Impact of Cardiac Rehabilitation on Acute Heart Failure Patients With Cognitive Impairment

February 15, 2023 updated by: Chang Gung Memorial Hospital
In heart failure patients, neuropsychological disorders have been prospectively linked to frequent hospitalizations, recurrent cardiac events, and mortality. Cognitive dysfunction is also a frequent comorbidity in heart failure (HF) patients. The benefit of cardiac rehabilitation between patients with cognitive dysfunction and patients without cognitive dysfunction is unknown. Investigators hypothesize that patients with cognitive dysfunction benefit more from cardiac rehabilitation programs than patients without cognitive dysfunction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Investigators retrospectively reviewed HF patients discharged from acute HF hospitalizations between March 2015 and May 2021 at the heart failure center, Kaohsiung Chang Gung Memorial Hospital. Cognitive function was assessed with the Luria-Nebraska Neuropsychological Battery-Screening test (LNNB-S) Chinese version by an experienced psychologist. Participants may have cognitive impairment when their LNNB-S >=10. A heart failure disease management program was delivered to all patients before discharge, including an HF specialist nurse education program, dietitian consultation, physiatrist consultation, and psychologist consultation and assessment. Participants were advised to receive phase II cardiac rehabilitation (CR) after the cardiopulmonary exercise test (CPET) within one month. Moderate continuous aerobic exercise training was prescribed individually according to the CPET result. Participants who received at least one exercise session of phase II CR were considered as receiving CR. Other participants were considered non-receiving CR. Kaplan-Meier curves and log-rank test were constructed to compare the composite endpoint and all-causes mortality in four groups (Group a: Candidates without cognitive impairment and receiving CR. Group b: Candidates without cognitive impairment and not-receiving CR. Group c: Candidates with cognitive impairment and receiving CR. Group d: Candidates with cognitive impairment and not-receiving CR.)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
247

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 83341
        • Chang Gung Memorial Hospital Heart Failure Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Investigators retrospectively reviewed 247 HF patients who were discharged from an acute HF hospitalization. LNNB-S was assessed in all patients. Multivariate Cox Regression by enter method was used to determine significant predictors for all-cause mortality and composite endpoints. Kaplan-Meier curves and log-rank test were constructed to compare the composite endpoint and all-causes mortality according to cognitive impairment and receiving CR.

Description

Inclusion Criteria:

  • acute HF patients with reduced ejection fraction (left ventricular ejection fraction, LVEF <=40%) and discharged alive from the hospital.
  • Completed cognitive and psychological functional assessment.
  • Aged >= 20 years of age, male or female.
  • Received heart failure disease management coordinated by an HF specialist nurse as described before.

Exclusion Criteria:

  • Estimated survival time < 6 months.
  • Long-term bedridden for more than 3 months.
  • Terminal heart status. 4. Cannot cooperate with all functional studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
LNNB-S >=10
As one of the core components of multidisciplinary CR, psychiatrist and psychologist consultation was delivered to all patients. Cognitive function was assessed with the Luria-Nebraska Neuropsychological Battery-Screening test (LNNB-S) Chinese version by an experienced psychologist. The evaluation would be completed during admission. The initial LNNB was condensed to fifteen items for the screen test by Golden. LNNB-S Chinese version focuses on 3 domains, including number calculation, cognitive function, and rhythm control. In our participants' cohort, investigators choose LNNB-S >=10 as a cutoff point. That is, participants may have cognitive impairment when their LNNB-S >=10.
Other: multidisciplinary cardiac rehabilitation
A heart failure disease management program was delivered to all patients before discharge, including an HF specialist nurse education program, dietitian consultation, physiatrist consultation, and psychologist consultation and assessment. Participants were advised to receive phase II CR after the CPET within one month. Moderate continuous aerobic exercise training was prescribed individually according to the CPET result.4 The training intensity was within 10 beats of the anaerobic threshold or 40-60% of peak VO2. The training intensity was gradually increased fortnightly as tolerated (Borg's scale of 12-14). Phase II CR consisted of 12 weeks of 36 sessions in the entire course. Patients who received at least one exercise session were considered as receiving CR. Other patients were considered non-receiving CR.
LNNB-S <10
As one of the core components of multidisciplinary CR, psychiatrist and psychologist consultation was delivered to all patients. Cognitive function was assessed with the Luria-Nebraska Neuropsychological Battery-Screening test (LNNB-S) Chinese version by an experienced psychologist. The evaluation would be completed during admission. The initial LNNB was condensed to fifteen items for the screen test by Golden. LNNB-S Chinese version focuses on 3 domains, including number calculation, cognitive function, and rhythm control. In our participants' cohort, investigators choose LNNB-S >=10 as a cutoff point. That is, participants may have cognitive impairment when their LNNB-S >=10.
Other: multidisciplinary cardiac rehabilitation
A heart failure disease management program was delivered to all patients before discharge, including an HF specialist nurse education program, dietitian consultation, physiatrist consultation, and psychologist consultation and assessment. Participants were advised to receive phase II CR after the CPET within one month. Moderate continuous aerobic exercise training was prescribed individually according to the CPET result.4 The training intensity was within 10 beats of the anaerobic threshold or 40-60% of peak VO2. The training intensity was gradually increased fortnightly as tolerated (Borg's scale of 12-14). Phase II CR consisted of 12 weeks of 36 sessions in the entire course. Patients who received at least one exercise session were considered as receiving CR. Other patients were considered non-receiving CR.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
composite of all-cause mortality or HF hospitalization
Time Frame: March, 2015 ~ May, 2021
Number of participants that had an occurrence of the mortality which is defined as all-cause mortality or occurrence of HF hospitalization
March, 2015 ~ May, 2021

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: March, 2015 ~ May, 2021
Number of participants that had occurrence of the mortality which is defined as all-cause mortality
March, 2015 ~ May, 2021
recurrent HF hospitalization
Time Frame: March, 2015 ~ May, 2021
Number of participants that had an occurrence of HF hospitalization
March, 2015 ~ May, 2021
Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score
Time Frame: March, 2015 ~ May, 2021
Change from baseline to Month 6 and month 12 for the Kansas City Cardiomyopathy Questionnaire short form (KCCQ12) clinical summary score. KCCQ12 is a 12-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ12 clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
March, 2015 ~ May, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202200636B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data sharing plans will be discussed with other investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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