State of Oxygen Metabolism, Cardiovascular and Respiratory System Reserve Capacity in Patients Who Underwent COVID-19

Active, not recruiting

• Conditions: Covid19; COVID19 Infection
• Interventions: Diagnostic Test: Spirography and assessment of pulmonary diffusion capacity; Diagnostic Test: Cardiopulmonary stress test; Diagnostic Test: Computed tomography of the chest organs; Diagnostic Test: Heart echocardiography; Other: SF-36 Quality of Life Questionnaire; Diagnostic Test: Demographic and antropometric measures; Other: Indicators characterizing the severity of the underlying disease

• Registration Number: NCT05911100
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

This clinical study will create an evidence base for rehabilitation approach, which will be used for restoration of pulmonary ventilation and gas exchange, increase of tolerance to physical load reduced in patients who underwent COVID-19.

The aim of the present clinical study is to evaluate the effectiveness of medical rehabilitation of COVID-19 patients based on the study of individual physiological parameters of oxygen metabolism and reserve capabilities of the cardiovascular and respiratory systems.

Detailed Description

After an interview about the possibility of taking part in the study, the patient is presented with an informed consent form, explaining all the questions of interest. In the case of consent to participate in the study, the patient and the researcher fill out all the necessary fields of the two copies of the informed consent and sign it. If necessary, the researcher re-explains any information about the study. One copy of the informed consent remains with the patient, and the second copy is kept by the investigator, as required by Good Clinical Practice.

Once informed consent is obtained, an Individual Registration Card (IRC) is completed for the patient enrolled in the study. Completion of the IRC also continues until completion of the second phase of rehabilitation.

Pulmonary functional tests, cardiopulmonary stress testing (CPT) are performed on day 1 or 2 of inclusion of the patient in the rehabilitation program of "Federal Research Center for Fundamental and Translational Medicine" (FRC FTM) using MasterScreen Pneumo (Jaeger, Germany) and Oxycon Pro ergospirometry systems (Jaeger, Germany), in accordance with international standards. The indexes of external respiration are brought to BTPS conditions, and gas exchange - STPD. The protocol of stress testing is chosen individually, based on the proper values in accordance with the age, sex and anthropometric data of the patient. The study is conducted up to the individual maximum, followed by a recovery period. The anaerobic threshold is determined using the V-slope method. After peak load is reached, it is gradually reduced. Observation is continued until complete recovery of hemodynamic parameters, gas exchange, in case of adverse symptoms - until their disappearance. Repeated testing is performed after the rehabilitation program, before discharge from the FTC MTF.

Thoracic MSCT is performed on day 1-2 of inclusion of a patient into the rehabilitation program of the FRC FTM to assess the lesion of the bronchopulmonary system after COVID-19.

Questionnaires describing the severity of the underlying disease (mMRC respiratory impairment scale, BODE pulmonology risk scale, SMRT-CO respiratory support need scale), and SF-36 quality of life questionnaire are completed at study inclusion and after the rehabilitation program, before discharge from the FRC FTM.

Study Timeline

• Study Start: 2020-08-25
• Study First Submitted: 2023-06-18
• Study First Submitted QC: 2023-06-18
• Study First Posted: 2023-06-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• pneumonia or acute respiratory distress syndrome caused by SARS-CoV-2
• referral for a second phase of rehabilitation
• signed informed consent of the patient to participate in the study

Exclusion Criteria

• mental and/or locomotor disorders that make it impossible to adequately perform an exercise test, cooperate with the patient, and interpret the results
• conditions and diseases requiring emergency surgical intervention and/or observation and treatment in the ICU
• patient's refusal to participate in this clinical trial at any stage of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main	Computed tomography of the chest organs	Patients 18 years of age and older who have undergone COVID-19 and who are scheduled for the second stage of rehabilitation at the Federal Research Center for Fundamental and Translational Medicine
Main	Demographic and antropometric measures	Patients 18 years of age and older who have undergone COVID-19 and who are scheduled for the second stage of rehabilitation at the Federal Research Center for Fundamental and Translational Medicine
Main	Heart echocardiography	Patients 18 years of age and older who have undergone COVID-19 and who are scheduled for the second stage of rehabilitation at the Federal Research Center for Fundamental and Translational Medicine
Main	Spirography and assessment of pulmonary diffusion capacity	Patients 18 years of age and older who have undergone COVID-19 and who are scheduled for the second stage of rehabilitation at the Federal Research Center for Fundamental and Translational Medicine
Main	SF-36 Quality of Life Questionnaire	Patients 18 years of age and older who have undergone COVID-19 and who are scheduled for the second stage of rehabilitation at the Federal Research Center for Fundamental and Translational Medicine
Main	Cardiopulmonary stress test	Patients 18 years of age and older who have undergone COVID-19 and who are scheduled for the second stage of rehabilitation at the Federal Research Center for Fundamental and Translational Medicine
Main	Indicators characterizing the severity of the underlying disease	Patients 18 years of age and older who have undergone COVID-19 and who are scheduled for the second stage of rehabilitation at the Federal Research Center for Fundamental and Translational Medicine

Primary Outcome Measures

Name	Time	Method
Need for respiratory support according to SMRT-CO criteria.	From enrollment to the end of treatment at 4 to 6 weeks	The SMART-COP Score for Pneumonia Severity predicts need for intensive respiratory or vasopressor support in community-acquired pneumonia.

Secondary Outcome Measures

Name	Time	Method
Peak oxygen consumption	From enrollment to the end of treatment at 4 to 6 weeks	Maximum oxygen consumption is the highest amount of oxygen, expressed in milliliters, that a person can consume in 1 minute.
Quality of life as measured by the SF-36 questionnaire	On enrollment, after 3 and 6 months from the end of rehabilitation program	The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life.
Diffusion capacity of the lungs	From enrollment to the end of treatment at 4 to 6 weeks	Diffusing capacity is a measure of how well oxygen and carbon dioxide are transferred (diffused) between the lungs and the blood, and can be a useful test in the diagnosis and to monitor treatment of lung diseases.

Trial Locations

Locations (1)

Meshalkin Scientific Research Center of the Ministry of Health of Russia; 🇷🇺 Novosibirsk, Novosibirsk oblast, Russian Federation