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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure

NCT05540054

Copd IMT

COMPLETED NA

Effects of Core Stabilization and Inspiratory Muscle Training in Patients With COPD

NCT06510686

Copd

COMPLETED NA

Effectiveness of Personalized Breathing Exercise Device in Patients With COPD

NCT06259188

Chronic Obstructive Pulmonary Disease Inspiratory Muscle Training Expiratory Muscle Training

RECRUITING NA

Examining the Effectiveness of Single-Limb Exercise Training for COPD Patients During Exacerbation Periods

NCT07348003

Chronic Obstructive Airways Disease Exacerbated

NOT_YET_RECRUITING NA

Respiratory Muscle Strength in Patients With Idiopathic Pulmonary Fibrosis

NCT03588260

Idiopathic Pulmonary Fibrosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Inspiratory Muscle Training

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IMT/PEP Group

Patients with Group E chronic obstructive pulmonary disease (COPD) who received standardized pharmacological treatment combined with inspiratory muscle training and positive expiratory pressure (IMT/PEP) therapy. The intervention was administered using a dual-function device twice daily for 12 weeks.

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No