A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease

Tongji University

Status: Enrolling

Conditions: Ischemic Heart Disease; Cardiac Rehabilitation

Treatments: Device: Metronomic breathing, exercise rehabilitation, external counterpulsation, extracorporeal shock wave.; Device: bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06681506

Rehabilitation-ICM

Details and patient eligibility

About

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.).

Full description

This study is a prospective, randomized, controlled study, follow the principle of PICOST design, specific as follows: Participants (the list) : preliminary clinical diagnosis of coronary atherosclerotic heart disease, heart failure. Intervention (Intervention) : conventional drug therapy + new cardiac rehabilitation therapy, a new cardiac rehabilitation treatment reference guide requirements, according to the actual circumstance of patients treated with 1-3 months Intervention. Comparator(control): conventional drug therapy + traditional cardiac rehabilitation therapy. The traditional cardiac rehabilitation therapy referred to domestic and international guidelines and consensus, and used 1 week-3 months of treatment intervention according to the actual situation of patients. Outcome (the end) : the primary end point: D_SPECT examination, were followed up for 6 months to evaluate myocardial perfusion imaging is reduce ischemic area. The secondary end point: 1) the blood biochemical examination and myocardial necrosis markers, etc.; 2) the cardiopulmonary exercise testing: maximum kilograms oxygen uptake and anaerobic threshold when the maximum kilograms oxygen uptake; 3) the major adverse cardiovascular events: cardioascular death, non-fatal myocardial infarction, unplanned coronary artery reconstruction, stroke, heart failure and angina associated hospitalized again; 4) patients family rehabilitation treatment adherence

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• acute respiratory distress syndrome (ARDS);
• acute episode of COPD;
• uncontrolled pulmonary infection;
• acute heart failure; acute pulmonary embolism;
• acute myocarditis/pericarditis;
• severe arrhythmia (degree II or III atrioventricular block, atrial flutter, or atrial fibrillation);
• sternotomy, rib fracture, thoracic deformity, or other neurological diseases that may affect respiratory muscles

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

The new rehabilitation group

Experimental group

Description:

Routine drug therapy + new cardiac rehabilitation therapy, a new cardiac rehabilitation treatment reference guide requirements, according to the actual circumstance of patients treated with 1-3 months intervention.

Treatment:

Device: Metronomic breathing, exercise rehabilitation, external counterpulsation, extracorporeal shock wave.

The traditional rehabilitation group.

Active Comparator group

Description:

Routine drug therapy + traditional cardiac rehabilitation therapy, traditional cardiac rehabilitation treatment for reference domestic and international guidelines and consensus, according to the actual circumstance of patients treated with 1-3 months intervention.

Treatment:

Device: bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation