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| Name | Class |
|---|---|
| Changzheng Community Health Service Center of Putuo District, Shanghai | UNKNOWN |
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Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease. The aim of prospective randomized study is to evaluate the effects of TCM Daoyin training on Individuals at-risk for COPD.
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. Early prevention and treatment of COPD is crucial, but there is a lack of specific interventions for individuals at-risk for COPD in clinical guidelines. The study focuses on individuals at-risk for COPD (COPD-SQ≥16, current lung function failed to meet diagnostic criteria for COPD but with manifestations of early airflow limitation).
This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 60 participants (30 for TCM Daoyin intervention group receiving health education plus a TCM Daoyin training program, and 30 for health education control group only receiving health education).
TCM Daoyin is a form of mind-body exercise with a profound philosophical foundation rooted in Chinese culture. Previous researches have provided some evidence of beneficial effects on TCM Daoyin for COPD patients with an established diagnosis, such as Liuzijue and Baduanjin. However, the evidences of TCM Daoyin on patients with early COPD is limited. The aim of prospective randomized study is to evaluate the effects of TCM Daoyin training on individuals at-risk of COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM Daoyin intervention group | Experimental | Participants randomized to TCM Daoyin intervention group receive health education plus a TCM Daoyin training program. The TCM Daoyin training program was a 16-week, instructor-led group training program. |
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| Health education control group | Active Comparator | Participants randomized to the health education control group only receive health education and no additional training program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCM Daoyin | Behavioral | The TCM Daoyin training program consisted of two 90-min training classes and at least five 30-min at-home practice sessions per week for 16-weeks. All sessions included 10 min of warmup and 10 min of cooldown. |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function | Participants' lung function (FVC、FVC%、FEV1、FEV1%、FEV1/FVC) will be tested to identify air flow condition in both group. | Change from Baseline lung function at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 6-min walk distance(6MWD) | The 6MWD is a well-established field exercise test to assess the functional exercise capacity in COPD clinical trials. | Change from Baseline 6MWD at 16 weeks |
| Immune function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoting Zhao | Shanghai Qigong Research Institute | Study Chair |
| Jie Li, Doctor | Shanghai University of Traditional Chinese Medicine | Study Director |
| Ying Lu, Master | Shanghai Qigong Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Qigong Research Institute | Shanghai | Shanghai Municipality | 021 | China | ||
| Changzheng Community Health Service Center of Putuo District, Shanghai |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D064906 | Qigong |
| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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This study is a 16-week, randomized controlled trial. Individuals at-risk for COPD are randomized to either TCM Daoyin intervention group or health education control group.
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The outcome assessors were blinded to the group allocation of the participants.
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| Health education | Behavioral | Health education is provided by doctor and nurse, including work, rest, diet and other basic programs. |
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Venous blood will be collect to detect immunity function (IL-6, IL-8, IL-10 and biomarkers).
| Change from Baseline immune function at 16 weeks |
| Depression, Anxiety and Stress Scale-21 item (DASS-21) | Questions focus on depressive, anxious and stress symptoms during the past 7 days, and higher cumulative scores indicate more severe depression, anxiety and stress. Subscale scores are calculated as the sum of the responses to the seven items from each subscale multiplied by 2. The cutoffs for depression, anxiety, and stress are >9, >7, and >14, respectively. | Change from Baseline DASS-21 at 16 weeks |
| St. George's Respiratory Questionnaire (SGRQ) | Quality of Life will be assessed by St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a disease-specific measure of health status for use in COPD. It has a 0 - 100 score; 0 as low symptoms (feeling better) and 100 as high symptoms (feeling worse). A 4-unit change is the minimum clinically important difference. | Change from Baseline SGRQ at 16 weeks |
| Adverse effects | During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred. | 8 weeks |
| Adverse effects | During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred. | 16 weeks |
| Shanghai |
| Shanghai Municipality |
| 200333 |
| China |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |