Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation

Examining the Relationship Between Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation in Chronic Obstructive Pulmonary Disease Patients.

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Other: Respiratory muscle fatigue protocol

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ESRA PEHLİVAN; Phone Number: 09050585279; Email: fztesrakambur@yahoo.com

Study Locations

• Turkey
  • Zeytinburnu
    • Istanbul, Zeytinburnu, Turkey, 34200
      • Recruiting
      • Yedikule Chest Disease Hospital
      • Contact: Esra Pehlivan; Phone Number: +902124090200; Email: fztesrakambur@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

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.

Inclusion Criteria for Healthy Cases

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: COPD Group	Other: 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.
Active Comparator: Healthy Group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral oxygen saturation measurement	During the fatigue protocol, it will be measured with a finger pulse oximeter attached to the finger	20 minutes
Forced vital capacity (FVC),	Pulmonary function test will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines. FVC is the volume of air that can forcibly be blown out after full inspiration.	5 minutes
Respiratory muscle strength	The mouth pressure measurement (maximum inspiratory and expiratory pressure) will perform with the Pony Fx spirometry device. Patient will place a rubber mouthpiece with flanges, on the device, exhale/inhale slowly and completely, and then will try to breath in as hard as possible. The patient will allow to rest for about a minute and the maneuver will repeat. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value will obtain.	10 minutes
Forced expiratory volum in one second (FEV1)	Pulmonary function test will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines. FEV1 is the volume of air that can forcibly be blown out in first 1-second, after full inspiration	5 minutes

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: Respiratory muscle fatigue&VL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No