Covid19NCT05911100
State of Oxygen Metabolism, Cardiovascular and Respiratory System Reserve Capacity in Patients Who Underwent COVID-19
An observational study of Covid19 and COVID19 Infection, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, COVID19 Infection
- What is being tested?
- Spirography and assessment of pulmonary diffusion capacity, Cardiopulmonary stress test and Computed tomography of the chest organs
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 25 Aug 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Meshalkin Scientific Research Center of the Ministry of Health of Russia
Novosibirsk, Novosibirsk Oblast, 630055
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, COVID19 Infection
- Being tested
- Spirography and assessment of pulmonary diffusion capacity, Cardiopulmonary stress test, Computed tomography of the chest organs, Heart echocardiography, SF-36 Quality of Life Questionnaire
- Keywords
- covid19, rehabilitation, oxygen metabolism
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirography and assessment of pulmonary diffusion capacityDiagnostic test
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 testDiagnostic 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 organsDiagnostic test
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 echocardiographyDiagnostic test
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 QuestionnaireOther
https://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf
Demographic and antropometric measuresDiagnostic test
Age, sex, height. weight, body mass index (BMI)
Indicators characterizing the severity of the underlying diseaseOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 to 6 weeks
Secondary outcomes (3)
Peak oxygen consumption
Maximum oxygen consumption is the highest amount of oxygen, expressed in milliliters, that a person can consume in 1 minute.
Measured: 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.
Measured: 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.
Measured: On enrollment, after 3 and 6 months from the end of rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start25 Aug 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Oksana Kamenskaya, PhD, MD, Principal investigator, Meshalkin National Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911100
- Sponsor's protocol ID
- 691-КИ
- Status last verified
- Feb 2025
- First submitted
- 18 Jun 2023
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05911100
- Acronym / sponsor ID
- 691-КИ
- Conditions
- Covid19, COVID19 Infection
- Keywords
- covid19, rehabilitation, oxygen metabolism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main | – | 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 diseasePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirography and assessment of pulmonary diffusion capacityUsing 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 | Main |
| Cardiopulmonary stress testThe 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 | Main |
| Computed tomography of the chest organsCT 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 | Main |
| Heart echocardiographyIt's a specific method of ultrasound examination, which consists in examining the heart in real time and usually does not cause any unpleasant feelings | Diagnostic test | Main |
| SF-36 Quality of Life Questionnairehttps://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf | Other | Main |
| Demographic and antropometric measuresAge, sex, height. weight, body mass index (BMI) | Diagnostic test | Main |
| 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. | Other | Main |
Primary outcome
Need for respiratory support according to SMRT-CO criteria.
Time frame: 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.
3 secondary outcomes
Peak oxygen consumption
Time frame: From enrollment to the end of treatment at 4 to 6 weeks
Diffusion capacity of the lungs
Time frame: From enrollment to the end of treatment at 4 to 6 weeks
Quality of life as measured by the SF-36 questionnaire
Time frame: On enrollment, after 3 and 6 months from the end of rehabilitation program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oksana Kamenskaya, PhD, MD principal investigator
Meshalkin National Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and COVID19 Infection, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for respiratory support according to SMRT-CO criteria. (time frame: From enrollment to the end of treatment at 4 to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.