EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF (EACH-ADHF)

December 19, 2023 updated by: Lan Guo, Guangdong Provincial People's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Guangdong Provincial People's Hospital will be the lead center, with an additional 12 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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Huan Ma, PhD
          • Phone Number: +8615018755932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18-80

  2. At least one symptom of heart failure upon admission:

    Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue.

  3. 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).

  4. Able to independently perform basic activities of daily living before admission.
  5. Able to complete the baseline assessment and initiate the specified treatment.
  6. Able to walk 4 meters at the time of enrollment (assistive devices may be used).
  7. Agree to participate in this study, sign a written informed consent form, and is willing to cooperate with follow-up.

Exclusion Criteria:

  1. Acute heart failure caused by acute myocardial infarction.
  2. Severe aortic valve stenosis.
  3. Hemodynamic instability caused by poorly controlled arrhythmias.
  4. Severe heart failure and high-degree atrioventricular block, and inadequate heart rate response to pacing during exercise.
  5. Isolated pulmonary hypertension.
  6. Poorly controlled symptomatic orthostatic hypotension.
  7. Hypertrophic obstructive cardiomyopathy.
  8. Stage 5 chronic kidney failure, defined as glomerular filtration rate <15 ml/(min·1.73m²) or requiring dialysis.
  9. 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.
  10. Awaiting a heart transplant or ventricular assist device implantation within six months, or having received a heart transplant.
  11. A history of chronic lung disease except for COPD, previous lung surgery, or diseases affecting lung function, such as scoliosis.
  12. Late-stage diseases other than heart failure.
  13. Any medical history that could potentially affect protocol compliance, such as severe mental disorders, severe cognitive impairment, substance abuse, or addiction.
  14. Severe language, psychological, or physical disabilities that prevent their participation in the program.
  15. Pregnant or lactating women, or those of childbearing potential who are unwilling or unable to use effective contraceptive measures.
  16. Involved in other interventional clinical trials.
  17. Patients deemed unfit for participation in this study by the researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rehabilitation Intervention Group
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
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).
No Intervention: Attention Control
Conventional care with bi-weekly contact from study personnel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Baseline and Week 6
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)
Time Frame: Baseline and Week 6
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of Short Physical Performance Battery (SPPB)
Time Frame: Baseline and Week 6
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
Score of Frailty
Time Frame: Baseline and Week 6
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
Time Frame: Baseline and Week 6
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
Time Frame: Month 6
Number of all-cause rehospitalizations 6 months from hospital discharge.
Month 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12)
Time Frame: Baseline and Week 6
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
Time Frame: Baseline and Week 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
Time Frame: Baseline and Week 6
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
6-minute Walk Distance
Time Frame: Baseline and Week 6
Distance walked in 6 minutes.
Baseline and Week 6
Left ventricular ejection fraction (LVEF)
Time Frame: Baseline and Week 6
Using Echocardiography to assess the left ventricular ejection fraction (LVEF)
Baseline and Week 6
Left ventricular end-diastolic volume (LVEDV)
Time Frame: Baseline and Week 6
Using Echocardiography to assess the left ventricular end-diastolic volume (LVEDV)
Baseline and Week 6
Left ventricular end-systolic volume (LVESV)
Time Frame: Baseline and Week 6
Using Echocardiography to assess the left ventricular end-systolic volume (LVESV)
Baseline and Week 6
Rate of All-cause Rehospitalizations
Time Frame: Month 3, 6
Number of all-cause rehospitalizations at 3 and 6 months from hospital discharge.
Month 3, 6
Rate of All-cause Composite Rehospitalization and Death
Time Frame: Month 3, 6
Composite number of all-cause rehospitalizations and death at 3 and 6 months from hospital discharge.
Month 3, 6
Assessment of diaphragmatic excursion
Time Frame: Baseline and Week 6
Using Ultrasound of diaphragm to assess diaphragm excursion.
Baseline and Week 6
Assessment of diaphragm thickness
Time Frame: Baseline and Week 6
Using Ultrasound of diaphragm to assess diaphragm thickness
Baseline and Week 6
The concentration of N-Terminal Pro-Brain Natriuretic Peptide （BNP/NT-proBNP）
Time Frame: Baseline and Week 6
The concentration of N-Terminal Pro-Brain Natriuretic Peptide （BNP/NT-proBNP）
Baseline and Week 6
Incidence of adverse events and serious adverse events
Time Frame: Month 3, 6
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
Time Frame: Month 3, 6
Composite number of cardiovascular-related rehospitalizations and death at 3 and 6 months from hospital discharge.
Month 3, 6
Proteomics analysis
Time Frame: Baseline and Week 6
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-Q-2022-487-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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