{
  "abstract": "Introduction Acute decompensated heart failure (ADHF) is associated with high mortality rates and significant decline in physical function following hospitalisation. Although exercise-based cardiac rehabilitation is recognised as a key component of comprehensive heart failure management, clinical evidence supporting its application in patients with ADHF remains limited. The trial aims to evaluate the efficacy and safety of an early initiated comprehensive rehabilitation in patients with ADHF.Methods and analysis This is a prospective, multicentre, randomised, open-label, parallel-group clinical trial. A total of 140 patients hospitalised with ADHF will be enrolled and randomised in a 1:1 ratio to receive either comprehensive rehabilitation intervention or attention control. The intervention group will receive a supervised, 6-week structured comprehensive rehabilitation programme consisting of progressive balance, endurance, strength and inspiratory muscle training. Rehabilitation therapy commences after admission and continues into the outpatient period with a total of 18 sessions. The control group will receive standard usual care supplemented by fortnightly non-rehabilitation-related contact from study personnel to control for attention. Coprimary outcomes are changes in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score and in maximum inspiratory pressure expressed as a percentage of predicted value (PImax%pred) at 6 weeks postrandomisation. Secondary outcomes include changes in the Short Physical Performance Battery score, frailty phenotype, pulmonary function tests and 6-month all-cause rehospitalisation.Ethics and dissemination The Early Comprehensive Rehabilitation in patients with ADHF (EACH-ADHF) trial was granted by the Medical Research Ethics Committee of Guangdong Provincial People’s Hospital (KY-Q-2022-487). Findings will be disseminated to patients, clinicians and commissioning groups through peer-reviewed publication.Trial registration number NCT06161987.",
  "authors": [
    {
      "affiliations": [
        "Department of Cardiac Rehabilitation, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China"
      ],
      "name": "Mingyu Xu"
    },
    {
      "affiliations": [
        "Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China"
      ],
      "name": "Jinna Chang"
    },
    {
      "affiliations": [
        "Department of Cardiac Rehabilitation, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China"
      ],
      "name": "Lan Guo"
    },
    {
      "affiliations": [
        "Department of Cardiac Rehabilitation, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China"
      ],
      "name": "Bingqing Bai"
    },
    {
      "affiliations": [
        "Department of Cardiac Rehabilitation, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China"
      ],
      "name": "Rou Wang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Yuebei People’s Hospital Affiliated to Shantou University School of Medicine, Shaoguan, China"
      ],
      "name": "Xiangyang Liu"
    },
    {
      "affiliations": [
        "Department of Cardiology, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China"
      ],
      "name": "Qian Du"
    },
    {
      "affiliations": [
        "Department of Cardiology, The Affiliated Dongguan Songshan Lake Central Hospital, Guangdong Medical University, Dongguan, China"
      ],
      "name": "Ying Mao"
    },
    {
      "affiliations": [
        "The Second Affiliated Hospital of Shantou University Medical College, Shantou, China"
      ],
      "name": "Ailing Xue"
    },
    {
      "affiliations": [
        "Binhaiwan Central Hospital of Dongguan, Dongguan, China"
      ],
      "name": "Minting Su"
    },
    {
      "affiliations": [
        "Department of Cardiology, The First Affiliated Hospital of Shantou University Medical College, Shantou, China"
      ],
      "name": "Yanping Wang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine (Zhongshan Hospital of Traditional Chinese Medicine), Zhongshan, China"
      ],
      "name": "Kaixuan Lin"
    },
    {
      "affiliations": [
        "Department of Cardiac Rehabilitation, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China",
        "Guangdong Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China"
      ],
      "name": "Huan Ma"
    }
  ],
  "title": "Protocol for EACH-ADHF trial: efficacy and safety of early comprehensive rehabilitation in patients with acute decompensated heart failure – a multicentre, randomised controlled trial",
  "uid": "9e717905-2060-5a20-a86a-7833b638bc0d"
}