Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT07075835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhanced External Counterpulsation for Patients With Ventilation Disorders
Sponsor:
I.M. Sechenov First Moscow State Medical University
Organization:
Study Overview
Official Title:
Enhanced External Counterpulsation as a Non-pharmacological Treatment for Patients With Severe and Moderate Ventilation Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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 №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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: