Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation

NCT ID: NCT06217276

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-20

Study Completion Date

2026-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In our study, changes in vastus lateralis muscle oxygenation will be evaluated with the Moxy device, a functional infrared oxygen measurement device, during the inspiratory muscle fatigue protocol in COPD cases and the healthy control group.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD Group

Group Type ACTIVE_COMPARATOR

Respiratory muscle fatigue protocol

Intervention Type OTHER

It will be performed using a powerbreath device at 60% of the maximum inspiratory pressure (MIP) amount obtained by measuring mouth pressure. The protocol includes 7 sets consisting of 2 minutes of inspiratory effort and 1 minute of rest. To further confirm the occurrence of fatigue, the patient will score fatigue using the modified Borg scale, and the score will be 5 or above11. During the application, heart rate, blood pressure and peripheral oxygen saturation will be monitored. The measurement will be performed once for each case.

Healthy Group

Group Type ACTIVE_COMPARATOR

Respiratory muscle fatigue protocol

Intervention Type OTHER

It will be performed using a powerbreath device at 60% of the maximum inspiratory pressure (MIP) amount obtained by measuring mouth pressure. The protocol includes 7 sets consisting of 2 minutes of inspiratory effort and 1 minute of rest. To further confirm the occurrence of fatigue, the patient will score fatigue using the modified Borg scale, and the score will be 5 or above11. During the application, heart rate, blood pressure and peripheral oxygen saturation will be monitored. The measurement will be performed once for each case.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Respiratory muscle fatigue protocol

It will be performed using a powerbreath device at 60% of the maximum inspiratory pressure (MIP) amount obtained by measuring mouth pressure. The protocol includes 7 sets consisting of 2 minutes of inspiratory effort and 1 minute of rest. To further confirm the occurrence of fatigue, the patient will score fatigue using the modified Borg scale, and the score will be 5 or above11. During the application, heart rate, blood pressure and peripheral oxygen saturation will be monitored. The measurement will be performed once for each case.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Having a diagnosis of Stage 2-3 COPD according to the following clinical diagnostic criteria according to the American Thoracic and European Respiratory Societies (ATS-ERS).
* Having been using the same medications for the last 4 weeks


* Being over 18 years of age
* Not having any diagnosed chronic disease
* Not being a smoker

Exclusion Criteria

* Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and requiring high-flow oxygen therapy (˃ 3-4 L\\min).
* Presence of any vascular problem that may affect lower extremity muscle oxygenation
* Presence of another respiratory system disease other than COPD
* Patients who have had an acute COPD exacerbation in the last 4 weeks
* Patients experiencing COPD exacerbations during the study protocol
* Presence of fatty tissue or scar tissue at the measurement points, which may impair the measurement quality.
* Have already participated in another clinical trial within the last 30 days that may affect the results of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

esra pehlivan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ESRA PEHLİVAN

Role: CONTACT

09050585279

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Esra Pehlivan

Role: primary

+902124090200

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Respiratory muscle fatigue&VL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.