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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Asthma |
| ||
| Patients with COPD |
| ||
| Patients with Fibrosis |
| ||
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragm Ultrasound | Diagnostic Test | Ultrasound of the Diaphragm at the end of inspiration and expiration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walking distance in m | Measurement of achieved walking distance in 6 minutes | 6 months recruiting |
| Sit-to stand-test (60 seconds) | Measurement of achieved repetitions of standing up and sitting down from an initial seated position in 60 seconds. |
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Inclusion Criteria:
Exclusion Criteria:
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800 patients, 4 groups
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens Spiesshoefer, MD | Contact | 0049 2418037036 | jspiesshoefer@ukaachen.de |
| Name | Affiliation | Role |
|---|---|---|
| Michael Dreher, MD | Uniklinik RWTH Aachen | Study Director |
| Binaya Regmi, MD | Uniklinik RWTH Aachen | Study Chair |
| Jens Spiesshoefer, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RWTH Aachen University Hospital | Recruiting | Aachen | North Rhine-Westphalia | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33500431 | Background | 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. | |
| 33120193 | 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. |
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| Patients with Pulmonary Hypertension |
|
| 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. |
|
| 6 months recruiting |
| 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. | 6 months recruiting, follow up up to 18 months after last recruitment |
| 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. | 6 months recruiting, follow up up to 18 months after last recruitment |
| Chronic Respiratory Questionnaire (CRQ) | Assessments of different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain) in a standardized questionnaire on a scale from 1 to 7. The scores for each question of each dimension are added together and divided by the number of completed questions in each domain. In general, higher scores mean a worse outcome and lower scores mean a better outcome. For the dyspnea domain for example, a high score means that patients have less dyspnea, and a low score means that patients have more dyspnea. | 6 months recruiting, follow up up to 18 months after last recruitment |
| COPD Assessment Test (CAT-Questionnaire) from 0 to 40 points. | Patients are evaluated and placed into the corresponding groups. Lower scores show fewer dyspnea, higher scores indicate more dyspnea. | 6 months recruiting, follow up up to 18 months after last recruitment |
| Global Initiative for Asthma (GINA) classification | Patients are assessed and grouped as mild, moderate, or severe according to the GINA classification. | 6 months recruiting, follow up up to 18 months after last recruitment |
| Body Plethysmography | TLC (Total lung capacity) in percent predicted. | 6 months recruiting |
| Diaphragm Thickening Ratio (DTR) in percent | Via ultrasound, the diaphragm thickening ratio (DTR) was calculated as thickness at total lung capacity (TLC) divided by thickness at functional residual capacity (FRC). | 6 months recruiting |
| Diaphragm thickness at Total lung capacity (TLC) | Via ultrasound, the diaphragm thickness at TLC is measured at the maximum point of inspiration. | 6 months recruiting |
| Diaphragm thickness at functional capacity (FRC) | Via ultrasound, the diaphragm thickness at FRC is measured after a normal expiration. | 6 months recruiting |
| Diaphragm ultrasound sniff velocity in cm/s | Via ultrasound, the diaphragm sniff velocity was assessed during tidal breathing and following a maximum sniff. | 6 months recruiting |
| Intercostal Muscle ultrasound thickness at Total lung capacity (TLC) in cm | Via ultrasound, the intercostal thickness at TLC is measured at the maximum point of inspiration. | 6 months recruiting |
| Intercostal Muscle ultrasound thickness at functional capacity (FRC) in cm | Via ultrasound, the intercostal thickness at FRC is measured after a normal expiration. | 6 months recruiting |
| Intercostal Muscle Thickening Ratio in percent | Via ultrasound, the intercostal muscle thickening ratio was calculated as thickness at total lung capacity (TLC) divided by thickness at functional residual capacity (FRC). | 6 months recruiting |
| Maximum Inspiratory Pressure (MIP) in percent predicted | Measurement of Maximum Inspiratory Pressure | 6 months recruiting |
| Maximum Expiratory Pressure (MEP) in percent predicted | Measurement of Maximum Expiratory Pressure | 6 months recruiting |
| Sniff Nasal Inspiratory Pressure (SNIP) in percent predicted | Measurement of Sniff Nasal Inspiratory Pressure | 6 months recruiting |
| Blood Gas Analysis in cmH2O | oxygen partial pressure (pO2) | 6 months recruiting |
| Blood Gas Analysis in cmH2O | carbon dioxide partial pressure (pCO2) | 6 months recruiting |
| Blood Gas Analysis | pH scale | 6 months recruiting |
| Blood Gas Analysis in mmol/l | Base Excess | 6 months recruiting |
| Blood Gas Analysis in (I1/s) percent | Base Excess | 6 months recruiting |
| Electromyography (EMG) | Measurement of electrical activity during different breathing maneuvers (Sniff, Cough, Valsalva, Mueller) via superficial electrodes placed on the diaphragm and accessory respiratory muscles (Sternocleidomastoideus muscle, intercostal muscles). | 6 months recruiting |
| 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 |
| 33513168 | 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. |
| 31029769 | 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. |
| 31352459 | 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. |
| 32396905 | 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. |
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D005355 | Fibrosis |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004576 | Electromyography |
| D012119 | Respiration |
| ID | Term |
|---|---|
| D004568 | Electrodiagnosis |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009213 | Myography |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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