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Completed

NCT Number: NCT05726565

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

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.

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Key information

Conditions

Heart Failure, Systolic Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Heart Diseases Heart Failure Mental Disorders Morality Neurocognitive Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital Heart Failure Center

Kaohsiung City, 83341, Taiwan

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

multidisciplinary cardiac rehabilitation

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. recurrent HF hospitalization

    Time frame: March, 2015 ~ May, 2021

    Number of participants that had an occurrence of HF hospitalization

  3. 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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Feb 14, 2023
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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