Does Pulmonary Daoyin of China Give Additional Benefit Over Usual Therapy in Management of Stable Chronic Obstructive Pulmonary Disease?
This study is not yet open for participant recruitment.
Verified October 2011 by Henan University of Traditional Chinese Medicine
Sponsor:
Henan University of Traditional Chinese Medicine
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
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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
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013