Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2023-07-01
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with Asthma
Diaphragm Ultrasound
Ultrasound of the Diaphragm at the end of inspiration and expiration
Intercostal Muscle Ultrasound
Ultrasound of the Intercostal Muscles at the end of inspiration and expiration
Borg scale
Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)
MRC Breathlessness Scale
The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.
Respiratory Questionaire
Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)
GINA classification of Asthma
Patients are classified according to the GINA classification of Asthma.
Measurement of respiratory mouth pressure
Inspiratory and expiratory Measurement of respiratory mouth pressure
SNIP
Measurement of Sniff Nasal Inspiratory Pressure
6-minute walking distance
The maximum walking distance achieved in 6 minutes
60 seconds sit-to-stand test
number of repetitions achieved in sitting down and standing up in 60 seconds
Electromyography
electromyography of the muscles of respiration via superficial electrodes
Lung Function
Measurement of lung function via body plethysmography
Patients with COPD
Diaphragm Ultrasound
Ultrasound of the Diaphragm at the end of inspiration and expiration
Intercostal Muscle Ultrasound
Ultrasound of the Intercostal Muscles at the end of inspiration and expiration
Borg scale
Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)
MRC Breathlessness Scale
The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.
Respiratory Questionaire
Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)
Measurement of respiratory mouth pressure
Inspiratory and expiratory Measurement of respiratory mouth pressure
SNIP
Measurement of Sniff Nasal Inspiratory Pressure
6-minute walking distance
The maximum walking distance achieved in 6 minutes
60 seconds sit-to-stand test
number of repetitions achieved in sitting down and standing up in 60 seconds
Electromyography
electromyography of the muscles of respiration via superficial electrodes
Lung Function
Measurement of lung function via body plethysmography
CAT-Questionnaire
COPD Assessment Test (CAT)
Patients with Fibrosis
Diaphragm Ultrasound
Ultrasound of the Diaphragm at the end of inspiration and expiration
Intercostal Muscle Ultrasound
Ultrasound of the Intercostal Muscles at the end of inspiration and expiration
Borg scale
Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)
MRC Breathlessness Scale
The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.
Respiratory Questionaire
Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)
Measurement of respiratory mouth pressure
Inspiratory and expiratory Measurement of respiratory mouth pressure
SNIP
Measurement of Sniff Nasal Inspiratory Pressure
6-minute walking distance
The maximum walking distance achieved in 6 minutes
60 seconds sit-to-stand test
number of repetitions achieved in sitting down and standing up in 60 seconds
Electromyography
electromyography of the muscles of respiration via superficial electrodes
Lung Function
Measurement of lung function via body plethysmography
Patients with Pulmonary Hypertension
Diaphragm Ultrasound
Ultrasound of the Diaphragm at the end of inspiration and expiration
Intercostal Muscle Ultrasound
Ultrasound of the Intercostal Muscles at the end of inspiration and expiration
Borg scale
Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)
MRC Breathlessness Scale
The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.
Respiratory Questionaire
Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)
Measurement of respiratory mouth pressure
Inspiratory and expiratory Measurement of respiratory mouth pressure
SNIP
Measurement of Sniff Nasal Inspiratory Pressure
6-minute walking distance
The maximum walking distance achieved in 6 minutes
60 seconds sit-to-stand test
number of repetitions achieved in sitting down and standing up in 60 seconds
Electromyography
electromyography of the muscles of respiration via superficial electrodes
Lung Function
Measurement of lung function via body plethysmography
European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group
Patients with pulmonary hypertension are classified according to the ESC/ERS risk group.
Interventions
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Diaphragm Ultrasound
Ultrasound of the Diaphragm at the end of inspiration and expiration
Intercostal Muscle Ultrasound
Ultrasound of the Intercostal Muscles at the end of inspiration and expiration
Borg scale
Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)
MRC Breathlessness Scale
The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.
Respiratory Questionaire
Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)
GINA classification of Asthma
Patients are classified according to the GINA classification of Asthma.
Measurement of respiratory mouth pressure
Inspiratory and expiratory Measurement of respiratory mouth pressure
SNIP
Measurement of Sniff Nasal Inspiratory Pressure
6-minute walking distance
The maximum walking distance achieved in 6 minutes
60 seconds sit-to-stand test
number of repetitions achieved in sitting down and standing up in 60 seconds
Electromyography
electromyography of the muscles of respiration via superficial electrodes
Lung Function
Measurement of lung function via body plethysmography
CAT-Questionnaire
COPD Assessment Test (CAT)
European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group
Patients with pulmonary hypertension are classified according to the ESC/ERS risk group.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Jens Spießhöfer
PD Dr. med.
Principal Investigators
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Michael Dreher, MD
Role: STUDY_DIRECTOR
Uniklinik RWTH Aachen
Binaya Regmi, MD
Role: STUDY_CHAIR
Uniklinik RWTH Aachen
Jens Spiesshoefer, MD
Role: PRINCIPAL_INVESTIGATOR
Uniklinik RWTH Aachen
Mustafa Elfeturi
Role: STUDY_CHAIR
Uniklinik RWTH Aachen
Benedikt Jörn
Role: STUDY_CHAIR
Uniklinik RWTH Aachen
Faniry Ratsimba
Role: STUDY_CHAIR
Uniklinik RWTH Aachen
Felix Wagner
Role: STUDY_CHAIR
Uniklinik RWTH Aachen
Locations
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RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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RWTHAachenU
Identifier Type: -
Identifier Source: org_study_id