NCT07001462

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: Bugra Kerget · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• Inspiratory Muscle Training

Interventions

Type	Name	Description
BEHAVIORAL	Inspiratory Muscle Training / Positive Expiratory Pressure (IMT/PEP) Therapy	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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-02-03
• Completion: 2024-04-04
• First posted: 2025-06-03
• Last updated: 2025-09-24

Locations

1 site across 1 country: Turkey (Türkiye)