Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Pulmonary Disease, Chronic Obstructive, Adult, therapeutic use, Humans, Treatment Outcome, daoyin therapy
Brief summary
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.
Detailed description
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).
Interventions
OTHERPulmonary daoyin therapy of China
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.
OTHERusual care
The control group will get the usual care with some additional tests for the study.
Sponsors
Henan University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* A confirmed diagnosis of moderate to very severe COPD. * Age between 40 and 80 years. * Without participation in other interventional trials in the previous one month. * With the informed consent signed.
Exclusion criteria
* Patients with poor mobility that can not do the exercise, i.e. wheelchair bound. * Pregnant or breast-feeding women. * Resting pulmonary artery pressure \> 45mmHg. * Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study. * Patients with severe comorbidities, including acute myocardial infarction and unstable angina pectoris. * Patients with post exercise syncope and osteoarthrosis that affect movement. * Complicated with severe heart failure (class II to IV NYHA heart function). * Complicated with bronchial asthma, bronchiectasis or active tuberculosis; * Complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis， * Complicated with pneumothorax, pleural effusion or pulmonary embolism. * Complicated with neuromuscular disorder which affects the respiration. * Complicated with tumors . * Complicated with serious hepatic and renal diseases. * Long periods of bed rest . * Participating in other trials or allergic to the used medicine.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Change from Baseline in CAT and SF-36 at month 3 of the treatment phase | using COPD Assessment Test (CAT) and short-form 36-item questionnaire (SF-36). |
Contacts
Primary ContactYu xueqing, doctor
Outcome results
None listed