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

NCT04511182 | Unknown

• 1 other identifier: CRP2
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Ventilatory efficiency (VE/VCO2 slope) change

  Baseline, 3, 6 months

• oxygen consumption (VO2) at anaerobic threshold

  Baseline, 3, 6 months

• Oxygen uptake related to work rate（ΔVO2/ΔWR）change

  Baseline, 3, 6 months

• Peak /AT Oxygen Pulse (O2-Pulse)change

  Baseline, 3, 6 months

• Peak metabolic equivalent (MET) change

  Baseline, 3, 6 months

Study Arms (2)

exercise intervention group

EXPERIMENTAL

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

Usual care group（control）

NO INTERVENTION

Patients will receive standard medications according to national guidelines, as well as education and consultations as intervention group. However，no exercise prescription is given,

Interventions

Exercise-based cardiac rehabilitation BEHAVIORAL

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.

exercise intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi Hospital, Shanghai JiaoTong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Study Officials

• Qin Shao, M.D,Ph.D

  RenJi Hospital

  STUDY CHAIR

• Jun Ma, M.D,Ph.D

  RenJi Hospital

  STUDY DIRECTOR

Central Study Contacts

Qin Shao, M.D,Ph.D

CONTACT

86-21-68385225; shaoqindr@126.com

Jun Ma, M.D,Ph.D

CONTACT

86-21-68383164; drjunma@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 13, 2020
• Study Start: February 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: February 1, 2023
• Last Updated: February 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)