This clinical study will create an evidence base for rehabilitation approach, which willbe used for restoration of pulmonary ventilation and gas exchange, increase of toleranceto physical load reduced in patients who underwent COVID-19.The aim of the present clinical study is to evaluate the effectiveness of medicalrehabilitation of COVID-19 patients based on the study of individual physiologicalparameters of oxygen metabolism and reserve capabilities of the cardiovascular andrespiratory systems.
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.
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.
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.
Meshalkin Scientific Research Center of the Ministry of Health of Russia
Novosibirsk, Novosibirsk oblast, Russian Federation
Oksana Kamenskaya, PhD, MD, Principal Investigator
Meshalkin National Research Center