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

NCT05911100 | Active Not Recruiting

• 1 other identifier: 691-КИ
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; COVID19 Infection

Keywords

covid19; rehabilitation; oxygen metabolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Peak oxygen consumption

  From enrollment to the end of treatment at 4 to 6 weeks

• Diffusion capacity of the lungs

  From enrollment to the end of treatment at 4 to 6 weeks

• Quality of life as measured by the SF-36 questionnaire

  On enrollment, after 3 and 6 months from the end of rehabilitation program

Study Arms (1)

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

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

Interventions

Spirography and assessment of pulmonary diffusion capacity DIAGNOSTIC_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

Main

Cardiopulmonary stress test DIAGNOSTIC_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.

Main

Computed tomography of the chest organs DIAGNOSTIC_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.

Main

Heart echocardiography DIAGNOSTIC_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

Main

SF-36 Quality of Life Questionnaire OTHER

https://clinmedjournals.org/articles/jmdt/jmdt-2-023-figure-1.pdf

Main

Demographic and antropometric measures DIAGNOSTIC_TEST

Age, sex, height. weight, body mass index (BMI)

Main

Indicators characterizing the severity of the underlying disease OTHER

* 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.

Main

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Meshalkin Scientific Research Center of the Ministry of Health of Russia

Novosibirsk, Novosibirsk Oblast, 630055, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Oksana Kamenskaya, PhD, MD

  Meshalkin National Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 20, 2023
• Study Start: August 25, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

RU (1)