EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Enrolling

Conditions: Acute Decompensated Heart Failure

Treatments: Behavioral: Early comprehensive rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06161987

KY-Q-2022-487-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Rehabilitation Intervention Group

Active Comparator group

Description:

Comprehensive rehabilitation plan containing 18 sessions of a structured exercise and inspiratory muscle training program over 6 weeks (3 times per week).

Treatment:

Behavioral: Early comprehensive rehabilitation

Attention Control

No Intervention group

Description:

Conventional care with bi-weekly contact from study personnel.