Chronic Obstructive Pulmonary DiseaseNCT05940480
TCM Daoyin Therapy in Individuals At-risk for COPD
A study testing TCM Daoyin and Health education in people with Chronic Obstructive Pulmonary Disease and Lung Diseases, Obstructive, run by Shanghai University of Traditional Chinese Medicine at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
- What is being tested?
- TCM Daoyin and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jan 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Qigong Research Institute
Shanghai, Shanghai Municipality, 021
Changzheng Community Health Service Center of Putuo District, Shanghai
Shanghai, Shanghai Municipality, 200333
About this study
Official title: TCM Daoyin Therapy in Early Chronic Obstructive Pulmonary Disease: A Pilot Study
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.
Read the detailed description
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.
- Being tested
- TCM Daoyin, Health education
- Keywords
- TCM Daoyin, at-risk for COPD, early COPD, chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM DaoyinBehavioural
Also called Qigong
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.
Health educationBehavioural
Health education is provided by doctor and nurse, including work, rest, diet and other basic programs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: TCM Daoyin; Behavioral: Health education |
| Health education control group | Active comparator | Participants randomized to the health education control group only receive health education and no additional training program. Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Participants' lung function (FVC、FVC%、FEV1、FEV1%、FEV1/FVC) will be tested to identify air flow condition in both group.
Measured: Change from Baseline lung function at 16 weeks
Secondary outcomes (6)
6-min walk distance(6MWD)
The 6MWD is a well-established field exercise test to assess the functional exercise capacity in COPD clinical trials.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start3 Jan 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Changzheng Community Health Service Center of Putuo District, Shanghai
- Responsible party
- Principal investigator, Lu Ying, MM, Shanghai University of Traditional Chinese Medicine
- Investigators
- Xiaoting Zhao, Study chair, Shanghai Qigong Research InstituteJie Li, Doctor, Study director, Shanghai University of Traditional Chinese MedicineYing Lu, Master, Principal investigator, Shanghai Qigong Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940480
- Sponsor's protocol ID
- ZY(2021-2023)- 0105-08
- Status last verified
- Apr 2026
- First submitted
- 4 Jul 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCM Daoyin Therapy in Early Chronic Obstructive Pulmonary Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT05940480
- Acronym / sponsor ID
- ZY(2021-2023)- 0105-08
- Keywords
- TCM Daoyin, at-risk for COPD, early COPD, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Changzheng Community Health Service Center of Putuo District, Shanghai
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TCM Daoyin intervention group | Experimental | Behavioral: TCM Daoyin, Behavioral: Health educationParticipants 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. |
| Health education control group | Active comparator | Behavioral: Health educationParticipants randomized to the health education control group only receive health education and no additional training program. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCM DaoyinAlso: QigongThe 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. | Behavioural | TCM Daoyin intervention group |
| Health educationHealth education is provided by doctor and nurse, including work, rest, diet and other basic programs. | Behavioural | Health education control group, TCM Daoyin intervention group |
Primary outcome
Lung function
Time frame: Change from Baseline lung function at 16 weeks
Participants' lung function (FVC、FVC%、FEV1、FEV1%、FEV1/FVC) will be tested to identify air flow condition in both group.
6 secondary outcomes
6-min walk distance(6MWD)
Time frame: Change from Baseline 6MWD at 16 weeks
Immune function
Time frame: Change from Baseline immune function at 16 weeks
Depression, Anxiety and Stress Scale-21 item (DASS-21)
Time frame: Change from Baseline DASS-21 at 16 weeks
St. George's Respiratory Questionnaire (SGRQ)
Time frame: Change from Baseline SGRQ at 16 weeks
Adverse effects
Time frame: 8 weeks
Adverse effects
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoting Zhao study chair
Shanghai Qigong Research Institute
Jie Li, Doctor study director
Shanghai University of Traditional Chinese Medicine
Ying Lu, Master principal investigator
Shanghai Qigong Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCM Daoyin and Health education in people with Chronic Obstructive Pulmonary Disease and Lung Diseases, Obstructive, run by Shanghai University of Traditional Chinese Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: Change from Baseline lung function at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.