Back to resultsDoes Pulmonary Daoyin of China Give Additional Benefit Over Usual Therapy in Management of Stable Chronic Obstructive Pulmonary Disease?
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pulmonary daoyin therapy of China
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Adult, therapeutic use, Humans, Treatment Outcome, daoyin therapy
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pulmonary daoyin therapy of China
Control
Arm 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.
The control group will get the usual care with some additional tests for the study.
Outcomes
Primary Outcome Measures
6 Minutes Walking Distance Test ( 6MWD)
Forced expiratory volume in one second, FEV1
Secondary Outcome Measures
Modified Medical Research Council (MMRC) scale
Quality of life
using COPD Assessment Test (CAT) and short-form 36-item questionnaire (SF-36).
Full Information
NCT ID
NCT01482000
First Posted
November 18, 2011
Last Updated
November 29, 2011
Sponsor
Henan University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01482000
Brief Title
Does Pulmonary Daoyin of China Give Additional Benefit Over Usual Therapy in Management of Stable Chronic Obstructive Pulmonary Disease?
Official Title
Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan University of Traditional Chinese Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Disease, Chronic Obstructive, Adult, therapeutic use, Humans, Treatment Outcome, daoyin therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
464 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary daoyin therapy of China
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will get the usual care with some additional tests for the study.
Intervention Type
Other
Intervention Name(s)
Pulmonary daoyin therapy of China
Intervention 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.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
The control group will get the usual care with some additional tests for the study.
Primary Outcome Measure Information:
Title
6 Minutes Walking Distance Test ( 6MWD)
Time Frame
Change from Baseline in 6MWD at month 3 of the treatment phase
Title
Forced expiratory volume in one second, FEV1
Time Frame
Change from Baseline in FEV1 at month 3 of the treatment phase
Secondary Outcome Measure Information:
Title
Modified Medical Research Council (MMRC) scale
Time Frame
Change from Baseline in MMRC at month 1, 2 and 3 months of the treatment phase
Title
Quality of life
Description
using COPD Assessment Test (CAT) and short-form 36-item questionnaire (SF-36).
Time Frame
Change from Baseline in CAT and SF-36 at month 3 of the treatment phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu xueqing, doctor
Phone
+86 371 66248624
Email
yxqshi@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li jiansheng, doctor
Organizational Affiliation
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
23506695
Citation
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.
Results Reference
derived
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Does Pulmonary Daoyin of China Give Additional Benefit Over Usual Therapy in Management of Stable Chronic Obstructive Pulmonary Disease?
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