Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation

Not Applicable

Recruiting

• Conditions: COPD
• Interventions: Other: Respiratory muscle fatigue protocol

• Registration Number: NCT06217276
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-30
• Study First Submitted QC: 2024-01-11
• Study Start: 2024-01-20
• Study First Posted: 2024-01-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Group	Respiratory muscle fatigue protocol	-
COPD Group	Respiratory muscle fatigue protocol	-

Primary Outcome Measures

Name	Time	Method
Lower extremity muscle oxygenation level measurement	20 minutes	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.
Lower extremity muscle total hemoglobin amount level measurement	20 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Peripheral oxygen saturation measurement	20 minutes	During the fatigue protocol, it will be measured with a finger pulse oximeter attached to the finger
Forced vital capacity (FVC),	5 minutes	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.
Forced expiratory volum in one second (FEV1)	5 minutes	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
Respiratory muscle strength	10 minutes	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.

Trial Locations

Locations (1)

Yedikule Chest Disease Hospital; 🇹🇷 Istanbul, Zeytinburnu, Turkey