ExCR's Effects and Safety in Vulnerable ADHF Patients

NCT06795737 | Not Yet Recruiting

• 1 other identifier: Peaking UFH
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Decompensated Heart Failure (ADHF)

Keywords

Acute Decompensated Heart Failure (ADHF)；Vulnerable Phase；Exercise Rehabilitation；RCT

Outcome Measures

Primary Outcomes (1)

• Change in the 6-minute walking test distance

  Assess the changes in participants' 6MWT distance at baseline and 1, 2, and 3 months post-discharge.

  From enrollment to the end of the 12-week exercise rehabilitation intervention.

Secondary Outcomes (9)

• Left Ventricular Ejection Fraction （LVEF%）

  From enrollment to the end of the 12-week exercise rehabilitation intervention.

• Brain Natriuretic Peptide（BNP）

  From enrollment to the end of the 12-week exercise rehabilitation intervention.

• NYHA class

  From enrollment to the end of the 12-week exercise rehabilitation intervention.

• Grip strength

  From enrollment to the end of the 12-week exercise rehabilitation intervention.

• Length of hospitalization

  From hospitalization to discharge, an average of 12 weeks.

Other Outcomes (3)

• 3-month all-cause readmission rate

  From enrollment to the end of the 12-week exercise rehabilitation intervention.

• 3-month all-cause mortality rate

  From enrollment to the end of the 12-week exercise rehabilitation intervention.

• Adverse events

  From enrollment to the end of the 12-week exercise rehabilitation intervention.

Study Arms (2)

Experimental group

EXPERIMENTAL

Exercise rehabilitation

Behavioral: Exercise rehabilitation

Control group

SHAM COMPARATOR

Conventional rehabilitation

Behavioral: Conventional rehabilitation

Interventions

Exercise rehabilitation BEHAVIORAL

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 outcomes, with ongoing support from rehab staff and nurses.

Experimental group

Conventional rehabilitation BEHAVIORAL

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 assessment and education.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• YE Jing: lead

Study Sites (1)

Peaking University First Hospital

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (9)

• 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-EORP-HFA Heart Failure Long-Term Registry. Eur J Heart Fail. 2019 Nov;21(11):1338-1352. doi: 10.1002/ejhf.1492. Epub 2019 May 24.

  PMID: 31127678 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Apr 2;73(12):1430-1443. doi: 10.1016/j.jacc.2018.12.072.

  PMID: 30922474 BACKGROUND

• 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 BACKGROUND

• 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; ESC Scientific Document Group. 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). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.

  PMID: 35083827 BACKGROUND

• 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 BACKGROUND

• Ye J, Zhao L, Jiang Y, Hu L, Yang L, Wang Y, Ding W, Zheng Y. 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. BMJ Open. 2025 Sep 21;15(9):e102812. doi: 10.1136/bmjopen-2025-102812.

  PMID: 40976670 DERIVED

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jing Ye, MSN.

  Peaking University First Hospital

  STUDY CHAIR

• Yimeng Jiang, Ph.D.

  Peaking University First Hospital

  STUDY DIRECTOR

• Lihua Zhao, MSN.

  Peaking University First Hospital

  PRINCIPAL INVESTIGATOR

• Wenhui Ding, Prof.

  Peaking University First Hospital

  PRINCIPAL INVESTIGATOR

• Xiaoning Han, Ph.D.

  Peaking University First Hospital

  PRINCIPAL INVESTIGATOR

• Lei Yang

  Peaking University First Hospital

  PRINCIPAL INVESTIGATOR

• Yuling Wang

  Peaking University First Hospital

  PRINCIPAL INVESTIGATOR

• Baiyu Zhang

  Peaking University First Hospital

  PRINCIPAL INVESTIGATOR

• Zhuo Zhao

  Peaking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Ye, MSN.

CONTACT

+86-13051163358; 274601918@qq.com

Lihua Zhao, MSN.

CONTACT

+86-18310775771; zhaolihua0601@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Nurse of the Cardiovascular Intensive Care Unit

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 28, 2025
• Study Start: February 17, 2025
• Primary Completion: February 17, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 28, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)