NCT05903001

Diaphragmatic Function as a Biomarker

Diaphragmatic Function as a Biomarker in Patients With Respiratory Diseases

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of the present project is to comprehensively measure respiratory muscle function and strength in patients with respiratory diseases. The investigators attempt to recruit 800 patients across four disease groups (Asthma, COPD, Fibrosis, and Pulmonary Hypertension) and the investigators intend to measure diaphragm and accessory respiratory muscle function and strength, lung function, and exercise tolerance, as well as the participants' symptom burden during one day at baseline in the investigators' lab. Thereafter, the investigators will follow up on patients by phone 3 months, 6 months, 12 months and 18 months after the investigators have seen them in the investigators' lab. In a small subset of patients (50 overall at most) and in those in whom a recently approved drug based therapy has been initiated (i.e. Sotatercept in PH, Nintedanib in ILD, Brensocatib in Bronchiectasis, Dupilumab in COPD, Anti IL-4/IL 13 or Anti IL 5 antibodies in eosinophilic asthma) follow up will not be by phone only but also in person to repeat the above mentioned non-invasive measurements. Based on these results, not only the association between dyspnea exercise tolerance and diaphragm function in patients with respiratory diseases can be assessed, but also the prognostic significance of diaphragm dysfunction in these patients can be determined. As such, hospitalization and exacerbation requiring the intake of steroids will be assessed and followed up on by phone, and therefore the prognostic significance of diaphragm dysfunction in predicting hospitalization and the intake of steroids can be determined.

Conditions

• Dyspnea; Asthmatic
• COPD
• Fibrosis
• Pulmonary Hypertension
• Asthma
• Dyspnea

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diaphragm Ultrasound	Ultrasound of the Diaphragm at the end of inspiration and expiration
DIAGNOSTIC_TEST	Intercostal Muscle Ultrasound	Ultrasound of the Intercostal Muscles at the end of inspiration and expiration
DIAGNOSTIC_TEST	Borg scale	Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)
DIAGNOSTIC_TEST	MRC Breathlessness Scale	The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.
DIAGNOSTIC_TEST	Respiratory Questionaire	Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)
DIAGNOSTIC_TEST	GINA classification of Asthma	Patients are classified according to the GINA classification of Asthma.
DIAGNOSTIC_TEST	Measurement of respiratory mouth pressure	Inspiratory and expiratory Measurement of respiratory mouth pressure
DIAGNOSTIC_TEST	SNIP	Measurement of Sniff Nasal Inspiratory Pressure
DIAGNOSTIC_TEST	6-minute walking distance	The maximum walking distance achieved in 6 minutes
DIAGNOSTIC_TEST	60 seconds sit-to-stand test	number of repetitions achieved in sitting down and standing up in 60 seconds
DIAGNOSTIC_TEST	Electromyography	electromyography of the muscles of respiration via superficial electrodes
DIAGNOSTIC_TEST	Lung Function	Measurement of lung function via body plethysmography
DIAGNOSTIC_TEST	CAT-Questionnaire	COPD Assessment Test (CAT)
DIAGNOSTIC_TEST	European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group	Patients with pulmonary hypertension are classified according to the ESC/ERS risk group.

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2023-06-15
• Last updated: 2026-01-28

Locations

1 site across 1 country: Germany