{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,23]],"date-time":"2025-09-23T00:13:27Z","timestamp":1758586407035,"version":"3.44.0"},"reference-count":21,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2025,9,21]],"date-time":"2025-09-21T00:00:00Z","timestamp":1758412800000},"content-version":"unspecified","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"This study was supported by a grant from the Young Adult Clinical Research Project of Peking University First Hospital.","award":["2024YC05"],"award-info":[{"award-number":["2024YC05"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,8,29]]},"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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\u2014a 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>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\u2009min 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>This study protocol was registered at ClinicalTrials.gov (Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06795737\">NCT06795737<\/jats:ext-link>, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/\">https:\/\/www.clinicaltrials.gov\/<\/jats:ext-link>.) on 26 January 2025.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-102812","type":"journal-article","created":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T02:31:33Z","timestamp":1758508293000},"page":"e102812","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06795737","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Jing","family":"Ye","sequence":"first","affiliation":[{"name":"Peking University First Hospital, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4094-8931","authenticated-orcid":false,"given":"Lihua","family":"Zhao","sequence":"additional","affiliation":[{"name":"Peking University First Hospital, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yimeng","family":"Jiang","sequence":"additional","affiliation":[{"name":"Peking University First Hospital, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lihua","family":"Hu","sequence":"additional","affiliation":[{"name":"Peking University First Hospital, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lei","family":"Yang","sequence":"additional","affiliation":[{"name":"Peking University First Hospital, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuling","family":"Wang","sequence":"additional","affiliation":[{"name":"Peking University First Hospital, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenhui","family":"Ding","sequence":"additional","affiliation":[{"name":"Peking University First Hospital, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yimei","family":"Zheng","sequence":"additional","affiliation":[{"name":"Peking University First Hospital, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,9,21]]},"reference":[{"key":"2025092119301833000_15.9.e102812.1","first-page":"749","article-title":"Interpretation of the 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure","volume":"39","author":"Tang","year":"2023","journal-title":"J Clin Cardiol"},{"key":"2025092119301833000_15.9.e102812.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(19)32036-4"},{"key":"2025092119301833000_15.9.e102812.3","doi-asserted-by":"crossref","DOI":"10.1186\/s12872-018-0815-3","article-title":"Cost-of-illness studies in heart failure: a systematic review 2004-2016","volume":"18","author":"Lesyuk","year":"2018","journal-title":"BMC Cardiovasc Disord"},{"key":"2025092119301833000_15.9.e102812.4","doi-asserted-by":"crossref","unstructured":"McDonagh TA , Metra M , Adamo M , et al . 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). 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Eur J Heart Fail 2021;4\u2013131.","DOI":"10.1002\/ejhf.2333"},{"key":"2025092119301833000_15.9.e102812.5","doi-asserted-by":"crossref","first-page":"333","DOI":"10.3138\/ptc.2016-39GH","article-title":"Patients\u2019 Experiences of and Perspectives on Phase 1 Cardiac Rehabilitation after Coronary Artery Bypass Graft Surgery","volume":"69","author":"Maddocks","year":"2017","journal-title":"Physiother Can"},{"key":"2025092119301833000_15.9.e102812.6","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1097\/HCR.0000000000000374","article-title":"Cardiac Rehabilitation Utilization During an Acute Cardiac Hospitalization: A NATIONAL SAMPLE","volume":"39","author":"Pack","year":"2019","journal-title":"J Cardiopulm Rehabil Prev"},{"key":"2025092119301833000_15.9.e102812.7","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1016\/j.hfc.2021.01.007","article-title":"Exercise-Based