Clinical trial NCT06795737: ExCR's Effects and Safety in Vulnerable ADHF Patients
Official title: Effectiveness and Safety of Exercise-based Cardiac Rehabilitation (ExCR) During the Vulnerable Period in Patients With Acute Decompensated Heart Failure (ADHF): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Decompensated Heart Failure (ADHF)
Keywords: Acute Decompensated Heart Failure (ADHF)；Vulnerable Phase；Exercise Rehabilitation；RCT
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Exercise-based cardiac rehabilitation has become a key component of the comprehensive care system for patients with stable heart failure (HF). However, due to hemodynamic instability and functional decline in early ADHF, most HF rehab studies exclude current/recent ADHF exacerbations. Currently, ADHF management strategies lack robust evidence, and the timing, duration, and frequency of exercise interventions need further validation globally.

This study aims to address the following issues:

Develop an exercise management program for ADHF patients, verify its feasibility, and determine the safety and applicability of early exercise rehabilitation; Evaluate the improvement of participants in terms of physical function, cardiac function, and quality of life.

The research team will compare the formulated exercise rehabilitation program with conventional rehabilitation guidance to verify its feasibility and effectiveness.

Participants will:

Physicians and rehabilitation therapists will comprehensively assess the participants' conditions to determine the start time of rehabilitation training. Based on the patients' cardiac function, muscle strength, and heart failure-related clinical indicators, rehabilitation training is divided into two stages (the first stage is early in-hospital training, and the second stage is self-directed training after discharge). Exercise types mainly include respiratory training, bed activities, rehabilitation pedaling, and resistance training. Rehabilitation therapists and nurses will monitor participants' vital signs during the exercise process and choose the appropriate exercise intensity based on the participants' level of fatigue.

The exercise rehabilitation program will be evaluated and adjusted every two weeks for a total period of 12 weeks.

At the time of enrollment, discharge, two weeks after discharge, and four weeks after discharge, participants will need to complete questionnaires, including demographic and disease condition surveys, grip strength tests, Activities of Daily Living (ADL) scales, Short Physical Performance Battery (SPPB) scales, Minnesota Living with Heart Failure Questionnaire (MLHFQ) scales, and 6-minute walk tests, etc.


Eligibility criteria: Inclusion Criteria:

1. Hospitalized for ADHF for over 24 hours.
2. Age 18-80 years.
3. At least one acute heart failure symptom: dyspnea at rest or exertion, fatigue, orthopnea, or paroxysmal nocturnal dyspnea.
4. At least two heart failure signs: confirmed pulmonary congestion or edema on exam or chest X-ray, jugular venous distension, peripheral edema, rapid weight gain (\>2 kg in 3 days), or elevated BNP (≥100 ng/L) and NT-proBNP (≥300 ng/L).
5. Change in heart failure treatment plan with initiation or increased dosage of: diuretics, vasodilators, positive inotropic agents (e.g., digoxin), or other neurohormonal modulators (ACEI/ARB/ARNI, β-blocker, MRA).

Exclusion Criteria:

1. Indications for urgent cardiovascular surgery (e.g., heart transplantation, left ventricular assist device).
2. Cardiogenic shock.
3. Recent deep vein thrombosis.
4. Severe cardiovascular diseases (e.g., severe aortic stenosis, mitral regurgitation).
5. GFR \<30 ml/min or need for dialysis during the study.
6. Severe COPD (FEV1/FVC \<0.7 post-bronchodilator, with severe defined as 30% ≤ FEV1 \<50% predicted, and very severe as FEV1 \<30% predicted).
7. Severe frailty (Clinical Frailty Scale CFS ≥7).
8. Mental, psychological, cognitive disorders, or substance dependence.

Primary outcomes:
measure: Change in the 6-minute walking test distance
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Secondary outcomes:
measure: Left Ventricular Ejection Fraction （LVEF%）
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
measure: Brain Natriuretic Peptide（BNP）
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
measure: NYHA class
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
measure: Grip strength
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
measure: Length of hospitalization
timeFrame: From hospitalization to discharge, an average of 12 weeks.
measure: Short Physical Performance Battery（SPPB）
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
measure: Activities of Daily Living（ADL）
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
measure: Quality of life using MLHFQ scale
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
measure: Degree of frailty.
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Other outcomes:
measure: 3-month all-cause readmission rate
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
measure: 3-month all-cause mortality rate
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
measure: Adverse events
timeFrame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Locations:
city: Beijing
country: China
facility: Peaking University First Hospital
state: Beijing
Study officials:
affiliation: Peaking University First Hospital
name: Jing Ye, MSN.
role: STUDY_CHAIR
affiliation: Peaking University First Hospital
name: Yimeng Jiang, Ph.D.
role: STUDY_DIRECTOR
affiliation: Peaking University First Hospital
name: Lihua Zhao, MSN.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peaking University First Hospital
name: Wenhui Ding, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peaking University First Hospital
name: Xiaoning Han, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peaking University First Hospital
name: Lei Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peaking University First Hospital
name: Yuling Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peaking University First Hospital
name: Baiyu Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peaking University First Hospital
name: Zhuo Zhao
role: PRINCIPAL_INVESTIGATOR
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