Chronic obstructive pulmonary disease
Conditions
Interventions
1) Patients who meet the eligibility criteria will be enrolled and randomly assigned in a 1:1 ratio into the EPT group or the EPT + exercise therapy group. In addition, patients of both groups will in
Sponsors
National Hospital Organization Osaka Toneyama Medical Center
Kitano Hospital, Tazuke Kofukai Medical Research Institute LIAA Tokushima Prefecture Naruto Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with moderate to very severe COPD (FEV1/FVC < 70%, and %FEV1< 80%, i.e., Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification airflow limitation severity, from II 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 (However, patients with no recurrence more than 5 years after treatment are not included in the exclusion criteria) 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 following 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 oxygen extraction (the difference between inspired and expired O2 concentrations (delta FO2)) iv) Respiratory muscle pressure: maximum expiratory pressure (MEP) v) 6-minute walk test: 6-minute walk distance, and Ti/Ttot vi) Oxygen saturation of peripheral artery (SpO2) during the night vii) Eating Assessment Tool (EAT-10) | — |
Countries
Japan
Contacts
Public ContactKeisuke Miki
National Hospital Organization Osaka Toneyama Medical Center Department of Respiratory Medicine
Outcome results
None listed