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NCT05379608Completed

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

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

Source: ClinicalTrials.gov · Last updated 11 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
43 (actual)
First submitted
30 Apr 2022
Start date
10 Dec 2021
Primary completion date
31 Dec 2023
Lead sponsor
I.M. Sechenov First Moscow State Medical University
NCT number
NCT05379608

What you commit to

  • Study type: Interventional
  • Participants enrolled: 43
  • From 10 Dec 2021 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Exacerbation of chronic diseases, requiring a change in patient management tactics and preventing his or her further participation in the study.

Other

  • Refusal to further participation in the study;
  • Acute psychotic reactions arising in the process of the study;

Who the study is looking for

  • 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.
    • Non-inclusion criteria:
  • 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);
  • Acute decompensated heart failure (II-IV class according to Killip classification);
  • Chronic heart failure IV functional class (New York Heart Association Functional Classification classification);
  • Secondary arterial hypertension;
  • Acute coronary syndrome within 4 weeks before the start of the study;
  • Life-threatening rhythm and conduction disturbances;
  • Bronchial asthma with the development of respiratory failure II-III degree;
  • Acute cerebrovascular accident within the last 4 months;
  • Chronic kidney disease (glomerular filtration rate\<30 ml / min / 1.73 m2 via CKD-EPI (chronic kidney disease epidemiology collaboration) formula);
  • Pregnancy;
  • Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive psychosis);
  • Oncology, diagnosed within a year or receiving a course of radiation / chemotherapy for cancer at the present time;
  • Severe cognitive impairment (MOS) and clinically significant anxiety and / or depression (HADS) interfering with observation;
  • Individual intolerance to oxygen deficiency.

Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University (Institute for personalized cardiology, Center "Digital biodesign and personalized healthcare").
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.