Status:
COMPLETED
Effectiveness of IMT/PEP Therapy in Group E COPD and Comparison of GOLD vs STAR Classifications
Lead Sponsor:
Bugra Kerget
Conditions:
COPD
Inspiratory Muscle Training
Eligibility:
All Genders
40-80 years
Brief Summary
Background: Inspiratory muscle training combined with positive expiratory pressure (IMT/PEP) may improve outcomes in chronic obstructive pulmonary disease (COPD), but evidence in exacerbation-prone (...
Eligibility Criteria
Inclusion
- Age ≥ 40 years
- Diagnosis of Group E COPD according to GOLD 2023 criteria
- Post-bronchodilator FEV₁/FVC \< 0.70 and FEV₁ \< 50% predicted
- mMRC score ≥ 2 or CAT score ≥ 10
- History of ≥2 exacerbations or ≥1 hospitalization in the past year
- Stable clinical condition (no exacerbation in the past 2 weeks)
- Ability and willingness to perform IMT/PEP therapy
- Provided written informed consent
Exclusion
- Acute exacerbation of COPD at time of enrollment
- Contraindications to pulmonary function testing or 6-minute walk test (e.g., recent myocardial infarction, unstable angina)
- Inability to perform inspiratory or expiratory maneuvers reliably (e.g., due to cognitive or neuromuscular disorders)
- Significant orofacial muscle weakness unresponsive to modified mouthpiece
- Participation in another interventional study within the past 3 months
- Nonadherence to COPD treatment plan
- Any condition deemed by investigators to interfere with study participation
Key Trial Info
Start Date :
June 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 4 2024
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT07001462
Start Date
June 1 2023
End Date
April 4 2024
Last Update
September 24 2025
Active Locations (1)
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1
Ataturk University
Erzurum, Yakutiye, Turkey (Türkiye), 25200