The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction
- Conditions
- ST-segment Elevation Myocardial Infarction (STEMI)
- Interventions
- Other: Evening aerobic exerciseOther: Morning aerobic exercise
- Registration Number
- NCT06385834
- Lead Sponsor
- RenJi Hospital
- Brief Summary
The aim of the study was to intervene in the Aerobic exercise time of patients with STEMI and to explore the optimal exercise time for STEMI patients
- Detailed Description
Cardiovascular disease (CVD) remains the first cause of mortality worldwide. More than 30% of CVD-connected fatalities are ascribed to ST-segment Elevation myocardial infarction (STEMI). There is strong and consistent evidence that aerobic exercise after a STEMI improves overall and cardiovascular-related mortality. Aerobic exercise (AE) acts in key mechanisms of cardiac remodeling and function improvement after STEMI, thus contributing both to prevent or postpone harmful adaptations, and even to recover from negative alterations caused by cardiac ischemia. However, the time of day to exercise for STEMI patients' optimal cardiac benefits is currently unknown.
The circadian clock endows the host with temporal precision and robust adaptation to the surrounding environment. Almost all physiologic, metabolic and endocrine processes, including glycolysis, lipid and carbohydrate metabolism as well as cardiovascular function (heart rate, blood pressure) are influenced by the circadian clock. Recent investigations in rodents utilizing gain-of-function/loss-of-function models and in humans have identified Adverse cardiovascular events have day/night patterns is related to endogenous circadian clock control of platelet activation events. Several studies have also demonstrated the effect of AE at different times on blood pressure. Indeed, timing is critical in amplifying the beneficial impact of AE. However, these studies did not address cardiac structural remodeling or other CVD-related metabolic markers, it difficult to determine the physiological and structural effects of different time AE on cardiovascular health.
Thus, In this trial our aim is to assess, in patients who have had an STEMI, AE in which time of a day can give the best benefits to cardiac remodeling and function improvement.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 201
- Between 18 and 75-years-old;
- Typical symptoms of acute myocardial infarction within 24 hours, with ST segment elevation of ≥1mm in two consecutive leads on electrocardiogram
- After receiving complete revascularization treatment
- Cardiac function grading I to II without any other serious complications
- Left ventricular ejection fraction >30%
- Compliant with the guidelines of the American College of Cardiology/American Heart Association for participating in cardiac rehabilitation standards
- Signed written informed consent.
- Patients with unstable angina
- severe symptomatic congestive heart failure detectable myocardial ischemia
- valvular disease requiring surgery
- severe ventricular arrhythmias
- severe concomitant life-threatening diseases such as cancer, and rheumatoid disease
- osteoarticular diseases that may affect the exercise process
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Evening rehabilitation group Evening aerobic exercise Patients were randomly assigned to an Evening rehabilitation group(16:00-17:00PM) for a 12-week outpatient training program that included a combination of warm-up, aerobic, and relaxation exercises three times a week. Morning rehabilitation group Morning aerobic exercise Patients were randomly assigned to the morning rehabilitation group（8:00-9:00AM） for a 12-week outpatient training program that included a combination of warm-up, aerobic, and relaxation exercises three times a week.
- Primary Outcome Measures
Name Time Method left ventricle ejection fraction at baseline，at the sixth week, and after the 12th week of training or follow-up Use cardiac ultrasound system to measure left ventricle ejection fraction
- Secondary Outcome Measures
Name Time Method Endothelial Function at baseline，at the sixth week, and after the 12th week of training or follow-up Use high-resolution Doppler duplex ultrasound e equipment to analysis Baseline arterial diameter (mm), peak arterial diameter (mm).
Skeletal muscle and fat mass at baseline，at the sixth week, and after the 12th week of training or follow-up Determined by multifrequency BIA using an InBody 770 analyzer (InBody Co., Ltd), that estimate skeletal muscle mass, Body fat mass, distribution of lean body mass and ratio of segmental lean mass.
Oxygen consumption at baseline，at the sixth week, and after the 12th week of training or follow-up Patients will be submitted to cardiopulmonary exercise testing on a bicycle, using the modified Bruce protocol. Expired gases will be continuously collected throughout exercise and analyzed for ventilatory volume (VE) and for oxygen (O2) and carbon dioxide (CO2) content, using dedicated analyzers. The investigators will assess exercise capacity mainly by measuring anaerobic threshold oxygen consumption and peak oxygen consumption.
Cardiac structure at baseline，at the sixth week, and after the 12th week of training or follow-up Use cardiac ultrasound system to measure left ventricular end-diastolic/end-systolic internal diameter, and left ventricular anterior wall thickness.
glucose at baseline, at the sixth week, and after the 12th week of training or follow-up A fasting venous blood sample will be obtained immediately before and after the study for measurement of glucose.
One year major Adverse Cardiovascular Events From baseline to one year after participating in rehabilitation All patients were followed to major adverse cardiovascular events occurred. The investigators observed the incidence of major adverse cardiovascular events during follow-up, including recurrent myocardial infarction, new heart failure, intractable angina and cardiac death.
VE/VCO2-SLOPE at baseline，at the sixth week, and after the 12th week of training or follow-up Patients will be submitted to cardiopulmonary exercise testing on a bicycle, using the modified Bruce protocol. Expired gases will be continuously collected throughout exercise and analyzed for ventilatory volume (VE) and for oxygen (O2) and carbon dioxide (CO2) content, using dedicated analyzers. The VE/VCO2-SLOPE will be collected.
Flow-mediated dilation at baseline, at the sixth week, and after the 12th week of training or follow-up Use high-resolution Doppler duplex ultrasound e equipment to analysis FMD (%)-formula (peak diameter-baseline diameter) / (baseline diameter) \*100.
N-terminal pro-BNP at baseline, at the sixth week, and after the 12th week of training or follow-up A fasting venous blood sample will be obtained immediately before and after the study for measurement of N-terminal pro-BNP.
Blood lipid at baseline, at the sixth week, and after the 12th week of training or follow-up A fasting venous blood sample will be obtained immediately before and after the study for measurement of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides.
Trial Locations
- Locations (1)
Renji Hospital
🇨🇳Shanghai, China