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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Henan University of Traditional Chinese Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01482000
First received: November 18, 2011
Last updated: November 29, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Other: Pulmonary daoyin therapy of China
Other: usual care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application

Resource links provided by NLM:


Further study details as provided by Henan University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • 6 Minutes Walking Distance Test ( 6MWD) [ Time Frame: Change from Baseline in 6MWD at month 3 of the treatment phase ] [ Designated as safety issue: No ]
  • Forced expiratory volume in one second, FEV1 [ Time Frame: Change from Baseline in FEV1 at month 3 of the treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Medical Research Council (MMRC) scale [ Time Frame: Change from Baseline in MMRC at month 1, 2 and 3 months of the treatment phase ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Change from Baseline in CAT and SF-36 at month 3 of the treatment phase ] [ Designated as safety issue: No ]
    using COPD Assessment Test (CAT) and short-form 36-item questionnaire (SF-36).


Estimated Enrollment: 464
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Pulmonary daoyin therapy of china
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.
Other Name: 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).

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482000

Contacts
Contact: Yu xueqing, doctor +86 371 66248624 yxqshi@126.com

Sponsors and Collaborators
Henan University of Traditional Chinese Medicine
Investigators
Study Chair: Li jiansheng, doctor The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01482000     History of Changes
Other Study ID Numbers: Daoyin therapy for COPD
Study First Received: November 18, 2011
Last Updated: November 29, 2011
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Henan University of Traditional Chinese Medicine:
Pulmonary Disease, Chronic Obstructive
Adult
therapeutic use
Humans
Treatment Outcome
daoyin therapy

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014