Clinical trial NCT01482000: Does Pulmonary Daoyin of China Give Additional Benefit Over Usual Therapy in Management of Stable Chronic Obstructive Pulmonary Disease?
Official title: Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Adult
therapeutic use
Humans
Treatment Outcome
daoyin therapy
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 464
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 6 Minutes Walking Distance Test ( 6MWD)
timeFrame: Change from Baseline in 6MWD at month 3 of the treatment phase
measure: Forced expiratory volume in one second, FEV1
timeFrame: Change from Baseline in FEV1 at month 3 of the treatment phase
Secondary outcomes:
measure: Modified Medical Research Council (MMRC) scale
timeFrame: Change from Baseline in MMRC at month 1, 2 and 3 months of the treatment phase
measure: Quality of life
timeFrame: Change from Baseline in CAT and SF-36 at month 3 of the treatment phase
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Li jiansheng, doctor
role: STUDY_CHAIR
References:
citation: 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.