Investigation of the Acute Effects of Traditional and Functional IMT on Muscle Oxygenation in COPD

April 7, 2026 updated by: Saglik Bilimleri Universitesi

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Keçiören
      • Ankara, Keçiören, Turkey (Türkiye), 06018
        • Gulhane Faculty of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chronic Obstructive Pulmonary Disease
Other: Traditional inspiratory muscle training
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).
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 .
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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).
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
Heart rate value will be measured with a pulse oximeter.
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
Saturation values will be measured with a pulse oximeter.
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
The hemoglobin value of muscle tissue will be measured using the near infrared spectroscopy (NIRS) method.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025/489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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