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Clinical Trials/NCT06404411
NCT06404411
Not yet recruiting
Not Applicable

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

Chengdu Sport University0 sites40 target enrollmentJune 30, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Long COVID
Sponsor
Chengdu Sport University
Enrollment
40
Primary Endpoint
VO2peak
Status
Not yet recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
June 30, 2024
End Date
December 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Chengdu Sport University
Responsible Party
Principal Investigator
Principal Investigator

Ping Yang

Clinical Professor

Chengdu Sport University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

VO2peak

Time Frame: 12 weeks

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).

Secondary Outcomes

  • METpeak(12 weeks)
  • BR(12 weeks)
  • Six-minute walk test distance, 6MWD(12 weeks)
  • SDANN(12 weeks)
  • mental health composite scale,MCS(12 weeks)
  • VEpeak(12 weeks)
  • RMSSD(12 weeks)
  • physical composite scale,PCS(12 weeks)
  • AT(12 weeks)
  • VO2/HRpeak(12 weeks)
  • SDNN(12 weeks)

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