Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
Location status: Recruiting
NCT Number: NCT06681506
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.).
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200072, China
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Phase I rehabilitation(Metronomic breathing,exercise rehabilitation),Phase II rehabilitation (exercise rehabilitation, external counterpulsation, extracorporeal shock) wave.)
Phase I rehabilitation (bedside rehabilitation, breathing rehabilitation), Phase II rehabilitation (breathing, balance, flexibility, movement)
Time frame: 1 day of inclusions and 6 months after the first treatment.
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.
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.
maximum oxygen and maximum kilogram oxygen uptake accessed during Cardiopulmonary Exercise Testing (CPET)
Time frame: From the date of inclusion until the date of documented adverse events with 6 months
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 treatment-related adverse reactions within 6 months
Contact information is provided by the study sponsor or research team.
liujing liu, MD, PhD
CONTACT
zhaoxin zhu, B.D
CONTACT
Shanghai 10th People's Hospital
Other
A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease: a Prospective, Randomized Controlled Clinical Study
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