A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShanghai 10th People's Hospital
About this trial
Cardiac rehabilitation is an important link in cardiovascular disease. This study mainly explores the effectiveness of new cardiac rehabilitation therapy (early respiratory rehabilitation, phase I rehabilitation, exercise therapy, external counterpulsation, extracorporeal shock wave, etc.) on patients with ischemic heart disease such as coronary heart disease and heart failure, and the compliance of home rehabilitation compared with traditional cardiac rehabilitation therapy (traditional exercise rehabilitation, rehabilitation education, etc.).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 85 years old
Female subjects no pregnancy
The main admission diagnosis of ischemic heart disease (coronary heart disease, myocardial infarction, ischemic heart failure, etc.)
The need for cardiac rehabilitation treatment
Disqualifiers
acute respiratory distress syndrome (ARDS);
acute episode of COPD;
uncontrolled pulmonary infection;
acute heart failure; acute pulmonary embolism;
Trial design
Design model
Parallel
Treatments tested in this trial
Metronomic breathing, exercise rehabilitation, external counterpulsation, extracorporeal shock wave.
DevicePhase I rehabilitation(Metronomic breathing，exercise rehabilitation）,Phase II rehabilitation (exercise rehabilitation, external counterpulsation, extracorporeal shock) wave.)
bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation
DevicePhase I rehabilitation (bedside rehabilitation, breathing rehabilitation), Phase II rehabilitation (breathing, balance, flexibility, movement)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: The new rehabilitation groupExperimental treatment 1 intervention
Group B: The traditional rehabilitation group.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline myocardial infarct area at 6 months
The location and extent of myocardial infarction were determined by D-SPECT.
Time frame
1 day of inclusions and 6 months after the first treatment.Secondary outcomes
1
6 months hemodynamic changes in relative to the baseline
Noninvasive hemodynamic evaluation of hemodynamic state, such as, the larger the value of Stroke volume, Stroke volume index, Cardiac output, Cardiac output index parameters, the smaller the value of Systemic vascular resistance, Systemic vascular resistance index parameters, the better the function of the patient's heart and arterial vessels.
Time frame
1 day of inclusions and 6 months after the first treatment.2
Change from baseline peak oxygen consumption at 6 months
maximum oxygen and maximum kilogram oxygen uptake accessed during Cardiopulmonary Exercise Testing (CPET)
Time frame
1 day of inclusions and 6 months after the first treatment.Other outcomes
1
Major adverse cardiovascular events (MACE）
cardiovascular death, non-fatal myocardial infarction, unplanned coronary revascularization, stroke, heart failure, and angina-related rehospitalization
Time frame
From the date of inclusion until the date of documented adverse events with 6 months2
Other treatment-related adverse reactions
Time frame
From the date of inclusion until the date of treatment-related adverse reactions within 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai 10th People's Hospital
Lead sponsor
Shanghai Municipal Science and Technology Commission
Collaborator
Source ClinicalTrials.gov