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

Evaluation of the Effectiveness of Medical Rehabilitation of COVID-19 Patients Based on the Study of Individual Physiological Parameters of Oxygen Metabolism and the Reserve Capabilities of the Cardiovascular and Respiratory Systems

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; COVID19 Infection
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Oksana Kamenskaya, PhD, MD; Phone Number: +79139458972; Email: o_kamenskaya@meshalkin.ru

Study Locations

• Russian Federation
  • Novosibirsk Oblast
    • Novosibirsk, Novosibirsk Oblast, Russian Federation, 630055
      • Recruiting
      • Meshalkin Scientific Research Center of the Ministry of Health of Russia
      • Contact: Oksana Kamenskaya, PhD, MD; Phone Number: +79139458972; Email: o_kamenskaya@meshalkin.ru

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

People 18+ years old who have undergone COVID-19 infection and are scheduled for the second stage of rehabilitation at the Federal Research Center for Fundamental and Translational Medicine.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Main; 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

Diagnostic test: Spirography and assessment of pulmonary diffusion capacity; Using the Master Screen Body device you will be asked to take two series of breaths through a special tube for 2-3 minutes. Usually the procedure does not cause any discomfort; Diagnostic test: Cardiopulmonary stress test; The exercise test is performed on a bicycle ergometer Oxycon Pro. Prior to the test, special sensors for recording the electrocardiogram, a sensor to determine blood saturation, and a cuff to measure blood pressure will be glued on the body. Breathing during the test takes place through a face mask with a built-in gas analyzer sensor. The stress test is conducted up to an individual maximum (according to the age, sex, height and weight of the patient), followed by a recovery period. There is some temporary discomfort associated with performing physical activity. Dyspnea, leg fatigue, and dizziness may occur. Observation continues until full recovery of hemodynamic and gas exchange parameters, in case of appearance of unfavorable symptoms - until their disappearance.; Diagnostic test: Computed tomography of the chest organs; CT is a method of examination based on X-rays, but unlike conventional X-rays, it gives the most complete picture of the body structure, with less radiation. Tomography usually does not cause any unpleasant feelings and is performed in a specialized department.; Diagnostic test: Heart echocardiography; It's a specific method of ultrasound examination, which consists in examining the heart in real time and usually does not cause any unpleasant feelings; Other: SF-36 Quality of Life Questionnaire; https://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf; Diagnostic test: Demographic and antropometric measures; Age, sex, height. weight, body mass index (BMI); Other: Indicators characterizing the severity of the underlying disease; Severity of underlying disease (mMRC, BODE, SMRT-CO Respiratory Support Need Scale), and comorbidities (cardiovascular disease, diabetes mellitus, chronic obstructive pulmonary disease, chronic kidney disease); Medications taken.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen consumption	Maximum oxygen consumption is the highest amount of oxygen, expressed in milliliters, that a person can consume in 1 minute.	From enrollment to the end of treatment at 4 to 6 weeks
Diffusion capacity of the lungs	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.	From enrollment to the end of treatment at 4 to 6 weeks
Quality of life as measured by the SF-36 questionnaire	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.	On enrollment, after 3 and 6 months from the end of rehabilitation program

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Investigators: Principal Investigator: Oksana Kamenskaya, PhD, MD, Meshalkin National Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: June 18, 2023
• First Posted (Actual): June 20, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; covid19; oxygen metabolism
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 691-КИ

Drug and device information, study documents

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