ST-segment Elevation Myocardial Infarction (STEMI)NCT06385834
The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction
A study testing Morning aerobic exercise and Evening aerobic exercise in people with ST-segment Elevation Myocardial Infarction (STEMI), run by RenJi Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Morning aerobic exercise and Evening aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the 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.
- Being tested
- Morning aerobic exercise, Evening aerobic exercise
- Keywords
- Circadian rhythm, ST-segment Elevation Myocardial Infarction, Aerobic exercise
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning aerobic exerciseOther
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 aerobic exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Morning rehabilitation group | Experimental | 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. Receives: Other: Morning aerobic exercise |
| Evening rehabilitation group | Experimental | 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. Receives: Other: Evening aerobic exercise |
| Control group | No intervention | Patients randomly assigned to the control group will receive standard care, regular follow-up, optimized medication, and recommendations for a healthy lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricle ejection fraction
Use cardiac ultrasound system to measure left ventricle ejection fraction
Measured: at baseline，at the sixth week, and after the 12th week of training or follow-up
Secondary outcomes (10)
Oxygen consumption
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.
Measured: at baseline，at the sixth week, and after the 12th week of training or follow-up
Endothelial Function
Use high-resolution Doppler duplex ultrasound e equipment to analysis Baseline arterial diameter (mm), peak arterial diameter (mm).
Measured: at baseline，at the sixth week, and after the 12th week of training or follow-up
Skeletal muscle and fat mass
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.
Measured: at baseline，at the sixth week, and after the 12th week of training or follow-up
Cardiac structure
Use cardiac ultrasound system to measure left ventricular end-diastolic/end-systolic internal diameter, and left ventricular anterior wall thickness.
Measured: at baseline，at the sixth week, and after the 12th week of training or follow-up
One year major Adverse Cardiovascular Events
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.
Measured: From baseline to one year after participating in rehabilitation
VE/VCO2-SLOPE
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.
Measured: at baseline，at the sixth week, and after the 12th week of training or follow-up
Flow-mediated dilation
Use high-resolution Doppler duplex ultrasound e equipment to analysis FMD (%)-formula (peak diameter-baseline diameter) / (baseline diameter) *100.
Measured: at baseline, at the sixth week, and after the 12th week of training or follow-up
glucose
A fasting venous blood sample will be obtained immediately before and after the study for measurement of glucose.
Measured: at baseline, at the sixth week, and after the 12th week of training or follow-up
Blood lipid
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.
Measured: at baseline, at the sixth week, and after the 12th week of training or follow-up
N-terminal pro-BNP
A fasting venous blood sample will be obtained immediately before and after the study for measurement of N-terminal pro-BNP.
Measured: at baseline, at the sixth week, and after the 12th week of training or follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start30 Apr 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Pu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385834
- Sponsor's protocol ID
- LY2014-041-A
- Status last verified
- Dec 2024
- First submitted
- 17 Apr 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06385834
- Acronym / sponsor ID
- LY2014-041-A
- Keywords
- Circadian rhythm, ST-segment Elevation Myocardial Infarction, Aerobic exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Morning rehabilitation group | Experimental | Other: Morning aerobic exercisePatients 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. |
| Evening rehabilitation group | Experimental | Other: Evening aerobic exercisePatients 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. |
| Control group | No intervention | –Patients randomly assigned to the control group will receive standard care, regular follow-up, optimized medication, and recommendations for a healthy lifestyle. |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning aerobic exercisePatients 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. | Other | Morning rehabilitation group |
| Evening aerobic exercisePatients 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. | Other | Evening rehabilitation group |
Primary outcome
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
10 secondary outcomes
Oxygen consumption
Time frame: 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
Skeletal muscle and fat mass
Time frame: 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
One year major Adverse Cardiovascular Events
Time frame: 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
Flow-mediated dilation
Time frame: 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
Blood lipid
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning aerobic exercise and Evening aerobic exercise in people with ST-segment Elevation Myocardial Infarction (STEMI), run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun PU, MD (13817577592, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricle ejection fraction (time frame: at baseline，at the sixth week, and after the 12th week of training or follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.