Intermittent Hypoxic-hyperoxic Training in Patients With Cardiovascular Pathology After COVID-19 Infection.

NCT05379608 | Completed

• 1 other identifier: AB -1771
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this prospective, interventional, single-center, randomized study is to evaluate the efficacy and safety of intermittent hypoxic-hyperoxic training (IHHT) as a rehabilitation method in patients with cardiovascular pathology in the early period after coronavirus infection. The study will include 60 patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University. The patients will be divided into 2 groups (intervention and control groups). Intervention group will inhale hypoxic gas mixtures (10-12% O2) followed by exposure to a hyperoxic gas mixture with 30-35% O2 5 times a week for 3 weeks, while control group will undergo a simulated IHHT. All the patients will undergo identical laboratory and instrumental testing before IHHT, after the last IHHT procedure, in a month after the last IHHT procedure and in 6 months. Estimated result of the study is to confirm or refute the hypothesis of the study that a three-week course of IHHT in patients with cardiovascular pathology in the early period after coronavirus infection can improve exercise tolerance, as well as the quality of life and psychoemotional status, and affect the dynamics of laboratory and instrumental parameters.

Conditions

COVID-19; Chronic Heart Failure; Hypertension; Arrhythmia; Conduct Disorder; Chronic Coronary Syndrome; Endothelial Dysfunction; Diastolic Dysfunction; Oxygen Consumption; Quality of Life; Exercise Tolerance

Keywords

COVID-19; inflammation; intermittent hypoxic-hyperoxic training; markers of inflammation; flow mediated dilatation

Outcome Measures

Primary Outcomes (3)

• Change in the levels of proinflammatory cytokines.

  This outcome will be assessed by taking blood samples from a peripheral vein before and after IHHT to determine and compare the levels of proinflammatory cytokines such as Interleukin-1, Interleukin-6, Interleukin-18 and Tumor necrosis factor.

  In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.

• Change of the endothelial function

  This outcome will be assessed via taking blood samples from a peripheral vein before and after IHHT to determine and compare the levels of endothelin-1 and nitric oxide. Measurement of endothelial function will be done by using Flow Mediated Dilation (FMD). The technique involves ultrasound measurement of arterial dilation in response to a 5-minute occlusion of the brachial artery with a blood pressure cuff.

  In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.

• Changes in indicators of diastolic dysfunction.

  This outcome will be assessed via transthoracic echocardiography (EchoCG). Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler. Diastolic function of the left ventricle will be assessed using pulse-wave, constant-wave, and tissue Doppler studies. Received data will be compared to the initial one before the IHHT sessions started and the conclusion about diastolic dysfunction will be made.

  In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.

Secondary Outcomes (6)

• Change in exercise tolerance after intermittent hypoxic-hyperoxic training.

  In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.

• Change in maximum level of oxygen consumption after intermittent hypoxic-hyperoxic training.

  In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.

• Change in the levels of ferritin.

  In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.

• Change in the levels of C-reactive protein.

  In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.

• Change in the levels of D-dimer.

  In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.

Study Arms (2)

intervention group

EXPERIMENTAL

The patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University will be included in the study.

Procedure: Intermittent hypoxic-hyperoxic training

control group

PLACEBO COMPARATOR

The patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University will be included in the study.

Procedure: Intermittent hypoxic-hyperoxic training/control

Interventions

Intermittent hypoxic-hyperoxic training PROCEDURE

IHHT will be carried out using the ReOxy normobaric hypoxic therapy apparatus (Bitmos GmbH, Germany, 26790/10221, 04/10/2019). Each patient will undergo a hypoxic test to assess the individual response to hypoxia. The minimum safe SpO2 value is 82%, and the maximum allowable heart rate increase during exercise is + 50% of the starting value. When these parameters are reached, an automatic switch to the supply of a hyperoxic gas mixture (35-40% oxygen) occurs till the SpO2 level is 100%. During each training session a hypoxic gas mixture is supplied to the patient in an intermittent mode, alternating with the supply of a hyperoxic gas mixture. On average, each workout includes 6 of the above cycles. The total time of inhalation of a hypoxic gas mixture during one procedure is 20-30 minutes.

intervention group

Intermittent hypoxic-hyperoxic training/control PROCEDURE

IHHT will be carried out using the ReOxy normobaric hypoxic therapy apparatus (Bitmos GmbH, Germany, 26790/10221, 04/10/2019). A control group of 30 patients will undergo a simulated IHHT course (with the same "exposure" time and number of sessions as intervention group - 15 sessions, 40-minutes long each, 5 workouts per week for 3 weeks). Patients of this group will breathe normoxic gas mixture (ordinary humidified air is supplied through the mask) during the entire session.

control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent to participate in the study;
• Age 40 and over;
• Male and female;
• One or more cardiovascular pathologies in the anamnesis:
• a reliably confirmed diagnosis of hypertension, stage I-III (the diagnosis was made in accordance with the National Clinical Guidelines - 2019);
• stable angina pectoris I-III functional class, confirmed by complaints, anamnesis and physical examination and with the help of diagnostic tests (bicycle ergometry or daily electrocardiography monitoring);
• confirmed diagnosis of arrhythmias and conduction disorders based on electrocardiography data and 24-hour Holter monitoring (premature depolarization, supraventricular tachycardia, atrial fibrillation, sick sinus syndrome, atrioventricular block I-II, bundle branch blocks);
• chronic heart failure stage I-IIB, I-III functional class (New York Heart Association Functional Classification), confirmed by the presence of clinical signs and at least one of two criteria: myocardial dysfunction of left ventricle or / and an increase in the level of the N-terminal fragment of brain natriuretic peptide over 125 pg / ml;
• the presence of signs of systolic or diastolic dysfunction of the left ventricle according to echocardiography.
• COVID-19 infection confirmed by laboratory tests (polymerase chain reaction testing, enzyme-linked immunosorbent assay (positive result at least 1 time) with a CT degree of 3 or higher.
• Acute infectious diseases, tuberculosis;
• Chronic somatic diseases in the acute stage;
• Congenital anomalies of the heart and large vessels;
• Valvular heart defects (congenital and acquired);
• Severe atherosclerosis of the lower extremities'vessels (chronic ischemia of the lower extremities,stage 3-4);

You may not qualify if:

• Refusal to further participation in the study;
• Acute psychotic reactions arising in the process of the study;
• Exacerbation of chronic diseases, requiring a change in patient management tactics and preventing his or her further participation in the study.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University (Institute for personalized cardiology, Center "Digital biodesign and personalized healthcare").

Moscow, 119435, Russia

Location

MeSH Terms

Conditions

COVID-19; Hypertension; Arrhythmias, Cardiac; Conduct Disorder; Inflammation

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; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Philipp Kopylov

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: participant and the specialists who will carry out investigations (blood and urine analysis, electrocardiography, a flow mediated dilatation procedure, transthoracic echocardiography).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 18, 2022
• Study Start: December 10, 2021
• Primary Completion: December 31, 2023
• Study Completion: April 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)