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| Name | Class |
|---|---|
| Shanghai Municipal Science and Technology Commission | OTHER_GOV |
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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.).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The new rehabilitation group | Experimental | 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. |
|
| The traditional rehabilitation group. | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronomic breathing, exercise rehabilitation, external counterpulsation, extracorporeal shock wave. | Device | Phase I rehabilitation(Metronomic breathing,exercise rehabilitation),Phase II rehabilitation (exercise rehabilitation, external counterpulsation, extracorporeal shock) wave.) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline myocardial infarct area at 6 months | The location and extent of myocardial infarction were determined by D-SPECT. | 1 day of inclusions and 6 months after the first treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events (MACE) | cardiovascular death, non-fatal myocardial infarction, unplanned coronary revascularization, stroke, heart failure, and angina-related rehospitalization | From the date of inclusion until the date of documented adverse events with 6 months |
| Other treatment-related adverse reactions |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| liujing liu, MD, PhD | Contact | +86 18917684041 | liuweijing98@sina.com | |
| zhaoxin zhu, B.D | Contact | +86 13162999337 | zhaoxinzhu0728@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200072 | China |
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|
| bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation | Device | Phase I rehabilitation (bedside rehabilitation, breathing rehabilitation), Phase II rehabilitation (breathing, balance, flexibility, movement) |
|
| 1 day of inclusions and 6 months after the first treatment. |
| Change from baseline peak oxygen consumption at 6 months | maximum oxygen and maximum kilogram oxygen uptake accessed during Cardiopulmonary Exercise Testing (CPET) | 1 day of inclusions and 6 months after the first treatment. |
| From the date of inclusion until the date of treatment-related adverse reactions within 6 months |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D015908 | Counterpulsation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D001243 | Assisted Circulation |
| D013514 | Surgical Procedures, Operative |
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