CompletedNot Applicable

Effectiveness of IMT/PEP Therapy in Group E COPD and Comparison of GOLD vs STAR Classifications

Turkey (Türkiye)61 participantsStarted 2023-06-01

Plain-language 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 (Group E) disease is limited. This study is designed to evaluate the effects of IMT/PEP on pulmonary function, respiratory muscle strength, exercise capacity, and dyspnea in stable Group E COPD. Methods : This prospective randomized controlled trial will enroll 62 patients with stable Group E COPD between June 2023 and September 2024. Participants will be randomized to receive IMT/PEP plus standard care or standard care alone. Pulmonary function tests, maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), six-minute walk test (6MWT), oxygen saturation (SO₂), and dyspnea scales (mMRC, CAT, MBS, VAS) will be assessed at baseline, 1 month, and 3 months.

Who can participate

Age range40 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Criteria: 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

What they're measuring

Change in Maximal Inspiratory Pressure (MIP) After 12 Weeks of IMT/PEP Therapy

Timeframe: Baseline and Week 12

Change in Residual Volume (RV) After 12 Weeks of IMT/PEP Therapy

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT07001462

SponsorBugra Kerget

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-03