Dyspnea; Asthmatic, COPD, Fibrosis, Pulmonary Hypertension, Asthma, Dyspnea
Conditions
Keywords
dyspnea, COPD, asthma, fibrosis, pulmonary hypertension, pneumology
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.
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_TESTDiaphragm Ultrasound
Ultrasound of the Diaphragm at the end of inspiration and expiration
DIAGNOSTIC_TESTIntercostal Muscle Ultrasound
Ultrasound of the Intercostal Muscles at the end of inspiration and expiration
DIAGNOSTIC_TESTBorg scale
Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)
DIAGNOSTIC_TESTMRC Breathlessness Scale
The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.
DIAGNOSTIC_TESTRespiratory Questionaire
Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)
DIAGNOSTIC_TESTGINA classification of Asthma
Patients are classified according to the GINA classification of Asthma.
DIAGNOSTIC_TESTMeasurement of respiratory mouth pressure
Inspiratory and expiratory Measurement of respiratory mouth pressure
DIAGNOSTIC_TESTSNIP
Measurement of Sniff Nasal Inspiratory Pressure
DIAGNOSTIC_TEST6-minute walking distance
The maximum walking distance achieved in 6 minutes
DIAGNOSTIC_TEST60 seconds sit-to-stand test
number of repetitions achieved in sitting down and standing up in 60 seconds
DIAGNOSTIC_TESTElectromyography
electromyography of the muscles of respiration via superficial electrodes
DIAGNOSTIC_TESTLung Function
Measurement of lung function via body plethysmography
DIAGNOSTIC_TESTCAT-Questionnaire
COPD Assessment Test (CAT)
DIAGNOSTIC_TESTEuropean Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group
Patients with pulmonary hypertension are classified according to the ESC/ERS risk group.
Sponsors
RWTH Aachen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea Borg scale 1 to 10 | 6 months recruiting | Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walking distance in m | 6 months recruiting | Measurement of achieved walking distance in 6 minutes |
| Sit-to stand-test (60 seconds) | 6 months recruiting | Measurement of achieved repetitions of standing up and sitting down from an initial seated position in 60 seconds. |
| New York Heart Association (NYHA) classification scale 1 to 4 | 6 months recruiting, follow up up to 18 months after last recruitment | Patients are linked to a NYHA degree. Lower scores show fewer dyspnea, higher scores indicate more dyspnea. |
| Modified Medical Research Council (MRC) Breathlessness Scale 1 to 5 | 6 months recruiting, follow up up to 18 months after last recruitment | Patients are assessed and grouped according to their MRC Breathlessness Scale. Lower scores show fewer dyspnea, higher scores indicate more dyspnea. |
| Chronic Respiratory Questionnaire (CRQ) | 6 months recruiting, follow up up to 18 months after last recruitment | 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. |
| COPD Assessment Test (CAT-Questionnaire) from 0 to 40 points. | 6 months recruiting, follow up up to 18 months after last recruitment | Patients are evaluated and placed into the corresponding groups. Lower scores show fewer dyspnea, higher scores indicate more dyspnea. |
| Global Initiative for Asthma (GINA) classification | 6 months recruiting, follow up up to 18 months after last recruitment | Patients are assessed and grouped as mild, moderate, or severe according to the GINA classification. |
| Body Plethysmography | 6 months recruiting | TLC (Total lung capacity) in percent predicted. |
| Diaphragm Thickening Ratio (DTR) in percent | 6 months recruiting | Via ultrasound, the diaphragm thickening ratio (DTR) was calculated as thickness at total lung capacity (TLC) divided by thickness at functional residual capacity (FRC). |
| Diaphragm thickness at Total lung capacity (TLC) | 6 months recruiting | Via ultrasound, the diaphragm thickness at TLC is measured at the maximum point of inspiration. |
| Diaphragm thickness at functional capacity (FRC) | 6 months recruiting | Via ultrasound, the diaphragm thickness at FRC is measured after a normal expiration. |
| Diaphragm ultrasound sniff velocity in cm/s | 6 months recruiting | Via ultrasound, the diaphragm sniff velocity was assessed during tidal breathing and following a maximum sniff. |
| Intercostal Muscle ultrasound thickness at Total lung capacity (TLC) in cm | 6 months recruiting | Via ultrasound, the intercostal thickness at TLC is measured at the maximum point of inspiration. |
| Intercostal Muscle ultrasound thickness at functional capacity (FRC) in cm | 6 months recruiting | Via ultrasound, the intercostal thickness at FRC is measured after a normal expiration. |
| Intercostal Muscle Thickening Ratio in percent | 6 months recruiting | Via ultrasound, the intercostal muscle thickening ratio was calculated as thickness at total lung capacity (TLC) divided by thickness at functional residual capacity (FRC). |
| Maximum Inspiratory Pressure (MIP) in percent predicted | 6 months recruiting | Measurement of Maximum Inspiratory Pressure |
| Maximum Expiratory Pressure (MEP) in percent predicted | 6 months recruiting | Measurement of Maximum Expiratory Pressure |
| Sniff Nasal Inspiratory Pressure (SNIP) in percent predicted | 6 months recruiting | Measurement of Sniff Nasal Inspiratory Pressure |
| Blood Gas Analysis in cmH2O | 6 months recruiting | oxygen partial pressure (pO2) |
| Blood Gas Analysis | 6 months recruiting | pH scale |
| Blood Gas Analysis in mmol/l | 6 months recruiting | Base Excess |
| Blood Gas Analysis in (I1/s) percent | 6 months recruiting | Base Excess |
| Electromyography (EMG) | 6 months recruiting | 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). |
Countries
Germany
Contacts
CONTACTJens Spiesshoefer, MD
STUDY_DIRECTORMichael Dreher, MD
Uniklinik RWTH Aachen
STUDY_CHAIRBinaya Regmi, MD
Uniklinik RWTH Aachen
PRINCIPAL_INVESTIGATORJens Spiesshoefer, MD
Uniklinik RWTH Aachen
STUDY_CHAIRMustafa Elfeturi
Uniklinik RWTH Aachen
STUDY_CHAIRBenedikt Jörn
Uniklinik RWTH Aachen
STUDY_CHAIRFaniry Ratsimba
Uniklinik RWTH Aachen
STUDY_CHAIRFelix Wagner
Uniklinik RWTH Aachen
STUDY_CHAIRMaria Aetou, Dr. med.
RWTH Aachen University Hospital
Outcome results
None listed