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Diaphragmatic Function as a Biomarker

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…

ClinicalTrials.gov IDNCT05903001

PhaseNot Applicable

Enrollment800

SponsorRWTH Aachen University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

Interventions

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

Primary outcomes

Dyspnea Borg scale 1 to 10 (6 months recruiting)
Dyspnea Borg scale 1 to 10 (follow up 3 months after recruitment)
Dyspnea Borg scale 1 to 10 (follow up 6 months after recruitment)
Dyspnea Borg scale 1 to 10 (follow up 12 months after recruitment)
Dyspnea Borg scale 1 to 10 (follow up 18 months after recruitment)

Eligibility information

Inclusion Criteria: * patient has one of the following lung diseases: COPD, bronchial asthma, pulmonary fibrosis, pulmonary hypertension * is 18 years or older * is mentally and physically able to understand the study and to follow instructions * are legally competent * signed declaration of consent Exclusion Criteria: * BMI \> 35 * current or treatments or diseases in the past which could influence the evaluation of the study * Expected lack of willingness to actively participate in study-related measures * alcohol or drug abuse * disc herniation/prolapse * epilepsy * wheelchair bound * in custody due to an official or court order * in a dependent relationship or employment relationship with investigating physician or one of their deputy * emergency inpatient hospital stay within 4 weeks before study-specific examinations

Study locations

RWTH Aachen University Hospital, Aachen, North Rhine-Westphalia 52074 Germany

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.