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

Henan University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: usual care; Other: Pulmonary daoyin therapy of China

Study type: Interventional

Funder types: Other

Identifiers

NCT01482000

Daoyin therapy for COPD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 464 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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464 participants in 2 patient groups

Pulmonary daoyin therapy of China

Experimental group

Description:

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.

Treatment:

Other: Pulmonary daoyin therapy of China

Control

Active Comparator group

Description:

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

Treatment:

Other: usual care