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

NCT01482000 | Unknown Phase 3 DMC

• 1 other identifier: Daoyin therapy for COPD
• Study Type: interventional
• Target: 464
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Pulmonary daoyin therapy of China

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Other: usual care

Interventions

Pulmonary daoyin therapy of China 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.

Pulmonary daoyin therapy of China

usual care OTHER

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

Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Related Publications (1)

• 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.

  PMID: 23506695 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li jiansheng, doctor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Yu xueqing, doctor

CONTACT

+86 371 66248624; yxqshi@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: November 30, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 30, 2011

Record last verified: 2011-10