Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation

Istanbul Medipol University Hospital30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

COPD

Interventions

Respiratory muscle fatigue protocolOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 20 minutes

Secondary Outcomes

Peripheral oxygen saturation measurement

During the fatigue protocol, it will be measured with a finger pulse oximeter attached to the finger

Time frame: 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.

Time frame: 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.

Central Contacts

ESRA PEHLİVAN

CONTACT

09050585279 fztesrakambur@yahoo.com

Data from ClinicalTrials.gov

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