Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Respiratory muscle fatigue protocol.
- Who it may be relevant to
- Registry conditions: COPD. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Examining the Relationship Between Respiratory Muscle Fatigue and Lower Extremity Muscle Oxygenation in Chronic Obstructive Pulmonary Disease Patients.
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.
Interventions
- 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 measuremen
Primary outcome measures
- Lower extremity muscle oxygenation level measurement [Time frame: 20 minutes]
- Lower extremity muscle total hemoglobin amount level measurement [Time frame: 20 minutes]
Secondary outcome measures (4)
- Peripheral oxygen saturation measurement [Time frame: 20 minutes]
- Forced vital capacity (FVC), [Time frame: 5 minutes]
- Respiratory muscle strength [Time frame: 10 minutes]
- Forced expiratory volum in one second (FEV1) [Time frame: 5 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Turkey (Türkiye) · 1 center
- Yedikule Chest Disease Hospital — Istanbul
Identifiers
NCT: NCT06217276 · Respiratory muscle fatigue&VL