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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
464
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.
The control group will get the usual care with some additional tests for the study.
6 Minutes Walking Distance Test ( 6MWD)
Time frame: Change from Baseline in 6MWD at month 3 of the treatment phase
Forced expiratory volume in one second, FEV1
Time frame: Change from Baseline in FEV1 at month 3 of the treatment phase
Modified Medical Research Council (MMRC) scale
Time frame: 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).
Time frame: Change from Baseline in CAT and SF-36 at month 3 of the treatment phase
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