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

A Study of the Efficacy of Aerobic Exercise Based on Cardiopulmonary Exercise Test in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury

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 Overview

• Status: Not yet recruiting
• Conditions: Myocardial Injury; Long COVID
• Intervention / Treatment: Other: Assigned interventions; Other: conventional rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YIPING CHEN; Phone Number: 18066337119; Email: 836254592@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Other: conventional rehabilitation; Adoption of conventional rehabilitation, drug therapy, enhanced nutritional support and other conventional treatment
Experimental: intervention group	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.; Other Names: aerobic endurance exercise; Other: conventional rehabilitation; Adoption of conventional rehabilitation, drug therapy, enhanced nutritional support and other conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Chengdu Sport University

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Wounds and Injuries; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2024058H

Drug and device information, study documents

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