Cardiac Rehabilitation Programs in Heart Failure Patients","volume":"17","author":"Patti","year":"2021","journal-title":"Heart Fail Clin"},{"key":"2025092119301833000_15.9.e102812.8","article-title":"Vulnerable period in heart failure: a window of opportunity for the optimization of treatment - a statement by Mexican experts","volume":"13","author":"Serrano","year":"2024","journal-title":"Drugs Context"},{"key":"2025092119301833000_15.9.e102812.9","first-page":"348","article-title":"Progress in definition and management of vulnerable phase after hospitalization for heart failure","volume":"34","author":"Chen","year":"2022","journal-title":"Chin Heart J"},{"key":"2025092119301833000_15.9.e102812.10","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2021-320131"},{"key":"2025092119301833000_15.9.e102812.11","doi-asserted-by":"crossref","first-page":"1338","DOI":"10.1002\/ejhf.1492","article-title":"Acute heart failure congestion and perfusion status \u2013 impact of the clinical classification on in\u2010hospital and long\u2010term outcomes; insights from the ESC\u2010EORP\u2010HFA Heart Failure Long\u2010Term Registry","volume":"21","author":"Chioncel","year":"2019","journal-title":"European J of Heart Fail"},{"key":"2025092119301833000_15.9.e102812.12","doi-asserted-by":"crossref","first-page":"1693","DOI":"10.2147\/PPA.S312200","article-title":"Burden and Quality of Life Among Female and Male Patients with Heart Failure in Europe: A Real-World Cross-Sectional Study","volume":"15","author":"Fonseca","year":"2021","journal-title":"Patient Prefer Adherence"},{"key":"2025092119301833000_15.9.e102812.13","first-page":"432","article-title":"Chinese expert consensus on standardized clinical application of 6-minute walk test","volume":"50","year":"2022","journal-title":"Zhonghua Xin Xue Guan Bing Za Zhi"},{"key":"2025092119301833000_15.9.e102812.14","doi-asserted-by":"crossref","first-page":"1646","DOI":"10.1016\/j.jamda.2020.09.038","article-title":"The Short Physical Performance Battery (SPPB): A Quick and Useful Tool for Fall Risk Stratification Among Older Primary Care Patients","volume":"22","author":"Welch","year":"2021","journal-title":"J Am Med Dir Assoc"},{"key":"2025092119301833000_15.9.e102812.15","article-title":"Assessment tools to evaluate Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) in older adults: A systematic review","volume":"34","author":"Pashmdarfard","year":"2020","journal-title":"Med J Islam Repub Iran"},{"key":"2025092119301833000_15.9.e102812.16","doi-asserted-by":"crossref","DOI":"10.1186\/s12877-020-01801-7","article-title":"A scoping review of the Clinical Frailty Scale","volume":"20","author":"Church","year":"2020","journal-title":"BMC Geriatr"},{"key":"2025092119301833000_15.9.e102812.17","unstructured":"Xian Liang W , Hong Wei L , Jing Yuan M . Items Screening of Modified Minnesota Cardiac Failure Life Quality Scale Based on Chinese Culture. J Tradit Chin Med 2016;22\u20134."},{"key":"2025092119301833000_15.9.e102812.18","doi-asserted-by":"crossref","DOI":"10.1136\/openhrt-2022-001965","article-title":"In-hospital electrical muscle stimulation for patients early after heart failure decompensation: results from a prospective randomised controlled pilot trial","volume":"9","author":"Poltavskaya","year":"2022","journal-title":"Open Heart"},{"key":"2025092119301833000_15.9.e102812.19","unstructured":"Jing Y , Li Hua Z , Yi Mei Z , et al . Effect of phase I exercise rehabilitation on patients with acute decompensated heart failure: a meta-analysis. 2025;6:226\u201332."},{"key":"2025092119301833000_15.9.e102812.20","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2023.12.024"},{"key":"2025092119301833000_15.9.e102812.21","first-page":"408","article-title":"Efficacy and safety of exercise rehabilitation in the vulnerable phase in patients with acute decompensated heart failure: A systematic review and meta-analysis","volume":"12","author":"Zhao","year":"2025","journal-title":"Int J Nurs Sci"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-102812","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T02:31:41Z","timestamp":1758508301000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-102812"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9]]},"references-count":21,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2025,9,21]]},"published-print":{"date-parts":[[2025,9]]}},"alternative-id":["10.1136\/bmjopen-2025-102812"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-102812","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9]]}}}