Diaphragmatic Function as a Biomarker

NCT ID: NCT05903001

Last Updated: 2023-11-22

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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. 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.

Conditions

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Dyspnea; Asthmatic COPD Fibrosis Pulmonary Hypertension Asthma Dyspnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Asthma

Diaphragm Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound of the Diaphragm at the end of inspiration and expiration

Intercostal Muscle Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Borg scale

Intervention Type DIAGNOSTIC_TEST

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

MRC Breathlessness Scale

Intervention Type DIAGNOSTIC_TEST

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

Respiratory Questionaire

Intervention Type DIAGNOSTIC_TEST

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

GINA classification of Asthma

Intervention Type DIAGNOSTIC_TEST

Patients are classified according to the GINA classification of Asthma.

Measurement of respiratory mouth pressure

Intervention Type DIAGNOSTIC_TEST

Inspiratory and expiratory Measurement of respiratory mouth pressure

SNIP

Intervention Type DIAGNOSTIC_TEST

Measurement of Sniff Nasal Inspiratory Pressure

6-minute walking distance

Intervention Type DIAGNOSTIC_TEST

The maximum walking distance achieved in 6 minutes

60 seconds sit-to-stand test

Intervention Type DIAGNOSTIC_TEST

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

Electromyography

Intervention Type DIAGNOSTIC_TEST

electromyography of the muscles of respiration via superficial electrodes

Lung Function

Intervention Type DIAGNOSTIC_TEST

Measurement of lung function via body plethysmography

Patients with COPD

Diaphragm Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound of the Diaphragm at the end of inspiration and expiration

Intercostal Muscle Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Borg scale

Intervention Type DIAGNOSTIC_TEST

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

MRC Breathlessness Scale

Intervention Type DIAGNOSTIC_TEST

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

Respiratory Questionaire

Intervention Type DIAGNOSTIC_TEST

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

Measurement of respiratory mouth pressure

Intervention Type DIAGNOSTIC_TEST

Inspiratory and expiratory Measurement of respiratory mouth pressure

SNIP

Intervention Type DIAGNOSTIC_TEST

Measurement of Sniff Nasal Inspiratory Pressure

6-minute walking distance

Intervention Type DIAGNOSTIC_TEST

The maximum walking distance achieved in 6 minutes

60 seconds sit-to-stand test

Intervention Type DIAGNOSTIC_TEST

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

Electromyography

Intervention Type DIAGNOSTIC_TEST

electromyography of the muscles of respiration via superficial electrodes

Lung Function

Intervention Type DIAGNOSTIC_TEST

Measurement of lung function via body plethysmography

CAT-Questionnaire

Intervention Type DIAGNOSTIC_TEST

COPD Assessment Test (CAT)

Patients with Fibrosis

Diaphragm Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound of the Diaphragm at the end of inspiration and expiration

Intercostal Muscle Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Borg scale

Intervention Type DIAGNOSTIC_TEST

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

MRC Breathlessness Scale

Intervention Type DIAGNOSTIC_TEST

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

Respiratory Questionaire

Intervention Type DIAGNOSTIC_TEST

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

Measurement of respiratory mouth pressure

Intervention Type DIAGNOSTIC_TEST

Inspiratory and expiratory Measurement of respiratory mouth pressure

SNIP

Intervention Type DIAGNOSTIC_TEST

Measurement of Sniff Nasal Inspiratory Pressure

6-minute walking distance

Intervention Type DIAGNOSTIC_TEST

The maximum walking distance achieved in 6 minutes

60 seconds sit-to-stand test

Intervention Type DIAGNOSTIC_TEST

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

Electromyography

Intervention Type DIAGNOSTIC_TEST

electromyography of the muscles of respiration via superficial electrodes

Lung Function

Intervention Type DIAGNOSTIC_TEST

Measurement of lung function via body plethysmography

Patients with Pulmonary Hypertension

Diaphragm Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound of the Diaphragm at the end of inspiration and expiration

Intercostal Muscle Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Borg scale

Intervention Type DIAGNOSTIC_TEST

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

MRC Breathlessness Scale

Intervention Type DIAGNOSTIC_TEST

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

Respiratory Questionaire

Intervention Type DIAGNOSTIC_TEST

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

Measurement of respiratory mouth pressure

Intervention Type DIAGNOSTIC_TEST

Inspiratory and expiratory Measurement of respiratory mouth pressure

SNIP

Intervention Type DIAGNOSTIC_TEST

Measurement of Sniff Nasal Inspiratory Pressure

6-minute walking distance

Intervention Type DIAGNOSTIC_TEST

The maximum walking distance achieved in 6 minutes

60 seconds sit-to-stand test

Intervention Type DIAGNOSTIC_TEST

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

Electromyography

Intervention Type DIAGNOSTIC_TEST

electromyography of the muscles of respiration via superficial electrodes

Lung Function

Intervention Type DIAGNOSTIC_TEST

Measurement of lung function via body plethysmography

European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Intercostal Muscle Ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Borg scale

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

Intervention Type DIAGNOSTIC_TEST

MRC Breathlessness Scale

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

Intervention Type DIAGNOSTIC_TEST

Respiratory Questionaire

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

Intervention Type DIAGNOSTIC_TEST

GINA classification of Asthma

Patients are classified according to the GINA classification of Asthma.

Intervention Type DIAGNOSTIC_TEST

Measurement of respiratory mouth pressure

Inspiratory and expiratory Measurement of respiratory mouth pressure

Intervention Type DIAGNOSTIC_TEST

SNIP

Measurement of Sniff Nasal Inspiratory Pressure

Intervention Type DIAGNOSTIC_TEST

6-minute walking distance

The maximum walking distance achieved in 6 minutes

Intervention Type DIAGNOSTIC_TEST

60 seconds sit-to-stand test

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

Intervention Type DIAGNOSTIC_TEST

Electromyography

electromyography of the muscles of respiration via superficial electrodes

Intervention Type DIAGNOSTIC_TEST

Lung Function

Measurement of lung function via body plethysmography

Intervention Type DIAGNOSTIC_TEST

CAT-Questionnaire

COPD Assessment Test (CAT)

Intervention Type DIAGNOSTIC_TEST

European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group

Patients with pulmonary hypertension are classified according to the ESC/ERS risk group.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Jens Spießhöfer

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jens Spiesshoefer, MD

Role: CONTACT

0049 2418037036

Facility Contacts

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Jens Spiesshoefer, PhD

Role: primary

+492418037036

Binaya Regmi, MD

Role: backup

+492418037065

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.

Reference Type BACKGROUND
PMID: 33500431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33120193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33513168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31029769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31352459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32396905 (View on PubMed)

Other Identifiers

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RWTHAachenU

Identifier Type: -

Identifier Source: org_study_id