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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911100
• Other study ID #: 691-??
• Status: Recruiting
• Start date: August 25, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Oksana Kamenskaya, PhD, MD
• Phone: +79139458972
• Email: o_kamenskaya[@]meshalkin.ru
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• COVID19 Infection

Intervention

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
• 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

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.

Locations

Country	Name	City	State
Russian Federation	Meshalkin Scientific Research Center of the Ministry of Health of Russia	Novosibirsk	Novosibirsk Oblast

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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