The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction
1 other identifier
interventional
201
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2024
CompletedFirst Posted
Study publicly available on registry
April 26, 2024
CompletedStudy Start
First participant enrolled
April 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2028
December 31, 2024
December 1, 2024
4 years
April 17, 2024
December 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
left ventricle ejection fraction
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 Outcomes (10)
Oxygen consumption
at baseline，at the sixth week, and after the 12th week of training or follow-up
Endothelial Function
at baseline，at the sixth week, and after the 12th week of training or follow-up
Skeletal muscle and fat mass
at baseline，at the sixth week, and after the 12th week of training or follow-up
Cardiac structure
at baseline，at the sixth week, and after the 12th week of training or follow-up
One year major Adverse Cardiovascular Events
From baseline to one year after participating in rehabilitation
- +5 more secondary outcomes
Study Arms (3)
Morning rehabilitation group
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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 INTERVENTIONPatients randomly assigned to the control group will receive standard care, regular follow-up, optimized medication, and recommendations for a healthy lifestyle.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Renji Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
April 17, 2024
First Posted
April 26, 2024
Study Start
April 30, 2024
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
July 30, 2028
Last Updated
December 31, 2024
Record last verified: 2024-12