Chronic obstructive pulmonary disease
Conditions
Interventions
Patients who meet the eligibility criteria will be enrolled and randomly assigned in a 1:1 ratio to be classified into the EPT group or the control group. In addition, patients in both groups will be
Sponsors
National Hospital Organization Osaka Toneyama Medical Center
Respiratory Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with COPD (FEV1/FVC < 70%, i.e., Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification airflow limitation severity, from I to IV) 2) Patients whose conditions are stable and who are able to tolerate cardiopulmonary exercise testing to ensure adequate evaluation 3) Patients who have signed the agreement for participation in this study
Exclusion criteria
Exclusion criteria: 1) Patients with malignant tumors 2) Patients with active infection 3) Patients with severe heart disease 4) Patients with asthma 5) Patients whose drug regimen was changed during this study 6) Patients who are receiving pulmonary rehabilitation 7) Patients who receive oxygen therapy during exercise 8) Patients with a history of pneumothorax or who have a giant bulla with a high risk of developing pneumothorax 9) In addition to the above exclusion criteria, patients judged by their physician to be ineligible to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endurance time, which will be evaluated by constant work rate exercise test during cardiopulmonary exercise testing (CPET) in patients with severe and very severe COPD. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Endurance time, which will be evaluated by constant work rate exercise test during CPET in patients with mild and moderate COPD. 2. In patients with severe and very severe COPD, or with mild and moderate COPD: i) Symptom (SGRQ score: Total domain, Symptom, Activity, Impact) ii) Respiratory function (RV, RV/TLC) iii) During CPET, which will consist of incremental exercise test or constant work rate exercise test, the parameters: oxygen uptake (VO2), minute ventilation (VE), ventilatory equivalent, physiologic dead space/tidal volume ratio (VD/VT), expiratory tidal volume (VTex), mean expiratory flow (VTex/Te), inspiratory tidal volume (VTin), VTin-VTex, ratio of inspiratory time to total respiratory cycle time (Ti/Ttot) dyspnea (Borg scale), and collapse ratio of vocal cords using laryngeal scope, will be evaluated during exercise. iv) Respiratory muscle pressure: maximum expiratory pressure (MEP) v) 6-minute walk test: 6-minute walk distance vi) Oxygen saturation of peripheral artery (SpO2) during the night | — |
Countries
Japan
Contacts
Public ContactKeisuke Miki
National Hospital Organization Osaka Toneyama Medical Center Department of Respiratory Medicine
Outcome results
None listed