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Diaphragmatic Function as a Biomarker

ConditionsDyspnea; AsthmaticCOPDFibrosisPulmonary HypertensionAsthmaDyspnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRWTH Aachen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

800 patients, 4 groups

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Diaphragm Ultrasound

    Diagnostic test

    Ultrasound of the Diaphragm at the end of inspiration and expiration

  • Intercostal Muscle Ultrasound

    Diagnostic test

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

  • Borg scale

    Diagnostic test

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

  • MRC Breathlessness Scale

    Diagnostic test

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

  • Respiratory Questionaire

    Diagnostic test

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

  • GINA classification of Asthma

    Diagnostic test

    Patients are classified according to the GINA classification of Asthma.

  • Measurement of respiratory mouth pressure

    Diagnostic test

    Inspiratory and expiratory Measurement of respiratory mouth pressure

  • SNIP

    Diagnostic test

    Measurement of Sniff Nasal Inspiratory Pressure

  • 6-minute walking distance

    Diagnostic test

    The maximum walking distance achieved in 6 minutes

  • 60 seconds sit-to-stand test

    Diagnostic test

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

  • Electromyography

    Diagnostic test

    electromyography of the muscles of respiration via superficial electrodes

  • Lung Function

    Diagnostic test

    Measurement of lung function via body plethysmography

  • CAT-Questionnaire

    Diagnostic test

    COPD Assessment Test (CAT)

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

    Diagnostic test

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

Treatment groups

800 Participants
are divided into 4 treatment groups
Group A: Patients with Asthma12 interventions
Group B: Patients with COPD12 interventions
Group C: Patients with Fibrosis11 interventions
Group D: Patients with Pulmonary Hypertension12 interventions

Trial outcomes

Primary outcomes

1

Dyspnea Borg scale 1 to 10

Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.

Time frame
6 months recruiting
2

Dyspnea Borg scale 1 to 10

Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.

Time frame
follow up 3 months after recruitment
3

Dyspnea Borg scale 1 to 10

Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.

Time frame
follow up 6 months after recruitment
4

Dyspnea Borg scale 1 to 10

Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.

Time frame
follow up 12 months after recruitment

Secondary outcomes

1

6 minute walking distance in m

Measurement of achieved walking distance in 6 minutes

Time frame
6 months recruiting
2

Sit-to stand-test (60 seconds)

Measurement of achieved repetitions of standing up and sitting down from an initial seated position in 60 seconds.

Time frame
6 months recruiting
3

New York Heart Association (NYHA) classification scale 1 to 4

Patients are linked to a NYHA degree. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.

Time frame
6 months recruiting, follow up up to 18 months after last recruitment
4

Modified Medical Research Council (MRC) Breathlessness Scale 1 to 5

Patients are assessed and grouped according to their MRC Breathlessness Scale. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.

Time frame
6 months recruiting, follow up up to 18 months after last recruitment

Other outcomes

Sponsors and contacts

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

RWTH Aachen University

Lead sponsor

Source ClinicalTrials.gov
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