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Recruiting NCT05903001

Diaphragmatic Function as a Biomarker

— Observational Dyspnea; Asthmatic COPD Fibrosis Pulmonary Hypertension

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: Diaphragm Ultrasound, Intercostal Muscle Ultrasound, Borg scale, MRC Breathlessness Scale.
Who it may be relevant to
Registry conditions: Dyspnea; Asthmatic, COPD, Fibrosis, Pulmonary Hypertension. Basic parameters: from 18 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
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Diaphragmatic Function as a Biomarker in Patients With Respiratory Diseases

Overview

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.

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

Primary outcome measures

  • Dyspnea Borg scale 1 to 10 [Time frame: 6 months recruiting]
  • Dyspnea Borg scale 1 to 10 [Time frame: follow up 3 months after recruitment]
  • Dyspnea Borg scale 1 to 10 [Time frame: follow up 6 months after recruitment]
  • Dyspnea Borg scale 1 to 10 [Time frame: follow up 12 months after recruitment]
  • Dyspnea Borg scale 1 to 10 [Time frame: follow up 18 months after recruitment]
Secondary outcome measures (12)
  • 6 minute walking distance in m [Time frame: 6 months recruiting]
  • Sit-to stand-test (60 seconds) [Time frame: 6 months recruiting]
  • New York Heart Association (NYHA) classification scale 1 to 4 [Time frame: 6 months recruiting, follow up up to 18 months after last recruitment]
  • Modified Medical Research Council (MRC) Breathlessness Scale 1 to 5 [Time frame: 6 months recruiting, follow up up to 18 months after last recruitment]
  • Chronic Respiratory Questionnaire (CRQ) [Time frame: 6 months recruiting, follow up up to 18 months after last recruitment]
  • COPD Assessment Test (CAT-Questionnaire) from 0 to 40 points. [Time frame: 6 months recruiting, follow up up to 18 months after last recruitment]
  • Global Initiative for Asthma (GINA) classification [Time frame: 6 months recruiting, follow up up to 18 months after last recruitment]
  • Body Plethysmography [Time frame: 6 months recruiting]
  • Diaphragm Thickening Ratio (DTR) in percent [Time frame: 6 months recruiting]
  • Diaphragm thickness at Total lung capacity (TLC) [Time frame: 6 months recruiting]
  • Diaphragm thickness at functional capacity (FRC) [Time frame: 6 months recruiting]
  • Diaphragm ultrasound sniff velocity in cm/s [Time frame: 6 months recruiting]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • RWTH Aachen University Hospital — Aachen

Publications

  • Daher A, Balfanz P, Aetou M, Hartmann B, Muller-Wieland D, Muller T, Marx N, Dreher M, Cornelissen CG. Clinical course of COVID-19 patients needing supplemental oxygen outside the intensive care unit. Sci Rep. 2021 Jan 26;11(1):2256. doi: 10.1038/s41598-021-81444-9. PMID 33500431
  • Daher A, Balfanz P, Cornelissen C, Muller A, Bergs I, Marx N, Muller-Wieland D, Hartmann B, Dreher M, Muller T. Follow up of patients with severe coronavirus disease 2019 (COVID-19): Pulmonary and extrapulmonary disease sequelae. Respir Med. 2020 Nov-Dec;174:106197. doi: 10.1016/j.rmed.2020.106197. Epub 2020 Oct 20. PMID 33120193
  • Balfanz P, Hartmann B, Muller-Wieland D, Kleines M, Hackl D, Kossack N, Kersten A, Cornelissen C, Muller T, Daher A, Stohr R, Bickenbach J, Marx G, Marx N, Dreher M. Early risk markers for severe clinical course and fatal outcome in German patients with COVID-19. PLoS One. 2021 Jan 29;16(1):e0246182. doi: 10.1371/journal.pone.0246182. eCollection 2021. PMID 33513168
  • Spiesshoefer J, Henke C, Herkenrath S, Brix T, Randerath W, Young P, Boentert M. Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation. Respir Physiol Neurobiol. 2019 Aug;266:47-53. doi: 10.1016/j.resp.2019.04.011. Epub 2019 Apr 25. PMID 31029769
  • Spiesshoefer J, Henke C, Herkenrath S, Randerath W, Brix T, Young P, Boentert M. Assessment of Central Drive to the Diaphragm by Twitch Interpolation: Normal Values, Theoretical Considerations, and Future Directions. Respiration. 2019;98(4):283-293. doi: 10.1159/000500726. Epub 2019 Jul 26. PMID 31352459
  • Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12. PMID 32396905

Identifiers

NCT: NCT05903001 · RWTHAachenU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