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

NCT ID: NCT05726565

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 247 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2022-07-30

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.)

Conditions

Heart Failure, Systolic; Morality; Cognitive Impairment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

multidisciplinary cardiac rehabilitation

Intervention Type: 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.

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.

multidisciplinary cardiac rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung Memorial Hospital Heart Failure Center

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

202200636B0

Identifier Type: -

Identifier Source: org_study_id