Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Acupuncture monotherapy (12 times in 3 months) followed by combined acupuncture-PR (adding 12 sessions of acupuncture therapy to 20 sessions of pulmonary rehabilitation in 3 months)
Sponsors
National Hospital Organization Toneyama National Hospital, Division of clinical reserach,laboratory of respiratory science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)COPD determined according to diagnostic criteria and classified as stage II or more using the GOLD criteria. Those rated as grade 1 or more according to modified Medical Research Council dyspnea scale (mMRC) were included. 2)Age 40 or more years 3)Stable patients able to tolerate cardiopulmonary exercise testing to ensure adequate evaluation 4)Signed agreement to participate in the study
Exclusion criteria
Exclusion criteria: 1)Malignant tumors 2)Active infectious disease 3)Severe heart disease 4)Hepatic failure (serum aspartate aminotransferase and alanine aminotransferase levels at least twice the upper limit of normal) 5)Renal failure (serum creatinine levels 2.0 mg/dL or more) 6)Bronchial asthma 7)Drug regimen changed during clinical trials 8)Participation in pulmonary rehabilitation programs 9)Judged inadequate to participate in the study by their physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As outcomes of acupuncture monotherapy: endurance time, peak oxygen uptake (peak VO2). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) As outcomes of acupuncture monotherapy: Borg scale, O2-pulse, VD/VT,VE/VO2, VE/VCO2, delta Fo2, all of which will be measured using cardiopulmonary exercise testing (CPET). 2) As outcomes of i) combined acupuncture-PR alone, and of ii) adding combined acupuncture-PR to acupuncture monotherapy (i.e., overall treatment), peak VO2, endurance time, Borg scale, O2-pulse, VD/VT, VE/VO2, VE/VCO2, delta FO2, all of which will be measured using CPET. 3) As outcomes of i) acupuncture monotherapy alone, ii) combined acupuncture-PR alone, and iii) adding combined acupuncture-PR to acupuncture monotherapy (i.e., overall treatment), a) respiratory muscle strength, b) body weight, c) CAT score, d) SGRQ, e) mMRC dyspnea scale, f) pulmonary function test (including MostGraph and expiratory fractional exhaled nitric oxide), g) daily physical activities measured using Activision markers, h) skeletal muscle mass, bone mass, and fat measured using dual-energy X-ray absorptiometry (DEXA), i) blood examination (norepinephrine, VEGF, ghrelin, hANP), and j) iliopsoas muscle (volume, CT number) | — |
Countries
Japan
Contacts
Public ContactKeisuke Miki
National Hospital Organization Toneyama National Hospital Laboratory chief, Division of clinical reserach, laboratory of respiratory science
Outcome results
None listed