Clinical trial NCT05911100: State of Oxygen Metabolism, Cardiovascular and Respiratory System Reserve Capacity in Patients Who Underwent COVID-19
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
COVID19 Infection
Keywords: covid19
rehabilitation
oxygen metabolism
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2023-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Need for respiratory support according to SMRT-CO criteria.
timeFrame: From enrollment to the end of treatment at 4 to 6 weeks
Secondary outcomes:
measure: Peak oxygen consumption
timeFrame: From enrollment to the end of treatment at 4 to 6 weeks
measure: Diffusion capacity of the lungs
timeFrame: From enrollment to the end of treatment at 4 to 6 weeks
measure: Quality of life as measured by the SF-36 questionnaire
timeFrame: On enrollment, after 3 and 6 months from the end of rehabilitation program
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Meshalkin Scientific Research Center of the Ministry of Health of Russia
state: Novosibirsk oblast
Study officials:
affiliation: Meshalkin National Research Center
name: Oksana Kamenskaya, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: