The Efficacy of Aerobic Exercise in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury

NCT ID: NCT06404411

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-12-30

Brief Summary

A study of the efficacy of aerobic exercise based on cardiopulmonary exercise test in the rehabilitation of patients with COVID-19-related myocardial injury

Conditions

Long COVID; Myocardial Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention group

Group Type: EXPERIMENTAL

Assigned interventions

Intervention Type: OTHER

Combined aerobic endurance exercise in the control group: individualized exercise prescription, including 5-10 minutes of pre-exercise dynamic stretching and warm-up, 10-30 minutes of formal aerobic exercise, and 5-10 minutes of post-exercise stretching, formal aerobic exercise using a power bike starting from low-intensity and gradually increasing to medium-high-intensity, with a frequency of five times per week.

conventional rehabilitation

Intervention Type: OTHER

Adoption of conventional rehabilitation, drug therapy, enhanced nutritional support and other conventional treatment

control group

Group Type: ACTIVE_COMPARATOR

conventional rehabilitation

Intervention Type: OTHER

Adoption of conventional rehabilitation, drug therapy, enhanced nutritional support and other conventional treatment

Interventions

Assigned interventions

Combined aerobic endurance exercise in the control group: individualized exercise prescription, including 5-10 minutes of pre-exercise dynamic stretching and warm-up, 10-30 minutes of formal aerobic exercise, and 5-10 minutes of post-exercise stretching, formal aerobic exercise using a power bike starting from low-intensity and gradually increasing to medium-high-intensity, with a frequency of five times per week.

Intervention Type: OTHER

conventional rehabilitation

Adoption of conventional rehabilitation, drug therapy, enhanced nutritional support and other conventional treatment

Intervention Type: OTHER

Other Intervention Names

aerobic endurance exercise

Eligibility Criteria

Inclusion Criteria

1. Between the ages of 18 and 65 years;

2. A history of new coronavirus infection;

3. Patients with a clinical diagnosis of COVID-19-related myocardial injury;

4. In the late stages of recovery from COVID-19-related myocardial injury, at least 3 months after diagnosis;

5. Negative cardiopulmonary exercise test;

6. After completing respiratory rehabilitation at our hospital in the previous period;

7. Normal blood biomarker tests and essentially normal 2D-STE, normal left ventricular systolic function, no spontaneous or inducible arrhythmias on electrocardiographic monitoring, and the patient's clinical status is stable, with most of the symptoms in significant remission, and the daily still activities are intolerant or do not reach the pre-disease exercise level;

8. Classification of nyha heart function of class I or II;

9. Voluntarily sign the informed consent form;

10. Not participating in other clinical trials.

Exclusion Criteria

1. a previous history of coronary atherosclerotic heart disease and heart failure;

2. a combination of severe arrhythmia or cardiogenic shock;

3. a combination of severe hypertension, hypertrophic cardiomyopathy, valvular disease of moderate or greater severity, acute myocarditis or pericarditis;

4. a combination of any disease that severely affects limb movement, such as musculoskeletal disorders or severe hepatic or renal insufficiency

5. a combination of progressive malignant tumors, infectious diseases, bleeding disorders, autoimmune diseases, etc;

6. those who have serious mental illness and are unable to cooperate

7. those with incomplete clinical data;

8. those who have dropped out or terminated the trial by themselves.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu Sport University

OTHER

Sponsor Role: lead

Responsible Party

Ping Yang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

YIPING CHEN

Role: CONTACT

836254592@qq.com

18066337119

Other Identifiers

2024058H

Identifier Type: -

Identifier Source: org_study_id