Chronic obstructive pulmonary disease: COPD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient diagnosed as COPD and able to visit as outpatient. 2. Patient whose COPD condition is considered stable by his/her physician in charge. 3. Patient who has dyspnea on exertion due to COPD with Grade1 or higher by MMRC. 4. Patient in stage II or higher by GOLD guideline. "Stable" here means when a COPD patient has no sudden deterioration in his/her symptoms of coughing, expectoration, or dyspnea on exertion during the 3 months period prior to the study outset, and is under a constant medication both in quantity and contents. 5. patients who had not been receiving pulmonary rehabilitation in the previous 6 months.
Exclusion criteria
Exclusion criteria: 1. Patient who has heart disease (except for cor pulmonale), collagen disease (such as RA, PM/DM, etc.), cancer, severe mental disorders, or other severe complications. 2. Patient who is currently under pulmonary rehabilitation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QoL of COPD patients will be assessed before and after 52 weeks from baseline using the St George Respiratory Questionnaire (SGRQ total domain). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints 1. SGRQ (Total) will be assessed before and after 12 weeks from baseline. 2. SGRQ (Symptom, Activity, Impact) will be assessed before and after 12 and 52 weeks from baseline. 3. 6-minute walk test (dyspnea on exertion (modified Borg scale), walking distance, oxygen saturation (lowest), pulse rate (highest), and lower extremity fatigue (modified Borg scale)) will be assessed at 12 and 52 weeks from baseline. | — |
Countries
Japan
Contacts
Kitano hospital, the tazuke kofukai medical research institute Division of Respiratory Medicine, Respiratory Disease Center