation | People with heart failure who elect to participate in cardiac rehabilitation. | |
| No Cardiac Rehabiliation | People with heart failure who elect NOT to participate in cardiac rehabilitation. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- John Gunstad, PhD, Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871897
- Sponsor's protocol ID
- 649
- Other IDs
- R01HL089311
- Acronym
- CHF CaRe
- Status last verified
- Dec 2009
- First submitted
- 27 Mar 2009
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30958884Alosco 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.
PubMed 23115344
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Benefits of Cardiac Rehabilitation in Heart Failure
- ClinicalTrials.gov ID
- NCT00871897
- Acronym / sponsor ID
- CHF CaRe / 649
- Conditions
- Heart Failure
- Keywords
- Neuropsychology, Cardiac Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation | – | –People with heart failure who elect to participate in cardiac rehabilitation. |
| No Cardiac Rehabiliation | – | –People with heart failure who elect NOT to participate in cardiac rehabilitation. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure
Key inclusion criteria (1 listed)
- Systolic heart failure confirmed by perfusion stress scan
Key exclusion criteria (1 listed)
- Has a pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 30958884Walter 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.
- Derived from this study: PubMed 23115344Alosco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Gunstad, PhD principal investigator
Kent State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00871897, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.