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

NCT07001462 | Completed

• 2 other identifiers: B.30.2ATA.0.01.00/487BAP-13001 (Atatürk University)
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COPD; inspiratory muscle training; pulmonary rehabilitation; GOLD; STAR

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline and Week 12

• Change in Residual Volume (RV) After 12 Weeks of IMT/PEP Therapy

  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.

  Baseline and Week 12

Study Arms (1)

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.

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

Interventions

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.

IMT/PEP Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bugra Kerget: lead

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asc.Prof.Dr.

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 3, 2025
• Study Start: June 1, 2023
• Primary Completion: February 3, 2024
• Study Completion: April 4, 2024
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

TU (1)