The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction

December 27, 2024 updated by: Jun Pu, RenJi Hospital
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Renji Hospital
        • Contact:
          • jUN PU, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Morning rehabilitation group
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.
Other: Morning aerobic exercise
Patients were randomly assigned to morning aerobic exercise training for a 12-week outpatient training program that included a combination of warm-up, aerobic, and relaxation exercises three times a week. Each class consists of 10 minutes of warm-up training, 40 minutes of aerobic training and 10 minutes of relaxation training. The intensity of aerobic exercise training will be personalized. According to the guidance of relevant guidelines, the exercise intensity of patients will be determined according to the results of their first cardiopulmonary exercise experiment, and the exercise load will be gradually increased according to the exercise program until the predetermined goal is reached. Patient fatigue levels will be monitored throughout the exercise using the borg scale.
Experimental: Evening rehabilitation group
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.
Other: Evening aerobic exercise
Patients were randomly assigned to evening aerobic exercise training for a 12-week outpatient training program that included a combination of warm-up, aerobic, and relaxation exercises three times a week. Each class consists of 10 minutes of warm-up training, 40 minutes of aerobic training and 10 minutes of relaxation training. The intensity of aerobic exercise training will be personalized. According to the guidance of relevant guidelines, the exercise intensity of patients will be determined according to the results of their first cardiopulmonary exercise experiment, and the exercise load will be gradually increased according to the exercise program until the predetermined goal is reached. Patient fatigue levels will be monitored throughout the exercise using the borg scale.
No Intervention: Control group
Patients randomly assigned to the control group will receive standard care, regular follow-up, optimized medication, and recommendations for a healthy lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
left ventricle ejection fraction
Time Frame: 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
at baseline，at the sixth week, and after the 12th week of training or follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen consumption
Time Frame: 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.
at baseline，at the sixth week, and after the 12th week of training or follow-up
Endothelial Function
Time Frame: 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).
at baseline，at the sixth week, and after the 12th week of training or follow-up
Skeletal muscle and fat mass
Time Frame: 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.
at baseline，at the sixth week, and after the 12th week of training or follow-up
Cardiac structure
Time Frame: 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.
at baseline，at the sixth week, and after the 12th week of training or follow-up
One year major Adverse Cardiovascular Events
Time Frame: 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.
From baseline to one year after participating in rehabilitation
VE/VCO2-SLOPE
Time Frame: 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.
at baseline，at the sixth week, and after the 12th week of training or follow-up
Flow-mediated dilation
Time Frame: 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.
at baseline, at the sixth week, and after the 12th week of training or follow-up
glucose
Time Frame: 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.
at baseline, at the sixth week, and after the 12th week of training or follow-up
Blood lipid
Time Frame: 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.
at baseline, at the sixth week, and after the 12th week of training or follow-up
N-terminal pro-BNP
Time Frame: 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.
at baseline, at the sixth week, and after the 12th week of training or follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

July 30, 2028

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 27, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2014-041-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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