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Clinical Trials/NCT05726565
NCT05726565
Completed
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country247 target enrollmentMarch 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure, Systolic
Sponsor
Chang Gung Memorial Hospital
Enrollment
247
Locations
1
Primary Endpoint
composite of all-cause mortality or HF hospitalization
Status
Completed
Last Updated
3 years ago

Overview

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.)

Registry
clinicaltrials.gov
Start Date
March 1, 2015
End Date
July 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

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.
  • Cannot cooperate with all functional studies.

Outcomes

Primary Outcomes

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

  • all-cause mortality(March, 2015 ~ May, 2021)
  • recurrent 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(March, 2015 ~ May, 2021)

Study Sites (1)

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