Diaphragmatic Function as a Biomarker in Patients With Respiratory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Dyspnea Borg scale 1 to 10
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patients with Fibrosis
干预措施: MRC Breathlessness Scale (Diagnostic Test)
Patients with Fibrosis
干预措施: Respiratory Questionaire (Diagnostic Test)
Patients with Fibrosis
干预措施: Measurement of respiratory mouth pressure (Diagnostic Test)
Patients with COPD
干预措施: Electromyography (Diagnostic Test)
Patients with COPD
干预措施: Lung Function (Diagnostic Test)
Patients with COPD
干预措施: CAT-Questionnaire (Diagnostic Test)
Patients with Fibrosis
干预措施: Diaphragm Ultrasound (Diagnostic Test)
Patients with Fibrosis
干预措施: SNIP (Diagnostic Test)
Patients with Fibrosis
干预措施: 6-minute walking distance (Diagnostic Test)
Patients with Fibrosis
干预措施: Intercostal Muscle Ultrasound (Diagnostic Test)
Patients with Fibrosis
干预措施: Borg scale (Diagnostic Test)
Patients with Asthma
干预措施: Diaphragm Ultrasound (Diagnostic Test)
Patients with Asthma
干预措施: Intercostal Muscle Ultrasound (Diagnostic Test)
Patients with Asthma
干预措施: Borg scale (Diagnostic Test)
Patients with Asthma
干预措施: MRC Breathlessness Scale (Diagnostic Test)
Patients with Asthma
干预措施: Respiratory Questionaire (Diagnostic Test)
Patients with Asthma
干预措施: GINA classification of Asthma (Diagnostic Test)
Patients with Asthma
干预措施: Measurement of respiratory mouth pressure (Diagnostic Test)
Patients with Asthma
干预措施: SNIP (Diagnostic Test)
Patients with Asthma
干预措施: 6-minute walking distance (Diagnostic Test)
Patients with Asthma
干预措施: 60 seconds sit-to-stand test (Diagnostic Test)
Patients with Asthma
干预措施: Electromyography (Diagnostic Test)
Patients with Asthma
干预措施: Lung Function (Diagnostic Test)
Patients with COPD
干预措施: Diaphragm Ultrasound (Diagnostic Test)
Patients with COPD
干预措施: Intercostal Muscle Ultrasound (Diagnostic Test)
Patients with COPD
干预措施: Borg scale (Diagnostic Test)
Patients with COPD
干预措施: MRC Breathlessness Scale (Diagnostic Test)
Patients with COPD
干预措施: Respiratory Questionaire (Diagnostic Test)
Patients with COPD
干预措施: Measurement of respiratory mouth pressure (Diagnostic Test)
Patients with COPD
干预措施: SNIP (Diagnostic Test)
Patients with COPD
干预措施: 6-minute walking distance (Diagnostic Test)
Patients with COPD
干预措施: 60 seconds sit-to-stand test (Diagnostic Test)
Patients with Fibrosis
干预措施: 60 seconds sit-to-stand test (Diagnostic Test)
Patients with Fibrosis
干预措施: Electromyography (Diagnostic Test)
Patients with Fibrosis
干预措施: Lung Function (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: Diaphragm Ultrasound (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: Intercostal Muscle Ultrasound (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: Borg scale (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: MRC Breathlessness Scale (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: Respiratory Questionaire (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: Measurement of respiratory mouth pressure (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: SNIP (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: 6-minute walking distance (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: 60 seconds sit-to-stand test (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: Electromyography (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: Lung Function (Diagnostic Test)
Patients with Pulmonary Hypertension
干预措施: European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group (Diagnostic Test)
结局指标
主要结局
Dyspnea Borg scale 1 to 10
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Jens Spießhöfer
PD Dr. med.
RWTH Aachen University