Chronic Obstructive Pulmonary Disease (COPD)NCT07267923
Investigation of the Acute Effects of Traditional and Functional IMT on Muscle Oxygenation in COPD
A study testing Traditional inspiratory muscle training and Functional inspiratory muscle training (IMT) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effects of functional and conventional inspiratory muscle training (IMT) on post-exercise muscle deoxygenation in individuals with Chronic Obstructive Pulmonary Disease (COPD). Participants will complete both training modalities on separate days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Traditional inspiratory muscle training and Functional inspiratory muscle training (IMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2025to 15 Feb 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older,
- Having a diagnosis of COPD,
- Being in stage II-III according to the GOLD classification,
- Being able to mobilize independently.
Who cannot join
- Having a recent exacerbation or complication requiring hospitalization,
- Having had a respiratory tract infection within the past month,
- Having any disease or medical condition that prevents participation in exercise, -Having cognitive impairment (a score of <24 on the Mini-Mental Test).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Faculty of Physiotherapy and Rehabilitation
Ankara, Keçiören, 06018
About this study
Official title: Investigation of the Acute Effects of Traditional and Functional Inspiratory Muscle Training on Muscle Oxygenation in Chronic Obstructive Pulmonary Disease
This study aims to compare the effects of functional and conventional inspiratory muscle training (IMT) on post-exercise muscle deoxygenation in individuals with Chronic Obstructive Pulmonary Disease (COPD). Participants will complete both training modalities on separate days. A 2-minute walk test (2MWT) will be performed baseline, and after each session. Muscle oxygenation (SmO₂) will be assessed using near-infrared spectroscopy . Dyspnea and fatigue will be evaluated with the Modified Borg Scale, and heart rate and oxygen saturation (SpO₂) will be measured by pulse oximetry. Measurements will be recorded before, after training and at the end of the walking test.
- Being tested
- Traditional inspiratory muscle training, Functional inspiratory muscle training (IMT)
- Keywords
- Chronic Obstructive Pulmonary Disease, inspiratory muscle training, functional inspiratory muscle training
- 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.
Traditional inspiratory muscle trainingOther
Traditional inspiratory muscle training is a form of training performed using a resistive breathing device that provides resistance to the muscles involved in inspiration. Inspiratory muscle training will be performed using a portable pressure-threshold device (POWERbreathe Classic IMT - Light Resistance). IMT will be administered in a seated position with upper extremities supported and the upper chest/shoulders relaxed. The training procedure will be explained to each participant and performed for 15 minutes at 40% of the maximal inspiratory pressure (MIP).
Functional inspiratory muscle training (IMT)Other
Functional inspiratory muscle training (IMT) is defined as inspiratory muscle training performed while maintaining core stabilization and postural control. Functional IMT consists of a warm-up period, core exercises, dynamic trunk activation combined with upper extremity movements, postural control exercises, and a cool-down period. The participant performs these exercises simultaneously with inspiratory muscle training.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Experimental | Not described Receives: Other: Traditional inspiratory muscle training; Other: Functional inspiratory muscle training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle oxygenation levels (SmO₂)
Muscle oxygenation (SmO₂) will be assessed using near-infrared spectroscopy .
Measured: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
Secondary outcomes (5)
Fatigue
Fatigue will be assessed before and after the walking test using the Borg scale. The scale is scored from 0 to 10, with 0 being no fatigue and 10 being extreme fatigue.
Measured: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
Dyspnea
Dyspnea severity will be assessed using the Modified Borg Scale. It consists of ten items that describe the severity of dyspnea according to degree. The scale is scored from 0 (no shortness of breath) to 10 (very severe).
Measured: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
Heart rate
Heart rate value will be measured with a pulse oximeter.
Measured: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
Saturation (SPO2)
Saturation values will be measured with a pulse oximeter.
Measured: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
hemoglobin
The hemoglobin value of muscle tissue will be measured using the near infrared spectroscopy (NIRS) method.
