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EACH-ADHF: Early Comprehensive Rehabilitation in patients with ADHF study is a multi-center, parallel-group, randomized controlled trial designed to evaluate the effects of the early comprehensive rehabilitation including exercise and inspiratory muscle training, over a period of 6 weeks, on the quality of life of patients with ADHF.
Guangdong Provincial People's Hospital will be the lead center, with an additional 8 hospitals designated as satellite centers for the study. To sum up, these centers will recruit a total of 140 consenting patients. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 6-week progressive, comprehensive exercise training and inspiratory muscle training or attention control.
The intervention group will receive an 6-week exercise program consisting of endurance, resistance, balance, mobility, and inspiratory muscle training. The comprehensive rehabilitation will begin during the patient's stay and continue to the outpatient clinic. The control group will receive usual care with bi-weekly contact from study personnel. The primary outcomes of the study are improvements in the summary score of KCCQ and PImax%pred, while secondary endpoints include the impact on physical function, cardiac function, psychological status, and major adverse cardiovascular events (MACE). Additionally, the study will also explore the effects of comprehensive rehabilitation on hospital readmission and mortality rates, with follow-up assessments planned up to 6 months after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation Intervention Group | Active Comparator | Comprehensive rehabilitation plan containing 18 sessions of a structured exercise and inspiratory muscle training program over 6 weeks (3 times per week). |
|
| Attention Control | No Intervention | Conventional care with bi-weekly contact from study personnel. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early comprehensive rehabilitation | Behavioral | Patients randomized to the rehabilitation intervention group will be offered comprehensive rehabilitation plan containing 18 sessions of a structured outpatient-based exercise program over 6 weeks (3 times per week). |
| Measure | Description | Time Frame |
|---|---|---|
| Score of Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. | Baseline and Week 6 |
| Maximal Inspiratory Pressure as a Percentage of Predicted Value (PImax%pred) | Participants will tries their best to exhale to the residual position, and then inhale as much as possible for 2~3 seconds to measure PImax and the percentage of PImax%pred | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Score of Short Physical Performance Battery (SPPB) | The SPPB measures physical function using 3 components: standing balance with progressively narrow base of support, usual gait speed over 4 meters, and time to complete 5 chair rises. The total score ranges from 0 to 12, with higher scores indicating better physical function. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Score of Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12) | The SF-12 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status. | Baseline and Week 6 |
| Score of Anxiety |
Inclusion Criteria:
Age between 18-80
At least one symptom of heart failure upon admission:
Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue.
At least two of the signs of heart failure (HF):
Distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure.
Pulmonary edema or pulmonary congestion (rales or chest X-ray/CT evidence of pulmonary congestion).
Peripheral edema. Elevated B-type natriuretic peptide (>100 pg/ml) or elevated NT-proBNP (>300 pg/ml).
Able to independently perform basic activities of daily living before admission.
Able to complete the baseline assessment and initiate the specified treatment.
Able to walk 4 meters at the time of enrollment (assistive devices may be used).
Agree to participate in this study, sign a written informed consent form, and is willing to cooperate with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huan Ma, PhD | Contact | +86 15078755932 | mahuandoctor@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33999544 | Background | Kitzman DW, Whellan DJ, Duncan P, Pastva AM, Mentz RJ, Reeves GR, Nelson MB, Chen H, Upadhya B, Reed SD, Espeland MA, Hewston L, O'Connor CM. Physical Rehabilitation for Older Patients Hospitalized for Heart Failure. N Engl J Med. 2021 Jul 15;385(3):203-216. doi: 10.1056/NEJMoa2026141. Epub 2021 May 16. | |
| 29413370 | Background |
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| Score of Frailty | Patients were classified as frail if they met three or more of the following criteria: weak grip strength, physical exhaustion, slowness, low physical activity and unintentional weight loss. | Baseline and Week 6 |
| Pulmonary Function | Measurements of forced vital capacity and forced expiratory volume in 1 s were obtained with a computerized spirometer. | Baseline and Week 6 |
| Rate of All-Cause Rehospitalization | Number of all-cause rehospitalizations 6 months from hospital discharge. | Month 6 |
