Effectiveness and safety of exercise-based cardiac rehabilitation (ExCR) during the vulnerable period in patients with acute decompensated heart failure (ADHF): a randomised controlled trial protocol.

backgroundAcute decompensated heart failure (ADHF), characterised by rapid deterioration of cardiac function, imposes substantial clinical and economic burdens due to high mortality (10%), frequent rehospitalisations (30% within 3 months) and impaired health-related quality of life. While exercise-based cardiac rehabilitation (ExCR) is a guideline-recommended intervention for stable heart failure, its utilisation remains critically low (11%) in ADHF populations, particularly during the vulnerable period spanning 90 days post-discharge-a high-risk phase marked by elevated mortality and morbidity. Current evidence gaps persist regarding optimal ExCR timing, dosage and efficacy during this critical window. This randomised controlled trial investigates the feasibility and impact of early ExCR initiation in the ADHF vulnerable period, evaluating outcomes in physical capacity, cardiac function and quality of life to inform evidence-based exercise protocols for this high-risk population.

methodsThis prospective, non-inferiority, randomised controlled trial will recruit 88 patients with ADHF. Participants will be randomised 1:1 to a 12-week personalised ExCR group or a traditional health education-based CR control group. Assessments will occur at baseline and 1, 2 and 3 months. The primary outcome is the change in 6 min walk distance post-intervention. Secondary outcomes include changes in grip strength, New York Heart Association Classification(NYHA class), brain natriuretic peptide, left ventricular ejection fraction, hospital stay, Short Physical Performance Battery score, Activities of Daily Living, Minnesota Living with Heart Failure Questionnaire score, and frailty status. Safety measures include all-cause readmission and mortality within 3 months post-discharge, as well as adverse events during the trial. ETHICS AND DISSEMINATION: The study protocol was approved by the Peking University First Hospital Ethics Committee (Approval No. 2024yan180-002) in accordance with the Declaration of Helsinki. All participants will provide written informed consent prior to enrolment. The findings will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: This study protocol was registered at ClinicalTrials.gov (Identifier: NCT06795737, https://www. CLINICALTRIALS: gov/.) on 26 January 2025.