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

Long COVID Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404411
• Other study ID #: 2024058H
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Chengdu Sport University
• Contact: YIPING CHEN
• Phone: 18066337119
• Email: 836254592[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Long COVID
• Myocardial Injury
• Wounds and Injuries

Intervention

Other:
• 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.
• conventional rehabilitation
Adoption of conventional rehabilitation, drug therapy, enhanced nutritional support and other conventional treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Sport University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2peak	All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).	12 weeks
Secondary	METpeak	All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).	12 weeks
Secondary	AT	All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).	12 weeks
Secondary	VEpeak	All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).	12 weeks
Secondary	BR	All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).	12 weeks
Secondary	VO2/HRpeak	All subjects were exercised in a plank fashion, using a modified Bruce protocol, in which the speed and incline were gradually increased by one level every 3 minutes during the test until the end of the exercise to reach the subject's sub-extreme volume of exercise, so that peak metabolic equivalents (METpeak), peak oxygen uptake (peak oxygen uptake, VO2peak), anaerobic threshold ( anaerobic threshold, AT), peak minute ventilation (VEpeak), breath reserve (BR), and peak oxygen pulse (VO2/HRpeak).	12 weeks
Secondary	Six-minute walk test distance, 6MWD	Select a 30-meter-long section of the corridor and post the location of the starting and ending points. Subjects were instructed to walk back and forth through the 30-meter passageway for 6 minutes, covering the longest distance as fast as they could.	12 weeks
Secondary	SDNN	Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.	12 weeks
Secondary	SDANN	Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.	12 weeks
Secondary	RMSSD	Data were captured for each subject at baseline, after 12 weeks of exercise intervention, using an ambulatory electrocardiogram for 24 hours continuously. Each phase was worn once, for a continuous 24-hour period.	12 weeks
Secondary	physical composite scale,PCS	The SF-12v2 is a shortened version of the scale developed based on the SF-36, which is comprehensive, simple, and less time-consuming, and is used to evaluate subjects' quality of life with 12 entries and 8 dimensions: general health, somatic functioning, somatic functioning, bodily pain, vitality, social functioning, affective functioning, and mental health. The higher the score, the better the quality of life and functional status of the patient.	12 weeks
Secondary	mental health composite scale,MCS	The SF-12v2 is a shortened version of the scale developed based on the SF-36, which is comprehensive, simple, and less time-consuming, and is used to evaluate subjects' quality of life with 12 entries and 8 dimensions: general health, somatic functioning, somatic functioning, bodily pain, vitality, social functioning, affective functioning, and mental health. The higher the score, the better the quality of life and functional status of the patient.	12 weeks