An interventional study of TCM Daoyin and Health education in Chronic Obstructive Pulmonary Disease and Lung Diseases, Obstructive, sponsored by Shanghai University of Traditional Chinese Medicine. Active, not recruiting at 2 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Shanghai University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 99 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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 · Behavioral: Health education
Participants randomized to the health education control group only receive health education and no additional training program.
Behavioral: Health education
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.
Also known as: Qigong
Health education is provided by doctor and nurse, including work, rest, diet and other basic programs.
Lung function
Participants' lung function (FVC、FVC%、FEV1、FEV1%、FEV1/FVC) will be tested to identify air flow condition in both group.
Time frame: Change from Baseline lung function at 16 weeks
6-min walk distance(6MWD)
The 6MWD is a well-established field exercise test to assess the functional exercise capacity in COPD clinical trials.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Shanghai University of Traditional Chinese Medicine