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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
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Chronic Obstructive Pulmonary Disease (COPD) is a disease with a very high morbidity and mortality rate. When the lung function drops lower and lower, patients will bear great affliction physically and mentally. How to improve the quality of life in patients with COPD is a hot topic in the study of COPD now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for COPD patients.
To investigate the efficacy of Baduanjin exercise for patients with stable chronic obstructive pulmonary disease on phase II~III. A prospective, randomized, controlled clinical trial was designed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baduanjin exercise group | Experimental | Participants in this group received Baduanjin exercise |
|
| Instrument rehabilitation group | Active Comparator | Participants in this group received rehabilitation by using tri-ball respiratory trainer |
|
| Baduanjin Exercise and Instrument Rehabilitation | Active Comparator | Participants in this group received both instrument rehabilitation and Baduanjin exercise |
|
| No Intervention | No Intervention | Participants in this group only received routine drug-treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baduanjin exercise | Behavioral | Participants received Baduanjin exercise. Each Baduanjin exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| St. George's respiratory questionnaire (SGRQ) | Evaluating the changes of impact on quality of life | Baseline, 3 months, 6 months |
| Six-minute walk test (6MWT) | Testing patients changes on walking distance and accompanies symptoms in 6 minutes | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmanory function indicators (FEV1/FVC, FEV1pred%) | Assessing changes of airway limitation | Baseline, 3 months, 6 months |
| Modified British medical research council questionnaire (mMRC) | Evaluating the severity of dyspnea, totally has 5 grade from 0-4, the higher grade represent a severer symptom |
| Measure | Description | Time Frame |
|---|---|---|
| The main TCM symptoms | The changes of scores of TCM syndromes, the total score ranges from 0-15, the higher score represent a worse outcome | Baseline, 1 month, 2 months, 3 months, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Sun, Master | Contact | 86-21-20256375 | gulik002@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhang, Master | Shanghai Shuguang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Shuguang Hospital | Shanghai | 201203 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Instrument rehabilitation | Device | Participants received pulmanory rehabilitation by using tri-ball respiratory trainer. Each instrument exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks |
|
| Baseline, 1 month, 2 months, 3 months, 6 months |
| COPD assessment test (CAT) | Assessing the quality of life, the total score ranges from 0-40, the higher score represent a worse outcome | Baseline, 1 month, 2 months, 3 months, 6 months |
| Times of acute exacerbation | Recording the frequency of acute exacerbation | Baseline, 1 month, 2 months, 3 months, 6 months |
| Self-rating anxiety scale (SAS) | Evaluating the stage of anxiety, the total score ranges from 20-80, the higher score represent a worse outcome | Baseline, 3 months, 6 months |
| Self-rating depression scale (SDS) | Evaluating the stage of depression, the total score ranges from 20-80, the higher score represent a worse outcome | Baseline, 3 months, 6 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |