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

NCT ID: NCT06385834

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2028-07-30

Brief Summary

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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

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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.

Conditions

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ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

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Circadian rhythm ST-segment Elevation Myocardial Infarction Aerobic exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
In this study, outcome measurement personnel and intervention personnel were separated during the whole process of the experiment, outcome measurement personnel did not know the grouping status, intervention personnel and rehabilitation therapists did not participate in the outcome measurement work.

Study Groups

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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.

Group Type EXPERIMENTAL

Morning aerobic exercise

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Evening aerobic exercise

Intervention Type OTHER

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.

Control group

Patients randomly assigned to the control group will receive standard care, regular follow-up, optimized medication, and recommendations for a healthy lifestyle.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun Pu

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renji Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun PU, MD

Role: CONTACT

Phone: 13817577592

Email: [email protected]

YiHong Du, Master

Role: CONTACT

Phone: 17717528650

Email: [email protected]

Facility Contacts

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jUN PU, PHD

Role: primary

Other Identifiers

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LY2014-041-A

Identifier Type: -

Identifier Source: org_study_id