COPDNCT07001462
Effectiveness of IMT/PEP Therapy in Group E COPD and Comparison of GOLD vs STAR Classifications
An observational study of COPD and Inspiratory Muscle Training, run by Bugra Kerget at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Inspiratory Muscle Training
- What is being tested?
- Inspiratory Muscle Training / Positive Expiratory Pressure (IMT/PEP) Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 4 Apr 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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
- Being tested
- Inspiratory Muscle Training / Positive Expiratory Pressure (IMT/PEP) Therapy
- Keywords
- COPD, inspiratory muscle training, pulmonary rehabilitation, GOLD, STAR
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training / Positive Expiratory Pressure (IMT/PEP) TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Inspiratory Muscle Training / Positive Expiratory Pressure (IMT/PEP) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Jun 2023
- Primary completion3 Feb 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Bugra Kerget
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bugra Kerget, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001462
- Sponsor's protocol ID
- B.30.2ATA.0.01.00/487
- Other IDs
- BAP-13001 (Atatürk University)
- Status last verified
- Sep 2025
- First submitted
- 24 May 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not been finalized. Data sharing may be considered upon reasonable request, pending ethical approval and institutional data protection policies.
Publications
Jalal L, Aksakal A, Kerget B, Ucar EY, Araz O, Saglam L, Akgun M. 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. BMC Pulm Med. 2026 Mar 6;26(1):195. doi: 10.1186/s12890-025-04078-x.
PubMed 41792683
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07001462
- Acronym / sponsor ID
- B.30.2ATA.0.01.00/487
- Conditions
- COPD, Inspiratory Muscle Training
- Keywords
- COPD, inspiratory muscle training, pulmonary rehabilitation, GOLD, STAR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bugra KergetUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 3 Feb 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMT/PEP Group | – | Behavioral: Inspiratory Muscle Training / Positive Expiratory Pressure (IMT/PEP) TherapyPatients 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Training / Positive Expiratory Pressure (IMT/PEP) TherapyIMT/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. | Behavioural | IMT/PEP Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Derived from this study: PubMed 41792683Jalal L, Aksakal A, Kerget B, Ucar EY, Araz O, Saglam L, Akgun M. 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. BMC Pulm Med. 2026 Mar 6;26(1):195. doi: 10.1186/s12890-025-04078-x.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not been finalized. Data sharing may be considered upon reasonable request, pending ethical approval and institutional data protection policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Inspiratory Muscle Training, run by Bugra Kerget at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximal Inspiratory Pressure (MIP) After 12 Weeks of IMT/PEP Therapy (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.