State of Oxygen Metabolism, Cardiovascular and Respiratory System Reserve Capacity in Patients Who Underwent COVID-19
NCT ID: NCT05911100
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2020-08-25
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
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.
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.
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
SF-36 Quality of Life Questionnaire
https://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf
Demographic and antropometric measures
Age, sex, height. weight, body mass index (BMI)
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.
Interventions
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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
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.
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.
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
SF-36 Quality of Life Questionnaire
https://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf
Demographic and antropometric measures
Age, sex, height. weight, body mass index (BMI)
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.
Eligibility Criteria
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Inclusion Criteria
* referral for a second phase of rehabilitation
* signed informed consent of the patient to participate in the study
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Principal Investigators
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Oksana Kamenskaya, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Meshalkin National Research Center
Locations
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Meshalkin Scientific Research Center of the Ministry of Health of Russia
Novosibirsk, Novosibirsk Oblast, Russia
Countries
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Other Identifiers
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691-КИ
Identifier Type: -
Identifier Source: org_study_id
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