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Acute Decompensated Heart FailureEACH-ADHFNCT06161987

EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

A study testing Early comprehensive rehabilitation in people with Acute Decompensated Heart Failure, run by Guangdong Provincial People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Decompensated Heart Failure
What is being tested?
Early comprehensive rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
1 Dec 2023to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Involved in other interventional clinical trials.
  • Patients deemed unfit for participation in this study by the researchers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Huan Ma, PhD, +8615018755932

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Early Comprehensive Rehabilitation in Patients With ADHF, A Multicenter, Randomized, Controlled Trial.

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.

Read the detailed description

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.

Being tested
Early comprehensive rehabilitation
Keywords
Acute decompensated heart failure, Early comprehensive rehabilitation, Inspiratory muscle training, Exercise training, KCCQ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early comprehensive rehabilitationBehavioural

    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).

Study groups in NCT06161987
Study groupRoleWhat they receive
Rehabilitation Intervention GroupActive comparatorComprehensive rehabilitation plan containing 18 sessions of a structured exercise and inspiratory muscle training program over 6 weeks (3 times per week).
Receives: Behavioral: Early comprehensive rehabilitation
Attention ControlNo interventionConventional care with bi-weekly contact from study personnel.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 6

  2. 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

    Measured: Baseline and Week 6

Secondary outcomes (4)
  1. 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.

    Measured: Baseline and Week 6

  2. 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.

    Measured: Baseline and Week 6

  3. Pulmonary Function

    Measurements of forced vital capacity and forced expiratory volume in 1 s were obtained with a computerized spirometer.

    Measured: Baseline and Week 6

  4. Rate of All-Cause Rehospitalization

    Number of all-cause rehospitalizations 6 months from hospital discharge.

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start1 Dec 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06161987
Sponsor's protocol ID
KY-Q-2022-487-03
Acronym
EACH-ADHF
Status last verified
Aug 2025
First submitted
19 Jul 2023
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33999544
  • 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.

    PubMed 29413370
  • 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.

    PubMed 28267466
  • 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.

    PubMed 33624071
  • 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.

    PubMed 35350537
  • 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.

    PubMed 24093859
  • 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.

    PubMed 18436118
  • 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.

    PubMed 35363499
  • 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.

    PubMed 18165909
  • 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.

    PubMed 32956621
  • 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.

    PubMed 42086268

Questions about this trial

What is this clinical trial studying?

A study testing Early comprehensive rehabilitation in people with Acute Decompensated Heart Failure, run by Guangdong Provincial People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huan Ma, PhD (+86 15078755932, mahuandoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) (time frame: Baseline and Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06161987, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.

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