A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Metronomic breathing, exercise rehabilitation, external counterpulsation, extracorporeal shock wave., bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation.
- Кому может быть актуально
- Состояния в реестре: Ischemic Heart Disease, Cardiac Rehabilitation. Базовые параметры: 18 лет — 85 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease: a Prospective, Randomized Controlled Clinical Study
Обзор
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.).
Подробное описание
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
Вмешательства
- Устройство 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.) - Устройство bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation
Phase I rehabilitation (bedside rehabilitation, breathing rehabilitation), Phase II rehabilitation (breathing, balance, flexibility, movement)
Первичные конечные точки
- Change from baseline myocardial infarct area at 6 months [Срок оценки: 1 day of inclusions and 6 months after the first treatment.]
Вторичные конечные точки (2)
- 6 months hemodynamic changes in relative to the baseline [Срок оценки: 1 day of inclusions and 6 months after the first treatment.]
- Change from baseline peak oxygen consumption at 6 months [Срок оценки: 1 day of inclusions and 6 months after the first treatment.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Department of Cardiology, Shanghai Tenth People's Hospital — Шанхай
Идентификаторы
NCT: NCT06681506 · Rehabilitation-ICM