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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Exercise rehabilitation |
|
| Control group | Sham Comparator | Conventional rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF%) | Assess the changes in participants' LVEF% at baseline and 1, 2, and 3 months post-discharge. | From enrollment to the end of the 12-week exercise rehabilitation intervention. |
| Brain Natriuretic Peptide(BNP) |
| Measure | Description | Time Frame |
|---|---|---|
| 3-month all-cause readmission rate | The 3-month all-cause readmission rate of study participants post-discharge.Assessment at 3 months post-discharge. | From enrollment to the end of the 12-week exercise rehabilitation intervention. |
| 3-month all-cause mortality rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Ye, MSN. | Contact | +86-13051163358 | 274601918@qq.com | |
| Lihua Zhao, MSN. | Contact | +86-18310775771 | zhaolihua0601@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Ye, MSN. | Peaking University First Hospital | Study Chair |
| Yimeng Jiang, Ph.D. | Peaking University First Hospital | Study Director |
| Lihua Zhao, MSN. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peaking University First Hospital | Beijing | Beijing Municipality | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31127678 | Background | 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. | |
| 30586111 |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| 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. |
|
Assess the changes in participants' BNP at baseline and 1, 2, and 3 months post-discharge.
| From enrollment to the end of the 12-week exercise rehabilitation intervention. |
| NYHA class | Assess the changes in participants' NYHA class at baseline and 1, 2, and 3 months post-discharge. | From enrollment to the end of the 12-week exercise rehabilitation intervention. |
| Grip strength | Assess grip strength using a dynamometer(CAMRY brand electronic hand dynamometer); participants squeeze twice with their dominant hand and record the average. | From enrollment to the end of the 12-week exercise rehabilitation intervention. |
| Length of hospitalization | Length of hospitalization will be compared between intervention and control groups at discharge. | From hospitalization to discharge, an average of 12 weeks. |
| Short Physical Performance Battery(SPPB) | SPPB : Assesses physical performance with three tests: balance, 4-meter gait speed, and repeated chair stands. Each test scores 0-4; total score 0-12. Scores: 0-6 (poor), 7-9 (moderate), 10-12 (good).The SPPB scale will assess participants' physical performance at enrollment and 1, 2, and 3 months post-discharge. | From enrollment to the end of the 12-week exercise rehabilitation intervention. |
| Activities of Daily Living(ADL) | Barthel Index: 10 items (feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, walking, stairs). Each item scored 0, 5, 10, 15; total 0-100. ≤40: severe dependence; 41-60: moderate; 61-99: mild; 100: independent. Higher scores indicate greater self-care ability.The Barthel Index will be used to assess ADL changes in participants at baseline and 1, 2, and 3 months post-discharge. | From enrollment to the end of the 12-week exercise rehabilitation intervention. |
| Quality of life using MLHFQ scale | MLHFQ scale: 21-item questionnaire assessing heart failure's impact on quality of life over the past month. Three domains: physical (8 items), emotional (5 items), and other (8 items). Each item scored 0-5 (0=none, 1=rarely, 2=occasionally, 3=sometimes, 4=often, 5=always). Total score: 0-105. Higher scores indicate worse quality of life; lower scores indicate better quality of life.The Minnesota Living with Heart Failure Questionnaire will be used to assess QoL changes in participants at baseline and 1, 2, and 3 months post-discharge. | From enrollment to the end of the 12-week exercise rehabilitation intervention. |
| Degree of frailty. | Clinical Frailty Scale: 1-9 scale (very fit, well, managing well, vulnerable, mildly frail, moderately frail, severely frail, very severely frail, terminally ill). Score ≥5 indicates frailty.The Clinical Frailty Scale will be used to assess frailty changes in participants at baseline and at 1, 2, and 3 months post-discharge. | From enrollment to the end of the 12-week exercise rehabilitation intervention. |
The 3-month all-cause mortality rate of study participants post-discharge.Assessment at 3 months post-discharge. |
| From enrollment to the end of the 12-week exercise rehabilitation intervention. |
| Adverse events | Adverse events will be monitored and recorded throughout the study. Data will be collected on falls, injuries, musculoskeletal issues, major cardiovascular events, and any other events potentially related to study protocol implementation. | From enrollment to the end of the 12-week exercise rehabilitation intervention. |
| 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 |
| 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. |
| 33673950 | 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. |
| 29716540 | 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. |
| 30922474 | 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. |
| 30369701 | 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. |
| 35083827 | 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. |
| 38123211 | 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. |
| 40976670 | Derived | 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. |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |