Diaphragmatic Function as a Biomarker

NCT05903001 | Recruiting

• 1 other identifier: RWTHAachenU
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

dyspnea; COPD; asthma; fibrosis; pulmonary hypertension; pneumology

Outcome Measures

Primary Outcomes (5)

• 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.

  6 months recruiting

• 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.

  follow up 3 months after recruitment

• 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.

  follow up 6 months after recruitment

• 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.

  follow up 12 months after recruitment

• 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.

  follow up 18 months after recruitment

Secondary Outcomes (24)

• 6 minute walking distance in m

  6 months recruiting

• Sit-to stand-test (60 seconds)

  6 months recruiting

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

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

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

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

• Chronic Respiratory Questionnaire (CRQ)

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

Study Arms (4)

Patients with Asthma

Diagnostic Test: Diaphragm Ultrasound; Diagnostic Test: Intercostal Muscle Ultrasound; Diagnostic Test: Borg scale; Diagnostic Test: MRC Breathlessness Scale; Diagnostic Test: Respiratory Questionaire; Diagnostic Test: GINA classification of Asthma; Diagnostic Test: Measurement of respiratory mouth pressure; Diagnostic Test: SNIP; Diagnostic Test: 6-minute walking distance; Diagnostic Test: 60 seconds sit-to-stand test; Diagnostic Test: Electromyography; Diagnostic Test: Lung Function

Patients with COPD

Diagnostic Test: Diaphragm Ultrasound; Diagnostic Test: Intercostal Muscle Ultrasound; Diagnostic Test: Borg scale; Diagnostic Test: MRC Breathlessness Scale; Diagnostic Test: Respiratory Questionaire; Diagnostic Test: Measurement of respiratory mouth pressure; Diagnostic Test: SNIP; Diagnostic Test: 6-minute walking distance; Diagnostic Test: 60 seconds sit-to-stand test; Diagnostic Test: Electromyography; Diagnostic Test: Lung Function; Diagnostic Test: CAT-Questionnaire

Patients with Fibrosis

Diagnostic Test: Diaphragm Ultrasound; Diagnostic Test: Intercostal Muscle Ultrasound; Diagnostic Test: Borg scale; Diagnostic Test: MRC Breathlessness Scale; Diagnostic Test: Respiratory Questionaire; Diagnostic Test: Measurement of respiratory mouth pressure; Diagnostic Test: SNIP; Diagnostic Test: 6-minute walking distance; Diagnostic Test: 60 seconds sit-to-stand test; Diagnostic Test: Electromyography; Diagnostic Test: Lung Function

Patients with Pulmonary Hypertension

Diagnostic Test: Diaphragm Ultrasound; Diagnostic Test: Intercostal Muscle Ultrasound; Diagnostic Test: Borg scale; Diagnostic Test: MRC Breathlessness Scale; Diagnostic Test: Respiratory Questionaire; Diagnostic Test: Measurement of respiratory mouth pressure; Diagnostic Test: SNIP; Diagnostic Test: 6-minute walking distance; Diagnostic Test: 60 seconds sit-to-stand test; Diagnostic Test: Electromyography; Diagnostic Test: Lung Function; Diagnostic Test: European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group

Interventions

Respiratory Questionaire DIAGNOSTIC_TEST

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

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

GINA classification of Asthma DIAGNOSTIC_TEST

Patients are classified according to the GINA classification of Asthma.

Patients with Asthma

Measurement of respiratory mouth pressure DIAGNOSTIC_TEST

Inspiratory and expiratory Measurement of respiratory mouth pressure

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

SNIP DIAGNOSTIC_TEST

Measurement of Sniff Nasal Inspiratory Pressure

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

6-minute walking distance DIAGNOSTIC_TEST

The maximum walking distance achieved in 6 minutes

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

Electromyography DIAGNOSTIC_TEST

electromyography of the muscles of respiration via superficial electrodes

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

CAT-Questionnaire DIAGNOSTIC_TEST

COPD Assessment Test (CAT)

Patients with COPD

Diaphragm Ultrasound DIAGNOSTIC_TEST

Ultrasound of the Diaphragm at the end of inspiration and expiration

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

Intercostal Muscle Ultrasound DIAGNOSTIC_TEST

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

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

Borg scale DIAGNOSTIC_TEST

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

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

MRC Breathlessness Scale DIAGNOSTIC_TEST

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

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

60 seconds sit-to-stand test DIAGNOSTIC_TEST

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

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

Lung Function DIAGNOSTIC_TEST

Measurement of lung function via body plethysmography

Patients with Asthma; Patients with COPD; Patients with Fibrosis; Patients with Pulmonary Hypertension

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.

Patients with Pulmonary Hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

800 patients, 4 groups

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Dyspnea; Asthma; Pulmonary Disease, Chronic Obstructive; Fibrosis; Hypertension, Pulmonary

Interventions

Electromyography; Respiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Michael Dreher, MD

  Uniklinik RWTH Aachen

  STUDY DIRECTOR

• Binaya Regmi, MD

  Uniklinik RWTH Aachen

  STUDY CHAIR

• Jens Spiesshoefer, MD

  Uniklinik RWTH Aachen

  PRINCIPAL INVESTIGATOR

• Mustafa Elfeturi

  Uniklinik RWTH Aachen

  STUDY CHAIR

• Benedikt Jörn

  Uniklinik RWTH Aachen

  STUDY CHAIR

• Faniry Ratsimba

  Uniklinik RWTH Aachen

  STUDY CHAIR

• Felix Wagner

  Uniklinik RWTH Aachen

  STUDY CHAIR

• Maria Aetou, Dr. med.

  RWTH Aachen University Hospital

  STUDY CHAIR

Central Study Contacts

Jens Spiesshoefer, MD

CONTACT

0049 2418037036; jspiesshoefer@ukaachen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 15, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

DE (1)