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

NCT ID: NCT06681506

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2031-12-31

Brief Summary

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.).

Detailed 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

Conditions

Ischemic Heart Disease; Cardiac Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The new rehabilitation group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Phase I rehabilitation(Metronomic breathing，exercise rehabilitation）,Phase II rehabilitation (exercise rehabilitation, external counterpulsation, extracorporeal shock) wave.)

The traditional rehabilitation group.

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.

Group Type: ACTIVE_COMPARATOR

bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation

Intervention Type: DEVICE

Phase I rehabilitation (bedside rehabilitation, breathing rehabilitation), Phase II rehabilitation (breathing, balance, flexibility, movement)

Interventions

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

Phase I rehabilitation(Metronomic breathing，exercise rehabilitation）,Phase II rehabilitation (exercise rehabilitation, external counterpulsation, extracorporeal shock) wave.)

Intervention Type: DEVICE

bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation

Phase I rehabilitation (bedside rehabilitation, breathing rehabilitation), Phase II rehabilitation (breathing, balance, flexibility, movement)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Municipal Science and Technology Commission

OTHER_GOV

Sponsor Role: collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

liujing liu, MD, PhD

Role: CONTACT

liuweijing98@sina.com

+86 18917684041

zhaoxin zhu, B.D

Role: CONTACT

zhaoxinzhu0728@163.com

+86 13162999337

Facility Contacts

Weijing Liu, PhD

Role: primary

liuweijing98@sina.com

+86 189 1768 4041

Yawei Xu, MD, PhD

Role: backup

Other Identifiers

Rehabilitation-ICM

Identifier Type: -

Identifier Source: org_study_id