Clinical trial NCT04511182: Early Individualized-Exercise Based Cardiac Rehabilitation Programs in Patients With Acute Myocardial Infarction
Official title: Early Individualized-exercise Based Cardiac Rehabilitation Program in Patients With a Recent Acute Myocardial Infarction (EARLYmyo-CRPⅡ): Study Protocol for a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute myocardial infarction (AMI) is a life-threatening condition and a cause of functional disability. After reperfusion therapies and pharmacological strategies, patients suffered great pain physically and mentally. How to improve the quality of life and the prognosis in patients with AMI is a hot topic in the field of cardiac rehabilitation now. In this study, a randomized, controlled and prospective clinical trial is designed for patients with AMI to improve exercise capacity, cardiometabolic parameters, as well as quality of life by an individualized, low-cost exercise intervention we developed after evaluation by Cardiopulmonary Exercise Tests (CPET). Serial CPET are performed to prospectively measure changes in aerobic exercise capacity, and the MOS item short form health survey（SF-36）are constructed to survey life quality. What's more, echocardiography and NT-proBNP are also assessed.

Detailed description: Acute myocardial infarction (AMI) is a life-threatening condition and a cause of functional disability, although reperfusion therapies and pharmacological strategies have been developed dramatically. Percutaneous coronary intervention（PCI）can effectively improve the myocardial blood supply of patients, However, various degrees of reduced exercise tolerance, anxiety and depression symptoms, impaired social function may occur after PCI and then lead to the decline of their quality of life. Exercise-based cardiopulmonary rehabilitation, which has beneficial effects on physical fitness, quality of life, cardiovascular risk factors and clinical outcome, is an important part of secondary prevention for patients after an acute myocardial infarction. Despite the evidence of these beneficial effects, cardiac rehabilitation programs are still largely underutilized and the exact benefits are still less well known. In this study, a randomized, controlled and prospective clinical trial is designed for patients with AMI to improve exercise capacity, cardiometabolic parameters, as well as quality of life by an individualized, low-cost exercise intervention we developed after evaluation by Cardiopulmonary Exercise Tests (CPET) . Serial CPET are performed to prospectively measure changes in aerobic exercise capacity, and the MOS item short form health survey（SF-36）are constructed to survey life quality. What's more, echocardiography and NT-proBNP are also assessed.

Eligibility criteria: Inclusion criteria

1. Acute myocardial infarction (AMI) within 1 months prior to recruitment.
2. Complete revascularization.
3. Man or non- pregnant women aged from 18 to 80 years.

Exclusion criteria

1. Uncontrolled hypertension (systolic blood pressure/diastolic blood pressure \>160/100 mmHg)，or symptomatic hypotension.
2. Significant resting electrocardiogram abnormalities (left bundle branch block, non-specific intraventricular conduction delay, left ventricular hypertrophy, resting ST-segment depression), life-threatening cardiac arrhythmias.
3. Acute myocarditis, pericarditis or acute systemic illness.
4. Those who are assessed by the doctor as high-risk \[12\].
5. Pacemaker or implantable cardioverter defibrillator.
6. Any contraindication to exercise testing or exercise training or inability to complete a CPET.
7. Life-threatening diseases with limited life expectancy \<3 year.
8. Uncontrolled unstable angina pectoris.
9. Significant valvular disease (mitral stenosis, moderate to severe mitral insufficiency, aortic stenosis, or aortic insufficiency, severe mitral / aortic regurgitation).
10. Severe mental or cognitive impairment.
11. Inability to follow the procedures of the study.

Primary outcomes:
measure: Peak oxygen consumption (VO2)change
timeFrame: Baseline, 3, 6 months
Secondary outcomes:
measure: Ventilatory efficiency (VE/VCO2 slope) change
timeFrame: Baseline, 3, 6 months
measure: oxygen consumption (VO2) at anaerobic threshold
timeFrame: Baseline, 3, 6 months
measure: Oxygen uptake related to work rate（ΔVO2/ΔWR）change
timeFrame: Baseline, 3, 6 months
measure: Peak /AT Oxygen Pulse (O2-Pulse)change
timeFrame: Baseline, 3, 6 months
measure: Peak metabolic equivalent (MET) change
timeFrame: Baseline, 3, 6 months
measure: Heart rate variability
timeFrame: Baseline, 3, 6 months
measure: Body mass index（BMI）change
timeFrame: Baseline, 3, 6 months
measure: LVEF change
timeFrame: Baseline, 3, 6 months
measure: NT-proBNP(pg/ml)
timeFrame: Baseline, 3, 6 months
measure: The MOS item short form health survey(SF-36)
timeFrame: Baseline, 3, 6 months
measure: The occurrence and composite of major adverse cardiac events (MACE)
timeFrame: 3, 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital, Shanghai JiaoTong University, School of Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Qin Shao, M.D,Ph.D
role: STUDY_CHAIR
affiliation: RenJi Hospital
name: Jun Ma, M.D,Ph.D
role: STUDY_DIRECTOR
References: