Clinical trial NCT05726565: Impact of Cardiac Rehabilitation on Acute Heart Failure Patients With Cognitive Impairment
Official title: Impact of Cardiac Rehabilitation on Acute Heart Failure Patients With Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Systolic
Morality
Cognitive Impairment
Keywords: acute heart failure
cognitive screening
cardiac rehabilitation
cardiopulmonary exercise test
adverse outcomes
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 247
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.)

Eligibility criteria: 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.

Primary outcomes:
measure: composite of all-cause mortality or HF hospitalization
timeFrame: March, 2015 ~ May, 2021
Secondary outcomes:
measure: all-cause mortality
timeFrame: March, 2015 ~ May, 2021
measure: recurrent HF hospitalization
timeFrame: March, 2015 ~ May, 2021
measure: Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score
timeFrame: March, 2015 ~ May, 2021
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Heart Failure Center
Study officials:
References: