Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06217276
• Other study ID #: Respiratory muscle fatigue&VL
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: January 2024
• Source: Istanbul Medipol University Hospital
• Contact: ESRA PEHLIVAN
• Phone: 09050585279
• Email: fztesrakambur[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Fatigue

Intervention

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.

Locations

Country	Name	City	State
Turkey	Yedikule Chest Disease Hospital	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Peripheral oxygen saturation measurement	During the fatigue protocol, it will be measured with a finger pulse oximeter attached to the finger	20 minutes
Secondary	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
Secondary	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
Secondary	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