Clinical trial NCT06385834: The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction
Official title: The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Keywords: Circadian rhythm
ST-segment Elevation Myocardial Infarction
Aerobic exercise
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 201
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was divided into three groups: morning intervention group (8:00-9:00AM), evening intervention group (16:00-17:00AM) and control group
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: left ventricle ejection fraction
timeFrame: at baseline，at the sixth week, and after the 12th week of training or follow-up
Secondary outcomes:
measure: Oxygen consumption
timeFrame: at baseline，at the sixth week, and after the 12th week of training or follow-up
measure: Endothelial Function
timeFrame: at baseline，at the sixth week, and after the 12th week of training or follow-up
measure: Skeletal muscle and fat mass
timeFrame: at baseline，at the sixth week, and after the 12th week of training or follow-up
measure: Cardiac structure
timeFrame: at baseline，at the sixth week, and after the 12th week of training or follow-up
measure: One year major Adverse Cardiovascular Events
timeFrame: From baseline to one year after participating in rehabilitation
measure: VE/VCO2-SLOPE
timeFrame: at baseline，at the sixth week, and after the 12th week of training or follow-up
measure: Flow-mediated dilation
timeFrame: at baseline, at the sixth week, and after the 12th week of training or follow-up
measure: glucose
timeFrame: at baseline, at the sixth week, and after the 12th week of training or follow-up
measure: Blood lipid
timeFrame: at baseline, at the sixth week, and after the 12th week of training or follow-up
measure: N-terminal pro-BNP
timeFrame: at baseline, at the sixth week, and after the 12th week of training or follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
References: