Chronic Lung DiseasesNCT07075835
Enhanced External Counterpulsation for Patients With Ventilation Disorders
A study testing Enhanced external counterpulsation in people with Chronic Lung Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Chronic Lung Diseases
- What is being tested?
- Enhanced external counterpulsation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2023to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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)
- Poor tolerance of the procedure (side effects that disrupt the patient's condition and prevent the continuation of procedures (local: hyperemia, pain, and itching in the area of the cuff application; systemic: hypertensive reaction, dizziness)
- Low patient compliance (skipping more than 3 procedures), refusal to participate in the study
- Exacerbation of the underlying disease during the study
Trial locations and contacts
1 site in 1 country.
Russia1 site
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
About this study
Official title: Enhanced External Counterpulsation as a Non-pharmacological Treatment for Patients With Severe and Moderate Ventilation Disorders
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.
Read the 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.
- Conditions
- Chronic Lung Diseases
- Being tested
- Enhanced external counterpulsation
- Keywords
- enhanced external counterpulsation, ventilation disorders, chronic lung diseases, microcirculation, neoangiogenesis, physical activity tolerance
- Medical subject headings
- Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced external counterpulsationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic of lung volumes
For endpoint the investigators will use bodyplethysmography at the time of inclusion in the study and after 1 month
Measured: 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
Measured: 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
Measured: 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.
Measured: 1 month
Secondary outcomes (2)
Mortality from all causes
The number of deaths from any cause
Measured: 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)
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Nov 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075835
- Sponsor's protocol ID
- 154247
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators can't share the research materials because the local ethics committee doesn't allow it.
Publications
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
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.
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced External Counterpulsation as a Non-pharmacological Treatment for Patients With Severe and Moderate Ventilation Disorders
- ClinicalTrials.gov ID
- NCT07075835
- Acronym / sponsor ID
- 154247
- Conditions
- Chronic Lung Diseases
- Keywords
- enhanced external counterpulsation, ventilation disorders, chronic lung diseases, microcirculation, neoangiogenesis, physical activity tolerance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main group | Experimental | Procedure: Enhanced external counterpulsationpatients 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) |
| 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). |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced external counterpulsation20 (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. | Procedure or surgery | Main group |
Primary outcome
Dynamic of lung volumes
Time frame: 1 month
For endpoint the investigators will use bodyplethysmography at the time of inclusion in the study and after 1 month
Dynamic of lung diffusion capacity
Time frame: 1 month
For endpoint the investigators will use lung diffusion capacity at the time of inclusion in the study and after 1 month
Dynamic of physical activity tolerance
Time frame: 1 month
For endpoint the investigators will use 6-minute walk test at the time of inclusion in the study and after 1 month
Dynamic of quality of life
Time frame: 1 month
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.
2 secondary outcomes
Mortality from all causes
Time frame: 3 months
Number of hospitalizations due to exacerbation of the underlying disease
Time frame: 1 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- BackgroundNikolaeva 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
- Results publicationNikolaeva, 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.
- Results publicationNikolaeva 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
- Individual participant dataSharing planned: No. The investigators can't share the research materials because the local ethics committee doesn't allow it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced external counterpulsation in people with Chronic Lung Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic of lung volumes (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07075835, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.