Effectiveness of IMT/PEP Therapy in Group E COPD and Comparison of GOLD vs STAR Classifications
- Conditions
- COPDInspiratory Muscle Training
- Registration Number
- NCT07001462
- Lead Sponsor
- Bugra Kerget
- Brief Summary
This prospective study aims to evaluate the effects of inspiratory muscle training (IMT) combined with positive expiratory pressure (PEP) therapy on respiratory function, muscle strength, and symptom burden in patients with Group E chronic obstructive pulmonary disease (COPD). The primary objective is to compare the predictive value of the GOLD and STAR classification systems in identifying patients who respond better to IMT/PEP therapy. A total of 61 patients will receive standard COPD treatment along with IMT/PEP twice daily for 12 weeks. Pulmonary function tests, dyspnea scores, and 6-minute walk test results will be assessed at baseline, at 1 month, and at 3 months. Regression analysis will be used to determine the independent predictors of treatment response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Maximal Inspiratory Pressure (MIP) After 12 Weeks of IMT/PEP Therapy Baseline and Week 12 Maximal inspiratory pressure (MIP) was measured at baseline and after 12 weeks using a digital manometer at residual volume (RV) to evaluate the effect of IMT/PEP therapy on inspiratory muscle strength.
Change in Residual Volume (RV) After 12 Weeks of IMT/PEP Therapy Baseline and Week 12 Residual volume (RV) was obtained through whole-body plethysmography at baseline and after 12 weeks to assess the impact of IMT/PEP therapy on pulmonary hyperinflation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ataturk University
🇹🇷Erzurum, Yakutiye, Turkey