Diaphragmatic Function as a Biomarker in Patients With Respiratory Diseases
Overview
- Phase
- Not Applicable
- Intervention
- MRC Breathlessness Scale
- Conditions
- Dyspnea; Asthmatic
- Sponsor
- RWTH Aachen University
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Dyspnea Borg scale 1 to 10
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Jens Spießhöfer
PD Dr. med.
RWTH Aachen University
Eligibility Criteria
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
- •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
Arms & Interventions
Patients with Fibrosis
Intervention: MRC Breathlessness Scale
Patients with Fibrosis
Intervention: Respiratory Questionaire
Patients with Fibrosis
Intervention: Measurement of respiratory mouth pressure
Patients with COPD
Intervention: Electromyography
Patients with COPD
Intervention: Lung Function
Patients with COPD
Intervention: CAT-Questionnaire
Patients with Fibrosis
Intervention: Diaphragm Ultrasound
Patients with Fibrosis
Intervention: SNIP
Patients with Fibrosis
Intervention: 6-minute walking distance
Patients with Fibrosis
Intervention: Intercostal Muscle Ultrasound
Patients with Fibrosis
Intervention: Borg scale
Patients with Asthma
Intervention: Diaphragm Ultrasound
Patients with Asthma
Intervention: Intercostal Muscle Ultrasound
Patients with Asthma
Intervention: Borg scale
Patients with Asthma
Intervention: MRC Breathlessness Scale
Patients with Asthma
Intervention: Respiratory Questionaire
Patients with Asthma
Intervention: GINA classification of Asthma
Patients with Asthma
Intervention: Measurement of respiratory mouth pressure
Patients with Asthma
Intervention: SNIP
Patients with Asthma
Intervention: 6-minute walking distance
Patients with Asthma
Intervention: 60 seconds sit-to-stand test
Patients with Asthma
Intervention: Electromyography
Patients with Asthma
Intervention: Lung Function
Patients with COPD
Intervention: Diaphragm Ultrasound
Patients with COPD
Intervention: Intercostal Muscle Ultrasound
Patients with COPD
Intervention: Borg scale
Patients with COPD
Intervention: MRC Breathlessness Scale
Patients with COPD
Intervention: Respiratory Questionaire
Patients with COPD
Intervention: Measurement of respiratory mouth pressure
Patients with COPD
Intervention: SNIP
Patients with COPD
Intervention: 6-minute walking distance
Patients with COPD
Intervention: 60 seconds sit-to-stand test
Patients with Fibrosis
Intervention: 60 seconds sit-to-stand test
Patients with Fibrosis
Intervention: Electromyography
Patients with Fibrosis
Intervention: Lung Function
Patients with Pulmonary Hypertension
Intervention: Diaphragm Ultrasound
Patients with Pulmonary Hypertension
Intervention: Intercostal Muscle Ultrasound
Patients with Pulmonary Hypertension
Intervention: Borg scale
Patients with Pulmonary Hypertension
Intervention: MRC Breathlessness Scale
Patients with Pulmonary Hypertension
Intervention: Respiratory Questionaire
Patients with Pulmonary Hypertension
Intervention: Measurement of respiratory mouth pressure
Patients with Pulmonary Hypertension
Intervention: SNIP
Patients with Pulmonary Hypertension
Intervention: 6-minute walking distance
Patients with Pulmonary Hypertension
Intervention: 60 seconds sit-to-stand test
Patients with Pulmonary Hypertension
Intervention: Electromyography
Patients with Pulmonary Hypertension
Intervention: Lung Function
Patients with Pulmonary Hypertension
Intervention: European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group
Outcomes
Primary Outcomes
Dyspnea Borg scale 1 to 10
Time Frame: follow up 18 months after recruitment
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Dyspnea Borg scale 1 to 10
Time Frame: 6 months recruiting
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Dyspnea Borg scale 1 to 10
Time Frame: follow up 3 months after recruitment
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Dyspnea Borg scale 1 to 10
Time Frame: follow up 6 months after recruitment
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Dyspnea Borg scale 1 to 10
Time Frame: follow up 12 months after recruitment
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Secondary Outcomes
- 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)
- COPD Assessment Test (CAT-Questionnaire) from 0 to 40 points.(6 months recruiting, follow up up to 18 months after last recruitment)
- Diaphragm Thickening Ratio (DTR) in percent(6 months recruiting)
- Diaphragm ultrasound sniff velocity in cm/s(6 months recruiting)
- 6 minute walking distance in m(6 months recruiting)
- Chronic Respiratory Questionnaire (CRQ)(6 months recruiting, follow up up to 18 months after last recruitment)
- Body Plethysmography(6 months recruiting)
- Diaphragm thickness at functional capacity (FRC)(6 months recruiting)
- Global Initiative for Asthma (GINA) classification(6 months recruiting, follow up up to 18 months after last recruitment)
- Diaphragm thickness at Total lung capacity (TLC)(6 months recruiting)
- Intercostal Muscle ultrasound thickness at Total lung capacity (TLC) in cm(6 months recruiting)
- Intercostal Muscle ultrasound thickness at functional capacity (FRC) in cm(6 months recruiting)
- Intercostal Muscle Thickening Ratio in percent(6 months recruiting)
- Maximum Inspiratory Pressure (MIP) in percent predicted(6 months recruiting)
- Maximum Expiratory Pressure (MEP) in percent predicted(6 months recruiting)
- Sniff Nasal Inspiratory Pressure (SNIP) in percent predicted(6 months recruiting)
- Blood Gas Analysis(6 months recruiting)
- Blood Gas Analysis in mmol/l(6 months recruiting)
- Electromyography (EMG)(6 months recruiting)
- Blood Gas Analysis in (I1/s) percent(6 months recruiting)
- Blood Gas Analysis in cmH2O(6 months recruiting)