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RecruitingNCT05903001

Diaphragmatic Function as a Biomarker

Diaphragmatic Function as a Biomarker in Patients With Respiratory Diseases

Sponsor

RWTH Aachen University

Enrollment

800 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

AsthmaDyspneaFibrosisCOPDPulmonary HypertensionDyspnea; Asthmatic

Summary

Dyspnea is among the most common symptoms in patients with respiratory diseases such as Asthma, chronic obstructive pulmonary disease (COPD), Fibrosis, and Pulmonary Hypertension. However, the pathophysiology and underlying mechanisms of dyspnea in patients with respiratory diseases are still poorly understood. Diaphragm dysfunction might be highly prevalent in patients with dyspnea and respiratory diseases. The association of diaphragm function and potential prognostic significance in patients with respiratory diseases has not yet been investigated.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether measuring the movement and strength of the diaphragm (the main breathing muscle) can serve as a useful biomarker to track disease progression and treatment effects in people with chronic lung conditions. **You may be eligible if...** - You are 18 or older - You have been diagnosed with COPD, asthma, pulmonary fibrosis, or pulmonary hypertension - You are mentally and physically able to follow study instructions - You can provide written informed consent **You may NOT be eligible if...** - Your BMI is above 35 - You are starting a new medication during the study that could affect muscle or nerve function - You have a disc herniation/prolapse or epilepsy - You use a wheelchair - You have a relationship (employment or dependency) with the investigating physician - You had an emergency hospital stay within 4 weeks before study assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTDiaphragm Ultrasound

Ultrasound of the Diaphragm at the end of inspiration and expiration

DIAGNOSTIC_TESTIntercostal Muscle Ultrasound

Ultrasound of the Intercostal Muscles at the end of inspiration and expiration

DIAGNOSTIC_TESTBorg scale

Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)

DIAGNOSTIC_TESTMRC Breathlessness Scale

The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.

DIAGNOSTIC_TESTRespiratory Questionaire

Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)

DIAGNOSTIC_TESTGINA classification of Asthma

Patients are classified according to the GINA classification of Asthma.

DIAGNOSTIC_TESTMeasurement of respiratory mouth pressure

Inspiratory and expiratory Measurement of respiratory mouth pressure

DIAGNOSTIC_TESTSNIP

Measurement of Sniff Nasal Inspiratory Pressure

DIAGNOSTIC_TEST6-minute walking distance

The maximum walking distance achieved in 6 minutes

DIAGNOSTIC_TEST60 seconds sit-to-stand test

number of repetitions achieved in sitting down and standing up in 60 seconds

DIAGNOSTIC_TESTElectromyography

electromyography of the muscles of respiration via superficial electrodes

DIAGNOSTIC_TESTLung Function

Measurement of lung function via body plethysmography

DIAGNOSTIC_TESTCAT-Questionnaire

COPD Assessment Test (CAT)

DIAGNOSTIC_TESTEuropean Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group

Patients with pulmonary hypertension are classified according to the ESC/ERS risk group.

Locations(1)

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, Germany

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NCT05903001

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