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

作者：Jing Ye, Lihua Zhao, Yimeng Jiang, Lihua Hu, Lei Yang, Yuling Wang, Wenhui Ding, Yimei Zheng · 发表于：BMJ Open · 年份：2025 · DOI：10.1136/bmjopen-2025-102812 · 研究领域：Cardiovascular and exercise physiology、Cardiac Health and Mental Health、Heart Failure Treatment and Management

BACKGROUND: Acute 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. METHODS: This 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 pep...