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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Pulmonary daoyin therapy of China; Other: usual care

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 Type: Interventional
• Enrollment (Anticipated): 464
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Investigators: Study Chair: Li jiansheng, doctor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: November 18, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): November 30, 2011

Study Record Updates

• Last Update Posted (Estimate): November 30, 2011
• Last Update Submitted That Met QC Criteria: November 29, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Humans; Adult; Pulmonary Disease, Chronic Obstructive; Treatment Outcome; therapeutic use; daoyin therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease
• Other Study ID Numbers: Daoyin therapy for COPD