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This study evaluates enhanced external counterpulsation as a non-pharmacological therapy for patients with severe and moderate ventilation disorders due to chronic lung diseases (chronic obstructive pulmonary disease, bronchial asthma and interstitial lung diseases). The study will include 80 patients with severe (30% < forced expiratory volume in 1 second < 49% or lung diffusion capacity < 40%) and moderate (50% < forced expiratory volume in 1 second < 59% or lung diffusion capacity 40-60%) ventilation disorders, who will be divided into 2 groups (the main group and the comparison group). In addition to optimal pharmacological therapy according to the current clinical guidelines of the Russian Ministry of Health, the main group will receive a course of enhanced external counterpulsation. The comparison group will receive only optimal pharmacological therapy (according to the current clinical guidelines of the Russian Ministry of Health). At the time of inclusion in the study and after 1 month, spirometry, bodyplethysmography, lung diffusion capacity, a 6-minute walk test and an assessment of quality of life according to the SF-36 questionnaire will be conducted.
Chronic lung diseases represent a significant medical and social burden, leading to reduced quality of life and high disability rates. Despite advances in pharmacotherapy, a subset of patients remains inadequately responsive to pharmacological treatments. Enhanced external counterpulsation, initially developed for cardiology, shows potential for improving pulmonary and respiratory muscle perfusion. This method based on counterpulsation by special cuffs on the legs in the phase of diastole of the heart. The operation of the enhanced external counterpulsation device is synchronized with the patient's electrocardiogram. In the phase of diastole of the heart, there is a rapid sequential inflation of air into the cuffs in the direction from the calves to the buttocks with subsequent compression of arterial vessels and retrograde direction of blood flow in the opposite direction - to the coronary vessels. The cuffs deflate before the next systole. However, its efficacy in pulmonology patients remains understudied. An open-label controlled trial involving 80 patients (n=40 main group, n=40 control group) age 35-74 years with severe (30% < forced expiratory volume in 1 second < 49% or lung diffusion capacity < 40%) and moderate (50% < forced expiratory volume in 1 second < 59% or lung diffusion capacity 40-60%) ventilation disorders, stable condition on optimal therapy (in accordance with the current clinical guidelines of the Russian Ministry of Health (extended-release beta2-agonists, extended-release m-cholinolytics, inhaled glucocorticosteroids, systemic glucocorticosteroids). The main group will receive 20 (5 days a week for 4 weeks) one-hour procedures (compression pressure 220-280 mmHg) of enhanced external counterpulsation (device: LUMENAIR EECP, Vasomedical Inc., USA, registration certificate â„–2018/6915 dated 15.03.2018) in addition to optimal pharmacological therapy. The comparison group will receive only optimal pharmacological therapy. At the time of inclusion in the study and after 1 month, spirometry (device MIR Spirolab I, bronchodilator 400 mcg of salbutamol - Salbutamol was registered on October 14, 2011, registration number: 001925), bodyplethysmography (Jager Master Screen Body), lung diffusion capacity (Jager Master Screen Body), a 6-minute walk test and an assessment of quality of life according to the SF-36 questionnaire will be conducted. Statistical data processing will be carried out using the StatTech program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main group | Experimental | patients with severe (30% < forced expiratory volume in 1 second < 49% or lung diffusion capacity < 40%) and moderate (50% < forced expiratory volume in 1 second < 59% or lung diffusion capacity 40-60%) ventilation disorders, who are on optimal basic therapy (according to current clinical guidelines) and are in a stable state of respiratory disease (1 month without exacerbation) |
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| Control group | No Intervention | patients with severe (30% < forced expiratory volume in 1 second < 49% or lung diffusion capacity < 40%) and moderate (50% < forced expiratory volume in 1 second < 59% or lung diffusion capacity 40-60%) ventilation disorders, who are on optimal basic therapy (according to current clinical guidelines) and are in a stable state of respiratory disease (1 month without exacerbation) They will receive only optimal drug therapy for respiratory diseases in accordance with the current clinical guidelines of the Russian Ministry of Health (extended-release beta2-agonists, extended-release m-cholinolytics, inhaled and systemic glucocorticosteroids as needed). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced external counterpulsation | Procedure | 20 (5 days a week for 4 weeks) one-hour procedures (compression pressure 220-280 mmHg) of enhanced external counterpulsation (device: LUMENAIR EECP, Vasomedical Inc., USA, registration certificate â„–2018/6915 dated 15.03.2018). The systolic deflation/diastolic inflation sequence of enhanced external counterpulsation leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner in coronary artery and in others organ arteries. |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic of lung volumes | For endpoint the investigators will use bodyplethysmography at the time of inclusion in the study and after 1 month | 1 month |
| Dynamic of lung diffusion capacity | For endpoint the investigators will use lung diffusion capacity at the time of inclusion in the study and after 1 month | 1 month |
| Dynamic of physical activity tolerance | For endpoint the investigators will use 6-minute walk test at the time of inclusion in the study and after 1 month | 1 month |
| Dynamic of quality of life | For endpoint the investigators will use "SF-36 Health Status Survey" questionnaire at the time of inclusion in the study and after 1 month. The higher the score, the better the quality of life. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality from all causes | The number of deaths from any cause | 3 months |
| Number of hospitalizations due to exacerbation of the underlying disease | Number of hospitalizations for the main disease (chronic obstructive pulmonary disease, bronchial asthma, and interstitial lung diseases) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pulmonology, Clinical Hospital No. 1, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University). | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Nikolaeva N.A., Lishuta A.S., Voronkova O.O. et al. The Method of Enhanced External Counterpulsation in Clinical Practice. The Russian Archives of Internal Medicine. 2024; 14(5): 339-351. DOI: 10.20514/2226-6704-2024-14-5-339-351. https://www.medarhive.ru/jour/article/view/1850 | ||
| Result | Nikolaeva, N. A. Increase in physical activity tolerance in the background of the use of enhanced external counterpulsation in adult patients with severe respiratory pathology / N. A. Nikolaeva // Modern medicine: the view of a young doctor: Materials of the I International scientific and practical conference for residents and young scientists. In 2 volumes, Kursk, May 16-17, 2023. Volume I. - Kursk: Kursk State Medical University, 2023. - P. 138-140. | ||
| Result | Nikolaeva N.A., Belenkov Yu.N., Lishuta A.S., Voronkova O.O., Rogova E.F., Buyanova O.E., Abdullaeva G.B. Enhanced external counterpulsation as a measure of non-drug treatment of patients with severe and moderate ventilation disorders. Therapy. 2023; 9(6): 8-14. Doi: https://dx.doi.org/10.18565/therapy.2023.6.8-14 |
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The investigators can't share the research materials because the local ethics committee doesn't allow it.
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| ID | Term |
|---|---|
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 months |