Clinical trial NCT06404411: The Efficacy of Aerobic Exercise in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury
Official title: A Study of the Efficacy of Aerobic Exercise Based on Cardiopulmonary Exercise Test in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long COVID
Myocardial Injury
Lead sponsor: Chengdu Sport University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: VO2peak
timeFrame: 12 weeks
Secondary outcomes:
measure: METpeak
timeFrame: 12 weeks
measure: AT
timeFrame: 12 weeks
measure: VEpeak
timeFrame: 12 weeks
measure: BR
timeFrame: 12 weeks
measure: VO2/HRpeak
timeFrame: 12 weeks
measure: Six-minute walk test distance, 6MWD
timeFrame: 12 weeks
measure: SDNN
timeFrame: 12 weeks
measure: SDANN
timeFrame: 12 weeks
measure: RMSSD
timeFrame: 12 weeks
measure: physical composite scale，PCS
timeFrame: 12 weeks
measure: mental health composite scale，MCS
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: