Effect of the addition of exercise therapy to expiratory pressure load training in patients with chronic obstructive pulmonary disease: a multicenter, randomized controlled trial
Not Applicable
Recruiting
- Conditions
- Chronic obstructive pulmonary disease
- Registration Number
- JPRN-UMIN000041253
- Lead Sponsor
- ational Hospital Organization Osaka Toneyama Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endurance time, which will be evaluated by constant work rate exercise test during cardiopulmonary exercise testing (CPET)
- Secondary Outcome Measures
Name Time Method 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)