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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01482000
• Other study ID #: Daoyin therapy for COPD
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 18, 2011
• Last updated: November 29, 2011
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: October 2011
• Source: Henan University of Traditional Chinese Medicine
• Contact: Yu xueqing, doctor
• Phone: +86 371 66248624
• Email: yxqshi[@]126.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 464
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minutes Walking Distance Test ( 6MWD)		Change from Baseline in 6MWD at month 3 of the treatment phase	No
Primary	Forced expiratory volume in one second, FEV1		Change from Baseline in FEV1 at month 3 of the treatment phase	No
Secondary	Modified Medical Research Council (MMRC) scale		Change from Baseline in MMRC at month 1, 2 and 3 months of the treatment phase	No
Secondary	Quality of life	using COPD Assessment Test (CAT) and short-form 36-item questionnaire (SF-36).	Change from Baseline in CAT and SF-36 at month 3 of the treatment phase	No