Measured: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start11 Nov 2025
- Primary completion1 Jan 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a crossover design with a single participant group, in which all participants receive both exercise interventions. Each participant will undergo one baseline assessment prior to any intervention. On separate days, participants will complete two different inspiratory muscle training (IMT) interventions: conventional IMT and functional IMT. A standardized outcome assessment is performed immediately after each intervention session, resulting in a total of three measurement time points (pre-intervention, post-conventional IMT, and post-functional IMT). Outcomes obtained at these three time points will be compared to determine the acute effects and relative impact of each training modality.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267923
- Sponsor's protocol ID
- 2025/489
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Effects of Traditional and Functional Inspiratory Muscle Training on Muscle Oxygenation in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07267923
- Acronym / sponsor ID
- 2025/489
- Keywords
- Chronic Obstructive Pulmonary Disease, inspiratory muscle training, functional inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 5 Dec 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.
This study aims to compare the effects of functional and conventional inspiratory muscle training (IMT) on post-exercise muscle deoxygenation in individuals with Chronic Obstructive Pulmonary Disease (COPD). Participants will complete both training modalities on separate days. A 2-minute walk test (2MWT) will be performed baseline, and after each session. Muscle oxygenation (SmO₂) will be assessed using near-infrared spectroscopy . Dyspnea and fatigue will be evaluated with the Modified Borg Scale, and heart rate and oxygen saturation (SpO₂) will be measured by pulse oximetry. Measurements will be recorded before, after training and at the end of the walking test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a crossover design with a single participant group, in which all participants receive both exercise interventions. Each participant will undergo one baseline assessment prior to any intervention. On separate days, participants will complete two different inspiratory muscle training (IMT) interventions: conventional IMT and functional IMT. A standardized outcome assessment is performed immediately after each intervention session, resulting in a total of three measurement time points (pre-intervention, post-conventional IMT, and post-functional IMT). Outcomes obtained at these three time points will be compared to determine the acute effects and relative impact of each training modality.
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Experimental | Other: Traditional inspiratory muscle training, Other: Functional inspiratory muscle training (IMT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years of age or older,
- Having a diagnosis of COPD,
- Being in stage II-III according to the GOLD classification,
- Being able to mobilize independently.
Key exclusion criteria (3 listed)
- Having a recent exacerbation or complication requiring hospitalization,
- Having had a respiratory tract infection within the past month,
- Having any disease or medical condition that prevents participation in exercise, -Having cognitive impairment (a score of <24 on the Mini-Mental Test).
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 |
|---|---|---|
| Traditional inspiratory muscle trainingTraditional inspiratory muscle training is a form of training performed using a resistive breathing device that provides resistance to the muscles involved in inspiration. Inspiratory muscle training will be performed using a portable pressure-threshold device (POWERbreathe Classic IMT - Light Resistance). IMT will be administered in a seated position with upper extremities supported and the upper chest/shoulders relaxed. The training procedure will be explained to each participant and performed for 15 minutes at 40% of the maximal inspiratory pressure (MIP). | Other | Chronic Obstructive Pulmonary Disease |
| Functional inspiratory muscle training (IMT)Functional inspiratory muscle training (IMT) is defined as inspiratory muscle training performed while maintaining core stabilization and postural control. Functional IMT consists of a warm-up period, core exercises, dynamic trunk activation combined with upper extremity movements, postural control exercises, and a cool-down period. The participant performs these exercises simultaneously with inspiratory muscle training. | Other | Chronic Obstructive Pulmonary Disease |
Primary outcome
Muscle oxygenation levels (SmO₂)
Time frame: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
Muscle oxygenation (SmO₂) will be assessed using near-infrared spectroscopy .
5 secondary outcomes
Fatigue
Time frame: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
Dyspnea
Time frame: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
Heart rate
Time frame: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
Saturation (SPO2)
Time frame: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
hemoglobin
Time frame: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT
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 9 Apr 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Traditional inspiratory muscle training and Functional inspiratory muscle training (IMT) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Saglik Bilimleri Universitesi 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 4 inclusion and 3 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 9 Apr 2026. 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?
Muscle oxygenation levels (SmO₂) (time frame: 1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.