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Enhanced External Counterpulsation for Patients With Ventilation Disorders

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 25 wordsv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07075835
Lead Sponsor I.M. Sechenov First Moscow State Medical University
Conditions
(from sponsor)		 Chronic Lung Diseases
Related terms Neovascularization, Pathologic
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov