EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

NCT06161987 | Recruiting

• 1 other identifier: KY-Q-2022-487-03
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Decompensated Heart Failure

Keywords

Acute decompensated heart failure; Early comprehensive rehabilitation; Inspiratory muscle training; Exercise training; KCCQ

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Score of Short Physical Performance Battery (SPPB)

  Baseline and Week 6

• Score of Frailty

  Baseline and Week 6

• Pulmonary Function

  Baseline and Week 6

• Rate of All-Cause Rehospitalization

  Month 6

Other Outcomes (12)

• Score of Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12)

  Baseline and Week 6

• Score of Anxiety

  Baseline and Week 6

• Score of Depression

  Baseline and Week 6

Study Arms (2)

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).

Behavioral: Early comprehensive rehabilitation

Attention Control

NO INTERVENTION

Conventional care with bi-weekly contact from study personnel.

Interventions

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).

Rehabilitation Intervention 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:

• 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.

You may not qualify if:

• Acute heart failure caused by acute myocardial infarction.
• Severe aortic valve stenosis.
• Hemodynamic instability caused by poorly controlled arrhythmias.
• Severe heart failure and high-degree atrioventricular block, and inadequate heart rate response to pacing during exercise.
• Isolated pulmonary hypertension.
• Poorly controlled symptomatic orthostatic hypotension.
• Hypertrophic obstructive cardiomyopathy.
• Stage 5 chronic kidney failure, defined as glomerular filtration rate \<15 ml/(min·1.73m²) or requiring dialysis.
• Undergoing screening tests with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than or equal to 5 times the upper limit of the normal range defined by the center.
• Awaiting a heart transplant or ventricular assist device implantation within six months, or having received a heart transplant.
• A history of chronic lung disease except for COPD, previous lung surgery, or diseases affecting lung function, such as scoliosis.
• Late-stage diseases other than heart failure.
• Any medical history that could potentially affect protocol compliance, such as severe mental disorders, severe cognitive impairment, substance abuse, or addiction.
• Severe language, psychological, or physical disabilities that prevent their participation in the program.
• Pregnant or lactating women, or those of childbearing potential who are unwilling or unable to use effective contraceptive measures.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 33999544 BACKGROUND

• 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.

  PMID: 29413370 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.

  PMID: 28267466 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.

  PMID: 33624071 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.

  PMID: 35350537 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.

  PMID: 24093859 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.

  PMID: 18436118 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.

  PMID: 35363499 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.

  PMID: 18165909 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.

  PMID: 32956621 BACKGROUND

Central Study Contacts

Huan Ma, PhD

CONTACT

+86 15078755932; mahuandoctor@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Cardiology, Director of the Department of Cardiac Rehabilitation

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)