Enhanced External Counterpulsation for Patients With Ventilation Disorders

NCT07075835 | Active Not Recruiting

• 1 other identifier: 154247
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Lung Diseases

Keywords

enhanced external counterpulsation; ventilation disorders; chronic lung diseases; microcirculation; neoangiogenesis; physical activity tolerance

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• Mortality from all causes

  3 months

• Number of hospitalizations due to exacerbation of the underlying disease

  1 months

Study Arms (2)

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)

Procedure: Enhanced external counterpulsation

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).

Interventions

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 №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.

Main group

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Verified 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 in patients with different chronic lung diseases who are on optimal basic therapy (according to current clinical guidelines) and are in a stable state of respiratory disease (1 month without exacerbations)
• Signed informed voluntary consent to participate in the study

You may not qualify if:

• A history of thrombophlebitis and/or phlebitis
• Thoracic or abdominal aortic aneurysm
• Severe pathology of the valvular heart (Area of orifice in stenoses: Aortic and tricuspid valves: \< 1.0 cm²; Mitral valve: \< 1.5 cm². Pulmonary valve: pressure gradient between right ventricle and pulmonary artery \> 50 mmHg; In case of insufficiency, regurgitation of grade 3-4 according to echocardiography)
• Pregnancy
• High pulmonary hypertension (grade 2-3; \>45 mmHg)
• Catheterization cardiac arrest performed within 2-4 weeks before the study
• Tachyarrhythmias (device Myocard-12)
• Uncontrolled arterial hypertension (\>180/110 mmHg when treated with 3 drugs, one of which is a diuretic)
• Hemorrhagic conditions critical arterial ischemia of the lower extremities (Stages 3 and 4 of chronic arterial insufficiency of the lower extremities according to the Pokrovsky-Fontaine classification are patients with pain at rest and with trophic or infectious-inflammatory changes in the tissues of the extremities
• Dilatation of the heart cavities (device Philips iU22 Ultrasound)
• Ejection fraction \<50% (device Philips iU22 Ultrasound)
• Level of NT-pro BNP \> 125 pg/ml
• A history of myocardial infarction
• Severe renal (glomerular filtration rate \<30 ml/min/1,73 m2) failure
• Hepatic failure (B and C on the Child-Pugh scale)

Sponsors & Collaborators

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

Study Sites (1)

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

Location

Related Publications (3)

• 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

  BACKGROUND

• 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

  RESULT

MeSH Terms

Conditions

Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)