Health TrialsbyHealthPanel

Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation

ConditionCOPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIstanbul Medipol University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Respiratory muscle fatigue protocol

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: COPD GroupActive comparator 1 intervention
Group B: Healthy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

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
2

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
3

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.

Time frame
10 minutes
4

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

Time frame
5 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul Medipol University Hospital

Lead sponsor

Saglik Bilimleri Universitesi

Sponsor institution

Source ClinicalTrials.gov
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