Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the exercise capacity and pulmonary function test parameters of Chronic Obstructive Pulmonary Disease (COPD) patients who underwent usual care with and without pulmonary daoyin therapy of China in community.
This is a multicenter, randomized, none-blind, controlled study to evaluate the effect of pulmonary daoyin therapy in moderate to very severe COPD subjects. Following a 14 day run-in period, approximately 464 subjects will be randomly assigned to none-blind treatment for 3 months. The primary measure of efficacy is the Exercise Capacity (6MWD) and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life (CAT,SF-36), frequency of exacerbations. Safety will be assessed through the collection of adverse events. There will be a total of 4 study visits (randomization, and after 1,2,3 months of treatment).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary daoyin therapy of China | Experimental | The intervention group will perform a 3 months pulmonary daoyin of China therapy program which consists of training and patient education. They will be evaluated with some tests for the study. |
|
| Control | Active Comparator | The control group will get the usual care with some additional tests for the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary daoyin therapy of China | Other | The intervention group will perform a 3 months pulmonary daoyin of China therapy program which consists of training and patient education. They will be evaluated with some tests for the study. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minutes Walking Distance Test ( 6MWD) | Change from Baseline in 6MWD at month 3 of the treatment phase | |
| Forced expiratory volume in one second, FEV1 | Change from Baseline in FEV1 at month 3 of the treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Medical Research Council (MMRC) scale | Change from Baseline in MMRC at month 1, 2 and 3 months of the treatment phase | |
| Quality of life | using COPD Assessment Test (CAT) and short-form 36-item questionnaire (SF-36). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu xueqing, doctor | Contact | +86 371 66248624 | yxqshi@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li jiansheng, doctor | The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23506695 | Derived | Yu XQ, Li JS, Li SY, Xie Y, Wang MH, Zhang HL, Wang HF, Wang ZW. Functional and psychosocial effects of pulmonary Daoyin on patients with COPD in China: study protocol of a multicenter randomized controlled trial. J Integr Med. 2013 Mar;11(2):140-6. doi: 10.3736/jintegrmed2013015. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| usual care | Other | The control group will get the usual care with some additional tests for the study. |
|
| Change from Baseline in CAT and SF-36 at month 3 of the treatment phase |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided