Trials / Completed
CompletedNCT05379608
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- I.M. Sechenov First Moscow State Medical University · Academic / Other
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Aim of this prospective, interventional, single-centered, randomized study is to evaluate the efficacy and safety of intermittent hypoxic-hyperoxic training 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 (polymerase chain reaction (PCR) testing, enzyme-linked immunosorbent assay (positive result at least 1 time)) 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. Patients will be randomized via the random number table method into two groups, comparable by gender, age and comorbidity: Intermittent hypoxic-hyperoxic training (intervention group) group, 30 patients who will receive 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks. Patients in the IHHT group will inhale hypoxic gas mixtures (10-12% O2) followed by exposure to a hyperoxic gas mixture with 30-35% O2. A control group of 30 patients will undergo a simulated IHHT course with the same "exposure" time and number of sessions. Patients of this group will breathe normoxic gas mixture using the same equipment; ordinary humidified air is supplied through the mask during the entire session. Patients eligible for inclusion will undergo the following investigations: * Anamnesis and complaints collection; physical examination; * Assessment of the quality of life and psycho-emotional status using the Short Form-36 (SF36) and Hospital Anxiety and Depression Scale (HADS) questionnaires, as well as the six-minute walk test; * General and biochemical blood tests , urine analysis, , determination of markers of inflammation (ferritin, C-reactive protein, D-dimer, fibrinogen, interleukin-1, interleukin-6, interleukin-18 and tumor necrosis factor), the level of Endothelin-1 and nitric oxide (NO) in the blood; * Electrocardiography, a flow mediated dilatation procedure for endothelial function assessment,transthoracic echocardiography to identify the structural and functional features of the myocardium, spiroergometry to determine the patient's oxygen consumption. The statistical processing will be performed using the Python Software Foundation version 3.8 for Windows (Delaware, USA). 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 stages after suffering a 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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Intermittent hypoxic-hyperoxic training | 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. |
| PROCEDURE | Intermittent hypoxic-hyperoxic training/control | 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. |
Timeline
- Start date
- 2021-12-10
- Primary completion
- 2023-12-31
- Completion
- 2025-04-30
- First posted
- 2022-05-18
- Last updated
- 2025-07-11
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT05379608. Inclusion in this directory is not an endorsement.