Completed

NCT Number: NCT07001462

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Inspiratory Muscle Training Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ataturk University

Erzurum, Yakutiye, 25200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training / Positive Expiratory Pressure (IMT/PEP) Therapy

Behavioral

IMT/PEP therapy was administered using a dual-function device (BİO Breathe, Korea) designed to provide both inspiratory muscle resistance and positive expiratory pressure. Patients performed the therapy for 15 minutes, twice daily, over a 12-week period, in addition to standard pharmacological treatment. Pressure levels were individually adjusted between 5-40 cmH₂O based on patient capacity.

Primary outcomes

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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bugra Kerget

Other

Registry information

Official study title

Effects of Combined Inspiratory Muscle Training and Positive Expiratory Pressure Therapy on Pulmonary Function, Respiratory Muscle Strength, Exercise Capacity and Dyspnea in Stable Group E COPD Patients

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jun 3, 2025
Registry last updated: Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed