ExCR's Effects and Safety in Vulnerable ADHF Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYE Jing
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Indications for urgent cardiovascular surgery (e.g., heart transplantation, left ventricular assist device).
Cardiogenic shock.
Recent deep vein thrombosis.
Severe cardiovascular diseases (e.g., severe aortic stenosis, mitral regurgitation).
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise rehabilitation
BehavioralThe experimental group's protocol consists of two stages: in-hospital Phase I and post-discharge self-training. For Phase I, cardiac and rehab specialists assess NYHA classification, muscle strength, and mobility to create an exercise plan, supervised by therapists and nurses. Phase II involves twice-weekly outpatient rehab for 24 sessions and weekly remote guidance with WeChat and wristbands to track vitals, totaling 12 remote sessions. Exercise prescriptions are customized based on 6MWTD outcomes, with ongoing support from rehab staff and nurses.
Conventional rehabilitation
BehavioralHealth Education: Nurses provide manuals on heart failure causes, treatment, diet, exercise (detailing frequency, intensity, duration, types, and safety), and self-monitoring to control group patients. Outpatient Follow-up: Post-discharge, heart failure patients have follow-ups at 2 weeks, 1 month, 2 months, and 3 months. A multidisciplinary team of doctors, pharmacists, and nurses handles these, with doctors for assessment, pharmacists for medication education, and nurses for self-care assessment and education.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in the 6-minute walking test distance
Assess the changes in participants' 6MWT distance at baseline and 1, 2, and 3 months post-discharge.
Time frame
From enrollment to the end of the 12-week exercise rehabilitation intervention.Secondary outcomes
1
Left Ventricular Ejection Fraction （LVEF%）
Assess the changes in participants' LVEF% at baseline and 1, 2, and 3 months post-discharge.
Time frame
From enrollment to the end of the 12-week exercise rehabilitation intervention.2
Brain Natriuretic Peptide（BNP）
Assess the changes in participants' BNP at baseline and 1, 2, and 3 months post-discharge.
Time frame
From enrollment to the end of the 12-week exercise rehabilitation intervention.3
NYHA class
Assess the changes in participants' NYHA class at baseline and 1, 2, and 3 months post-discharge.
Time frame
From enrollment to the end of the 12-week exercise rehabilitation intervention.4
Grip strength
Assess grip strength using a dynamometer（CAMRY brand electronic hand dynamometer）; participants squeeze twice with their dominant hand and record the average.
Time frame
From enrollment to the end of the 12-week exercise rehabilitation intervention.Other outcomes
1
3-month all-cause readmission rate
The 3-month all-cause readmission rate of study participants post-discharge.Assessment at 3 months post-discharge.
Time frame
From enrollment to the end of the 12-week exercise rehabilitation intervention.2
3-month all-cause mortality rate
The 3-month all-cause mortality rate of study participants post-discharge.Assessment at 3 months post-discharge.
Time frame
From enrollment to the end of the 12-week exercise rehabilitation intervention.3
Adverse events
Adverse events will be monitored and recorded throughout the study. Data will be collected on falls, injuries, musculoskeletal issues, major cardiovascular events, and any other events potentially related to study protocol implementation.
Time frame
From enrollment to the end of the 12-week exercise rehabilitation intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
YE Jing
Lead sponsor
Peking University First Hospital
Sponsor institution
Source ClinicalTrials.gov
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