COPD
Conditions
Interventions
None listed
Sponsors
Saga university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. patients with COPD over 40 years of age. 2. male and female 3. smoking history 4. FEV1 less than 0.7 after bronchodilator administration. 5. No history of COPD exacerbation requiring hospitalization in the past 12 months. 6. has received COPD treatment with inhaled long-acting anticholinergics (LAMA), inhaled long-acting beta2-stimulants (LABA), inhaled steroids (ICS), xanthine, expectorants, or other medications.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Patients who have undergone inpatient or outpatient induction or maintenance respiratory rehabilitation in the past 12 months. 2. Women of childbearing potential, pregnant or lactating during the study period, or planning to become pregnant. 3. Patients who are unable to undergo pulmonary function tests. 4. Patients who have experienced an acute respiratory infection (e.g., pneumonia) or moderate/severe COPD exacerbation within 4 weeks prior to screening 5. Patients with other serious comorbidities. 6. patients with malignant tumors requiring treatment. 7. Patients with other chronic respiratory diseases (bronchiectasis, interstitial pneumonia or pneumoconiosis). 8. Patients who have been identified as inappropriate subjects for this study (e.g., dementia, psychiatric disorders, cerebrovascular disease with paralysis, etc.). Consent will be obtained based on the patient's own consent, and consent by other guardians or proxies will not be accepted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between the amount of change in body composition (upper limb muscle mass, lower limb muscle mass, trunk muscle mass, and phase angle) and the diversity of the gut microbiota between baseline and 12 weeks later | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Baseline and 12-week change in the following Percentage of achievement of individually defined target number of steps per day after 12 weeks Change in 6-minute walk distance(6MWD) Percentage of patients achieving a minimum clinical effective improvement of 30 m in 6-minute walk distance(6MWD). Change in number of steps per day Change in physical activity (1.0-1.5 METs, 2.0 METs or more, 3.0 METs or more activity time) Change in body composition (upper limb muscle mass, lower limb muscle mass, trunk muscle mass, phase angle) Changes in myokines (IL-6, myostatin, BDNF, irisin) Changes in blood short-chain fatty acids Changes in diversity of intestinal microflora (Chao 1 index, Shannon index, Simpson index) and bacterial species (2) Examination of factors related to the following items, relationships among items, and relationships with other factors when divided into two counties by median values Whether or not the goal of the number of daily walks was achieved. Change in the number of daily walks Change in physical activity (1.0-1.5 METs, 2.0 METs or more, 3.0 METs or more activity time) Changes in body composition (upper limb muscle mass, lower limb muscle mass, trunk muscle mass, phase angle) Changes in myokines (IL-6, myostatin, BDNF, irisin) Changes in blood short-chain fatty acids Changes in diversity of intestinal microflora (Chao 1 index, Shannon index, Simpson index) Changes in species of intestinal microflora | — |
Countries
Japan
Contacts
Public ContactClinical research center Saga university hospital
Saga university hospital Clinical research center
Outcome results
None listed