Early Individualized-Exercise Based Cardiac Rehabilitation Programs in Patients With Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04511182
• Other study ID #: CRP2
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: January 2021
• Source: RenJi Hospital
• Contact: Qin Shao, M.D,Ph.D
• Phone: 86-21-68385225
• Email: shaoqindr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: February 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• Exercise-based cardiac rehabilitation
Exercise program is based on aerobic exercise and supplemented by strength training following the principle of gradual improvement. The type of exercise, such as walking, jogging, cycling, and the intensity of exercise which is recommended to use a cardiotach or pedometer to detect, are both defined by the results of CPET, such as METs value. Participators must be prepared for about 5-10 minutes to warm up and recover before and after exercise. 30-50 minutes a day, 5 days a week, with a total exercise time of not less than 150 minutes per week. It can be carried out in different stages according to the physical condition. After 1-3 months, the exercise prescription will be re-adjusted according to the results of reexamination. All patients will undergo Cardiopulmonary Exercise Test, SF-36, echocardiography and laboratory examination prior to initiation of the trial, and which will be checked again after 3 months, and 6 months.

Locations

Country	Name	City	State
China	RenJi Hospital, Shanghai JiaoTong University, School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen consumption (VO2)change	Difference in the interval changes from baseline to 3 months and 6 months in peak VO2 comparing Experimental group with control.	Baseline, 3, 6 months
Secondary	Ventilatory efficiency (VE/VCO2 slope) change	Difference in the interval changes from baseline to 3 months and 6 months in Ventilatory efficiency (VE/VCO2 slope) comparing experimental group with control.	Baseline, 3, 6 months
Secondary	oxygen consumption (VO2) at anaerobic threshold	Difference in the interval changes from baseline to 3 months and 6 months in VO2 at anaerobic threshold comparing Experimental group with control.	Baseline, 3, 6 months
Secondary	Oxygen uptake related to work rate(?VO2/?WR)change	Difference in the interval changes from baseline to 3 months and 6 months in Oeygen uptake related to work rate(?VO2/?WR)comparing experimental group with control.	Baseline, 3, 6 months
Secondary	Peak /AT Oxygen Pulse (O2-Pulse)change	Difference in the interval changes from baseline to 3 months and 6 months in Peak /AT Oxygen Pulse (O2-Pulse) comparing experimental group with control.	Baseline, 3, 6 months
Secondary	Peak metabolic equivalent (MET) change	Difference in the interval changes from baseline to 3 months and 6 months in peak metabolic equivalent (MET) change comparing experimental group with control.	Baseline, 3, 6 months
Secondary	Heart rate variability	Difference in the interval changes from baseline to 3 months and 6 months in Heart rate variability comparing experimental group with control.	Baseline, 3, 6 months
Secondary	Body mass index(BMI)change	Difference in the interval changes from baseline to 3 months and 6 months in Body mass index(BMI)comparing experimental group with control. BMI is the value obtained by dividing body weight by height square (weight in kilograms, height in meters). BMI is a standard commonly used in the world to measure the degree of obesity and health of the human body.	Baseline, 3, 6 months
Secondary	LVEF change	Difference in the interval changes from baseline to 3 months and 6 months in LVEF comparing experimental group with control.	Baseline, 3, 6 months
Secondary	NT-proBNP(pg/ml)	Difference in the interval changes from baseline to 3 months and 6 months in NT-proBNP comparing Experimental group with control.	Baseline, 3, 6 months
Secondary	The MOS item short form health survey(SF-36)	Difference in the interval changes from baseline to 3 months and 6 months in The MOS item short form health survey(SF-36) comparing experimental group with control.	Baseline, 3, 6 months
Secondary	The occurrence and composite of major adverse cardiac events (MACE)	Major adverse cardiac events (MACE) included all-cause mortality, non-fatal myocardial infarction and coronary revascularisation. we check the outcome in 3 months and 6 months.	3, 6 months