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NCT Number: NCT06217276

Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Esra Pehlivan

CONTACT

[email protected]

+902124090200

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Lower extremity muscle oxygenation level measurement

    Time frame: 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.

  2. Lower extremity muscle total hemoglobin amount level measurement

    Time frame: 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 outcomes

  1. Peripheral oxygen saturation measurement

    Time frame: 20 minutes

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

  2. Forced vital capacity (FVC),

    Time frame: 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.

  3. Respiratory muscle strength

    Time frame: 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.

  4. Forced expiratory volum in one second (FEV1)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

ESRA PEHLİVAN

CONTACT

[email protected]

09050585279

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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