Clinical trial NCT07001462: Effectiveness of IMT/PEP Therapy in Group E COPD and Comparison of GOLD vs STAR Classifications
Official title: Comparison of GOLD and STAR Classification Systems in Predicting Physiological Response to IMT/PEP Therapy in COPD: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Inspiratory Muscle Training
Keywords: COPD
inspiratory muscle training
pulmonary rehabilitation
GOLD
STAR
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 61
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 40 years and older diagnosed with Group E chronic obstructive pulmonary disease (COPD) according to GOLD 2024 criteria, with moderate to very severe airflow limitation, increased symptom burden, and a history of frequent exacerbations or hospitalizations.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Maximal Inspiratory Pressure (MIP) After 12 Weeks of IMT/PEP Therapy
timeFrame: Baseline and Week 12
measure: Change in Residual Volume (RV) After 12 Weeks of IMT/PEP Therapy
timeFrame: Baseline and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Yakutiye
Study officials:
References: