Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation

NCT06217276 | Recruiting

• 1 other identifier: Respiratory muscle fatigue&VL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• Lower extremity muscle oxygenation level measurement

  Near Infrared Reflection Spectroscopy device will be used. The device measures and monitors muscle oxygen by taking the reflected rays of infrared rays given to the body from two different sensors to measure muscle oxygenation levels in muscle tissue. The measurement will be made in the dominant lower extremity, and the device will be placed in the mid-thigh region at the distance between the spina iliaca anterior superior reference point and the midpoint of the patella.

  20 minutes

• Lower extremity muscle total hemoglobin amount level measurement

  Near Infrared Reflection Spectroscopy device will be used. The device measures and monitors muscle total hemoglobin amount by taking the reflected rays of infrared rays given to the body from two different sensors to measure muscle oxygenation levels in muscle tissue. The measurement will be made in the dominant lower extremity, and the device will be placed in the mid-thigh region at the distance between the spina iliaca anterior superior reference point and the midpoint of the patella.

  20 minutes

Secondary Outcomes (4)

• Peripheral oxygen saturation measurement

  20 minutes

• Forced vital capacity (FVC),

  5 minutes

• Respiratory muscle strength

  10 minutes

• Forced expiratory volum in one second (FEV1)

  5 minutes

Study Arms (2)

COPD Group

ACTIVE COMPARATOR

Other: Respiratory muscle fatigue protocol

Healthy Group

ACTIVE COMPARATOR

Other: Respiratory muscle fatigue protocol

Interventions

Respiratory muscle fatigue protocol 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.

COPD Group; Healthy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ESRA PEHLİVAN

CONTACT

09050585279; fztesrakambur@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 22, 2024
• Study Start: January 20, 2024
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

TU (1)