Effectiveness of IMT/PEP Therapy in Group E COPD and Comparison of GOLD vs STAR Classifications (NCT07001462) | Clinical Trial Compass
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 range
40 Years – 80 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Maximal Inspiratory Pressure (MIP) After 12 Weeks of IMT/PEP Therapy
Timeframe: Baseline and Week 12
2
Change in Residual Volume (RV) After 12 Weeks of IMT/PEP Therapy