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

NCT06404411 | Not Yet Recruiting

• 1 other identifier: 2024058H
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• METpeak

  12 weeks

• AT

  12 weeks

• VEpeak

  12 weeks

• BR

  12 weeks

• VO2/HRpeak

  12 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

Other: Assigned interventions; Other: conventional rehabilitation

control group

ACTIVE COMPARATOR

Other: conventional rehabilitation

Interventions

Assigned interventions 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.

Also known as: aerobic endurance exercise

intervention group

conventional rehabilitation OTHER

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

control group; intervention group

Eligibility Criteria

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

You may qualify if:

• Between the ages of 18 and 65 years;
• A history of new coronavirus infection;
• Patients with a clinical diagnosis of COVID-19-related myocardial injury;
• In the late stages of recovery from COVID-19-related myocardial injury, at least 3 months after diagnosis;
• Negative cardiopulmonary exercise test;
• After completing respiratory rehabilitation at our hospital in the previous period;
• 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;
• Classification of nyha heart function of class I or II;
• Voluntarily sign the informed consent form;
• Not participating in other clinical trials.

You may not qualify if:

• a previous history of coronary atherosclerotic heart disease and heart failure;
• a combination of severe arrhythmia or cardiogenic shock;
• a combination of severe hypertension, hypertrophic cardiomyopathy, valvular disease of moderate or greater severity, acute myocarditis or pericarditis;
• a combination of any disease that severely affects limb movement, such as musculoskeletal disorders or severe hepatic or renal insufficiency
• a combination of progressive malignant tumors, infectious diseases, bleeding disorders, autoimmune diseases, etc;
• those who have serious mental illness and are unable to cooperate
• those with incomplete clinical data;
• those who have dropped out or terminated the trial by themselves.

Sponsors & Collaborators

• Chengdu Sport University: lead

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

YIPING CHEN

CONTACT

18066337119; 836254592@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 8, 2024
• Study Start: June 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05