TCM Daoyin Therapy in Individuals At-risk for COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05940480
• Other study ID #: ZY(2021-2023)- 0105-08
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Ying Lu, Master
• Phone: 86(021)54240423
• Email: luwing_happy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• TCM Daoyin
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 education
Health education is provided by doctor and nurse, including work, rest, diet and other basic programs.

Locations

Country	Name	City	State
China	Changzheng Community Health Service Center of Putuo District, Shanghai	Shanghai	Shanghai
China	Shanghai Qigong Research Institute	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Changzheng Community Health Service Center of Putuo District, Shanghai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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