NCT06795737Not yet recruiting
ExCR's Effects and Safety in Vulnerable ADHF Patients
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
Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 19 Dec 2024
- Start date
- 17 Feb 2025
- Primary completion date
- 17 Feb 2026
- Lead sponsor
- YE Jing
- Diseases
- Heart failure
- NCT number
- NCT06795737
What you commit to
- Study type: Interventional
- Planned participants: 88
- From 17 Feb 2025 to the primary completion date, 17 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- GFR \<30 ml/min or need for dialysis during the study.
Other
- 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).
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peaking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.