Does Pulmonary Daoyin of China Give Additional Benefit Over Usual Therapy in Management of Stable Chronic Obstructive Pulmonary Disease?

Phase 3

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Pulmonary daoyin therapy of China; Other: usual care

• Registration Number: NCT01482000
• Lead Sponsor: Henan University of Traditional Chinese Medicine

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).

Study Timeline

• Status Verified: 2011-10
• Study Start: 2011-11
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-29
• Last Update Submitted: 2011-11-29
• Study First Posted: 2011-11-30
• Last Update Posted: 2011-11-30
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 464

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary daoyin therapy of China	Pulmonary 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.
Control	usual care	The control group will get the usual care with some additional tests for the study.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).