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

NCT ID: NCT01482000

Last Updated: 2011-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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).

Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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Pulmonary Disease, Chronic Obstructive Adult therapeutic use Humans Treatment Outcome daoyin therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pulmonary daoyin therapy of China

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

usual care

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li jiansheng, doctor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Central Contacts

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Yu xueqing, doctor

Role: CONTACT

Phone: +86 371 66248624

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 23506695 (View on PubMed)

Other Identifiers

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Daoyin therapy for COPD

Identifier Type: -

Identifier Source: org_study_id