TCM Daoyin Therapy in Individuals At-risk for COPD

Not Applicable

Active, not recruiting

• Conditions: Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: TCM Daoyin; Behavioral: Health education

• Registration Number: NCT05940480
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief 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.

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 Timeline

• Study Start: 2023-01-03
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-29
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM Daoyin intervention group	TCM Daoyin	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.
TCM Daoyin intervention group	Health education	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.
Health education control group	Health education	Participants randomized to the health education control group only receive health education and no additional training program.

Primary Outcome Measures

Name	Time	Method
Lung function	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.

Secondary Outcome Measures

Name	Time	Method
Depression, Anxiety and Stress Scale-21 item (DASS-21)	Change from Baseline DASS-21 at 16 weeks	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.
6-min walk distance(6MWD)	Change from Baseline 6MWD at 16 weeks	The 6MWD is a well-established field exercise test to assess the functional exercise capacity in COPD clinical trials.
Immune function	Change from Baseline immune function at 16 weeks	Venous blood will be collect to detect immunity function (IL-6, IL-8, IL-10 and biomarkers).
St. George's Respiratory Questionnaire (SGRQ)	Change from Baseline SGRQ at 16 weeks	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.
Adverse effects	16 weeks	During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred.

Trial Locations

Locations (2)

Shanghai Qigong Research Institute; 🇨🇳 Shanghai, Shanghai, China

Changzheng Community Health Service Center of Putuo District, Shanghai; 🇨🇳 Shanghai, Shanghai, China