ExCR's Effects and Safety in Vulnerable ADHF Patients

Official title

Effectiveness and Safety of Exercise-based Cardiac Rehabilitation (ExCR) During the Vulnerable Period in Patients With Acute Decompensated Heart Failure (ADHF): A Randomized Controlled Trial

Overview

Exercise-based cardiac rehabilitation has become a key component of the comprehensive care system for patients with stable heart failure (HF). However, due to hemodynamic instability and functional decline in early ADHF, most HF rehab studies exclude current/recent ADHF exacerbations. Currently, ADHF management strategies lack robust evidence, and the timing, duration, and frequency of exercise interventions need further validation globally. This study aims to address the following issues: Develop an exercise management program for ADHF patients, verify its feasibility, and determine the safety and applicability of early exercise rehabilitation; Evaluate the improvement of participants in terms of physical function, cardiac function, and quality of life. The research team will compare the formulated exercise rehabilitation program with conventional rehabilitation guidance to verify its feasibility and effectiveness. Participants will: Physicians and rehabilitation therapists will comprehensively assess the participants' conditions to determine the start time of rehabilitation training. Based on the patients' cardiac function, muscle strength, and heart failure-related clinical indicators, rehabilitation training is divided into two stages (the first stage is early in-hospital training, and the second stage is self-directed training after discharge). Exercise types mainly include respiratory training, bed activities, rehabilitation pedaling, and resistance training. Rehabilitation therapists and nurses will monitor participants' vital signs during the exercise process and choose the appropriate exercise intensity based on the participants' level of fatigue. The exercise rehabilitation program will be evaluated and adjusted every two weeks for a total period of 12 weeks. At the time of enrollment, discharge, two weeks after discharge, and four weeks after discharge, participants will need to complete questionnaires, including demographic and disease condition surveys, grip strength tests, Activities of Daily Living (ADL) scales, Short Physical Performance Battery (SPPB) scales, Minnesota Living with Heart Failure Questionnaire (MLHFQ) scales, and 6-minute walk tests, etc.

Interventions

• Behavioral Exercise rehabilitation
  The experimental group's protocol consists of two stages: in-hospital Phase I and post-discharge self-training. For Phase I, cardiac and rehab specialists assess NYHA classification, muscle strength, and mobility to create an exercise plan, supervised by therapists and nurses. Phase II involves twice-weekly outpatient rehab for 24 sessions and weekly remote guidance with WeChat and wristbands to track vitals, totaling 12 remote sessions. Exercise prescriptions are customized based on 6MWTD outco
• Behavioral Conventional rehabilitation
  Health Education: Nurses provide manuals on heart failure causes, treatment, diet, exercise (detailing frequency, intensity, duration, types, and safety), and self-monitoring to control group patients. Outpatient Follow-up: Post-discharge, heart failure patients have follow-ups at 2 weeks, 1 month, 2 months, and 3 months. A multidisciplinary team of doctors, pharmacists, and nurses handles these, with doctors for assessment, pharmacists for medication education, and nurses for self-care assessm

Primary outcome measures

• Change in the 6-minute walking test distance [Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.]

Secondary outcome measures (9)

• Left Ventricular Ejection Fraction （LVEF%） [Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.]
• Brain Natriuretic Peptide（BNP） [Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.]
• NYHA class [Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.]
• Grip strength [Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.]
• Length of hospitalization [Time frame: From hospitalization to discharge, an average of 12 weeks.]
• Short Physical Performance Battery（SPPB） [Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.]
• Activities of Daily Living（ADL） [Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.]
• Quality of life using MLHFQ scale [Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.]
• Degree of frailty. [Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.]

