Tests early exercise rehabilitation in people with acute worsening heart failure
Tests an exercise rehabilitation program against usual rehabilitation in people with acute decompensated heart failure.
Plain-language title generated from the registry record
Registry title: ExCR's Effects and Safety in Vulnerable ADHF Patients
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06795737, who can take part
Where in China
- Peaking University First HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- YE Jing
- Trial code
- NCT06795737
- Record updated
- 28 January 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Hospitalized for ADHF for over 24 hours; Age 18-80 years; At least one acute heart failure symptom: dyspnea at rest or exertion, fatigue, orthopnea, or paroxysmal nocturnal dyspnea; 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); 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: Indications for urgent cardiovascular surgery (e.g., heart transplantation, left ventricular assist device); Recent deep vein thrombosis; Severe cardiovascular diseases (e.g., severe aortic stenosis, mitral regurgitation); Mental, psychological, cognitive disorders, or substance dependence; GFR <30 ml/min or need for dialysis during the study; Cardiogenic shock; Severe COPD (FEV1/FVC <0.7 post-bronchodilator, with severe defined as 30% ≤ FEV1 <50% predicted, and very severe as FEV1 <30% predicted); Severe frailty (Clinical Frailty Scale CFS ≥7).