TCM Daoyin Therapy in Individuals At-risk for COPD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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TCM Daoyin Therapy in Early Chronic Obstructive Pulmonary Disease: A Pilot Study

Conditions
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Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive

Intervention / Treatment
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* Behavioral: TCM Daoyin
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject at-risk for COPD (Chronic obstructive pulmonary disease screening questionnaire (COPD-SQ) score≥16; and pre-bronchodilator FEV1/FVC ≥ 0.70, or pre-bronchodilator FEV1/FVC<0.70 but post-bronchodilator FEV1/FVC ≥ 0.70). Aged 40 to 75, male or female. Subject has a clear mind and the ability to lead an independent life. Subject agrees to perform a blood-test. Subject agrees to participate in this study and sign to the informed consent. Exclusion Criteria: Subject with acute exacerbation of COPD. Subject with respiratory infectious disease (e.g., tuberculosis, influenza, etc.) within 1 month. Subject with serious current unstable physical illness and mental illness. Subject with definite clinical diagnosis of Alzheimer's disease, or severe cognitive impairment. Subject is pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM Daoyin intervention group<br>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. | Behavioral: TCM Daoyin<br>* 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.<br>* Other names: Qigong;Behavioral: Health education<br>* Health education is provided by doctor and nurse, including work, rest, diet and other basic programs.<br>|
| Active Comparator: Health education control group<br>Participants randomized to the health education control group only receive health education and no additional training program. | Behavioral: Health education<br>* Health education is provided by doctor and nurse, including work, rest, diet and other basic programs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TCM Daoyin, at-risk for COPD, early COPD, chronic obstructive pulmonary disease