Eligibility criteria

Inclusion criteria

• Hospitalized for ADHF for over 24 hours.
• Age 18-80 years.
• At least one acute heart failure symptom: dyspnea at rest or exertion, fatigue, orthopnea, or paroxysmal nocturnal dyspnea.
• At least two heart failure signs: confirmed pulmonary congestion or edema on exam or chest X-ray, jugular venous distension, peripheral edema, rapid weight gain (>2 kg in 3 days), or elevated BNP (≥100 ng/L) and NT-proBNP (≥300 ng/L).
• Change in heart failure treatment plan with initiation or increased dosage of: diuretics, vasodilators, positive inotropic agents (e.g., digoxin), or other neurohormonal modulators (ACEI/ARB/ARNI, β-blocker, MRA).

Exclusion criteria

• Indications for urgent cardiovascular surgery (e.g., heart transplantation, left ventricular assist device).
• Cardiogenic shock.
• Recent deep vein thrombosis.
• Severe cardiovascular diseases (e.g., severe aortic stenosis, mitral regurgitation).
• GFR <30 ml/min or need for dialysis during the study.
• Severe COPD (FEV1/FVC <0.7 post-bronchodilator, with severe defined as 30% ≤ FEV1 <50% predicted, and very severe as FEV1 <30% predicted).
• Severe frailty (Clinical Frailty Scale CFS ≥7).
• Mental, psychological, cognitive disorders, or substance dependence.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

China · 1 center

• Peaking University First Hospital — Beijing

Publications

• Chioncel O, Mebazaa A, Maggioni AP, Harjola VP, Rosano G, Laroche C, Piepoli MF, Crespo-Leiro MG, Lainscak M, Ponikowski P, Filippatos G, Ruschitzka F, Seferovic P, Coats AJS, Lund LH; ESC-EORP-HFA Heart Failure Long-Term Registry Investigators. Acute heart failure congestion and perfusion status - impact of the clinical classification on in-hospital and long-term outcomes; insights from the ESC-E PMID 31127678
• Pack QR, Priya A, Lagu T, Pekow PS, Berry R, Atreya AR, Ades PA, Lindenauer PK. Cardiac Rehabilitation Utilization During an Acute Cardiac Hospitalization: A NATIONAL SAMPLE. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):19-26. doi: 10.1097/HCR.0000000000000374. PMID 30586111
• Patti A, Merlo L, Ambrosetti M, Sarto P. Exercise-Based Cardiac Rehabilitation Programs in Heart Failure Patients. Heart Fail Clin. 2021 Apr;17(2):263-271. doi: 10.1016/j.hfc.2021.01.007. Epub 2021 Feb 12. PMID 33673950
• Lesyuk W, Kriza C, Kolominsky-Rabas P. Cost-of-illness studies in heart failure: a systematic review 2004-2016. BMC Cardiovasc Disord. 2018 May 2;18(1):74. doi: 10.1186/s12872-018-0815-3. PMID 29716540
• Taylor RS, Walker S, Smart NA, Piepoli MF, Warren FC, Ciani O, Whellan D, O'Connor C, Keteyian SJ, Coats A, Davos CH, Dalal HM, Dracup K, Evangelista LS, Jolly K, Myers J, Nilsson BB, Passino C, Witham MD, Yeh GY; ExTraMATCH II Collaboration. Impact of Exercise Rehabilitation on Exercise Capacity and Quality-of-Life in Heart Failure: Individual Participant Meta-Analysis. J Am Coll Cardiol. 2019 Ap PMID 30922474
• Maddocks S, Cobbing S. Patients' Experiences of and Perspectives on Phase 1 Cardiac Rehabilitation after Coronary Artery Bypass Graft Surgery. Physiother Can. 2017;69(4):333-340. doi: 10.3138/ptc.2016-39GH. PMID 30369701
• Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A PMID 35083827
• Zou CH, Zhang J. [Interpretation of 2023 ESC focused update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure]. Zhonghua Xin Xue Guan Bing Za Zhi. 2023 Dec 24;51(12):1268-1272. doi: 10.3760/cma.j.cn112148-20230908-00143. Chinese. PMID 38123211

Identifiers

NCT: NCT06795737 · Peaking UFH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