Anxiety is assessed by General Anxiety Disorder-7. Score ranges from 0 to 21 points, with higher scores indicating more severe anxiety. |
| Baseline and Week 6 |
| Score of Depression | Depression is assessed by Patient Health Questionnaire-9. Score of Patient Health Questionnaire-9 ranges from 0 to 27 points, with higher scores indicating more severe mood depression. | Baseline and Week 6 |
| Left ventricular ejection fraction (LVEF) | Using Echocardiography to assess the left ventricular ejection fraction (LVEF) | Baseline and Week 6 |
| Left ventricular end-diastolic volume (LVEDV) | Using Echocardiography to assess the left ventricular end-diastolic volume (LVEDV) | Baseline and Week 6 |
| Left ventricular end-systolic volume (LVESV) | Using Echocardiography to assess the left ventricular end-systolic volume (LVESV) | Baseline and Week 6 |
| Rate of All-cause Rehospitalizations | Number of all-cause rehospitalizations at 3 and 6 months from hospital discharge. | Month 3, 6 |
| Rate of All-cause Composite Rehospitalization and Death | Composite number of all-cause rehospitalizations and death at 3 and 6 months from hospital discharge. | Month 3, 6 |
| The concentration of N-Terminal Pro-Brain Natriuretic Peptide (BNP/NT-proBNP) | The concentration of N-Terminal Pro-Brain Natriuretic Peptide (BNP/NT-proBNP) | Baseline and Week 6 |
| Incidence of adverse events and serious adverse events | Incidence of adverse events and serious adverse events at 3 and 6 months from hospital discharge. | Month 3, 6 |
| Incidence of Cardiovascular-related Composite Rehospitalization and Death | Composite number of cardiovascular-related rehospitalizations and death at 3 and 6 months from hospital discharge. | Month 3, 6 |
| Proteomics analysis | Two 5ml tubes of blood were drawn at baseline and at 6 weeks, and a centrifuge was used to separate serum, plasma, and blood cells for mechanistic exploration. | Baseline and Week 6 |
| Mudge AM, Denaro CP, Scott AC, Meyers D, Adsett JA, Mullins RW, Suna JM, Atherton JJ, Marwick TH, Scuffham P, O'Rourke P. Addition of Supervised Exercise Training to a Post-Hospital Disease Management Program for Patients Recently Hospitalized With Acute Heart Failure: The EJECTION-HF Randomized Phase 4 Trial. JACC Heart Fail. 2018 Feb;6(2):143-152. doi: 10.1016/j.jchf.2017.11.016. |
| 28267466 | Background | Reeves GR, Whellan DJ, Duncan P, O'Connor CM, Pastva AM, Eggebeen JD, Hewston LA, Morgan TM, Reed SD, Rejeski WJ, Mentz RJ, Rosenberg PB, Kitzman DW; REHAB-HF Trial Investigators. Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial: Design and rationale. Am Heart J. 2017 Mar;185:130-139. doi: 10.1016/j.ahj.2016.12.012. Epub 2016 Dec 28. |
| 33624071 | Background | Laoutaris ID, Piotrowicz E, Kallistratos MS, Dritsas A, Dimaki N, Miliopoulos D, Andriopoulou M, Manolis AJ, Volterrani M, Piepoli MF, Coats AJS, Adamopoulos S; ARISTOS-HF trial (Aerobic, Resistance, InSpiratory Training OutcomeS in Heart Failure) Investigators. Combined aerobic/resistance/inspiratory muscle training as the 'optimum' exercise programme for patients with chronic heart failure: ARISTOS-HF randomized clinical trial. Eur J Prev Cardiol. 2021 Dec 29;28(15):1626-1635. doi: 10.1093/eurjpc/zwaa091. |
| 35350537 | Background | Wu L, Li J, Chen L, Xue M, Zheng Y, Meng F, Jiang H, Shi Z, Zhang P, Dai C. The Efficacy and Safety of Phase I Cardiac Rehabilitation in Patients Hospitalized in Cardiac Intensive Care Unit With Acute Decompensated Heart Failure: A Study Protocol for a Randomized, Controlled, Clinical Trial. Front Cardiovasc Med. 2022 Mar 8;9:788503. doi: 10.3389/fcvm.2022.788503. eCollection 2022. |
| 24093859 | Background | McNallan SM, Chamberlain AM, Gerber Y, Singh M, Kane RL, Weston SA, Dunlay SM, Jiang R, Roger VL. Measuring frailty in heart failure: a community perspective. Am Heart J. 2013 Oct;166(4):768-74. doi: 10.1016/j.ahj.2013.07.008. Epub 2013 Sep 17. |
| 18436118 | Background | Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045. |
| 35363499 | Background | Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1. |
| 18165909 | Background | Spertus JA, Jones PG, Kim J, Globe D. Validity, reliability, and responsiveness of the Kansas City Cardiomyopathy Questionnaire in anemic heart failure patients. Qual Life Res. 2008 Mar;17(2):291-8. doi: 10.1007/s11136-007-9302-5. Epub 2007 Dec 29. |
| 32956621 | Background | Takada S, Kondo T, Yasunaga M, Watanabe S, Kinoshita H, Fukuhara S, Yamamoto Y. Early rehabilitation in older patients hospitalized with acute decompensated heart failure: A retrospective cohort study. Am Heart J. 2020 Dec;230:44-53. doi: 10.1016/j.ahj.2020.09.009. Epub 2020 Sep 19. |
| 42086268 | Derived | Xu M, Chang J, Guo L, Bai B, Wang R, Liu X, Du Q, Mao Y, Xue A, Su M, Wang Y, Lin K, Ma H. Protocol for EACH-ADHF trial: efficacy and safety of early comprehensive rehabilitation in patients with acute decompensated heart failure - a multicentre, randomised controlled trial. BMJ Open. 2026 May 5;16(5):e110196. doi: 10.1136/bmjopen-2025-110196. |