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

Early Individualized-exercise Based Cardiac Rehabilitation Program in Patients With a Recent Acute Myocardial Infarction (EARLYmyo-CRPⅡ): Study Protocol for a Randomised Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Behavioral: Exercise-based cardiac rehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qin Shao, M.D,Ph.D; Phone Number: 86-21-68385225; Email: shaoqindr@126.com
• Study Contact Backup: Name: Jun Ma, M.D,Ph.D; Phone Number: 86-21-68383164; Email: drjunma@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, Shanghai Jiaotong University, School of Medicine
      • Contact: Qin Shao, M.D,Ph.D; Phone Number: 86-21-68385225; Email: shaoqindr@126.com
      • Contact: Jun Ma, M.D,Ph.D; Phone Number: 86-21-68383164; Email: drjunma@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise intervention group; Patients will receive standard medications plus EBCR 。Education covering topics related to AMI and exercise for AMI will be implemented and any consultations on exercise prescription and disease management will be explained by a cardiac rehabilitation team consisting of cardiologists, cardiology nurses and physiotherapists.	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.
No Intervention: Usual care group（control）; Patients will receive standard medications according to national guidelines, as well as education and consultations as intervention group. However，no exercise prescription is given,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Oxygen uptake related to work rate（ΔVO2/ΔWR）change	Difference in the interval changes from baseline to 3 months and 6 months in Oeygen uptake related to work rate（ΔVO2/ΔWR）comparing experimental group with control.	Baseline, 3, 6 months
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: Qin Shao, M.D,Ph.D, RenJi Hospital; Study Director: Jun Ma, M.D,Ph.D, RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: CRP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No