- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267923
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- 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
-
-
Keçiören
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Chronic Obstructive Pulmonary Disease
|
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) 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
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
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
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)
November 11, 2025
Primary Completion (Actual)
January 1, 2026
Study Completion (Actual)
February 15, 2026
Study Registration Dates
First Submitted
November 17, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 7, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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