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

Sponsor

Henan University of Traditional Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT01482000

Collaborator

(none)

464

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Other: Pulmonary daoyin therapy of China Other: usual care	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

464 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.
Active Comparator: Control The control group will get the usual care with some additional tests for the study.	Other: usual care The control group will get the usual care with some additional tests for the study.

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

Active Comparator: Control

The control group will get the usual care with some additional tests for the study.

Other: usual care

The control group will get the usual care with some additional tests for the study.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.