TCM Daoyin Therapy in Individuals At-risk for COPD

Shanghai University of Traditional Chinese Medicine

Status: Active, not recruiting

Conditions: Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Health education; Behavioral: TCM Daoyin

Study type: Interventional

Funder types: Other

Identifiers

NCT05940480

ZY(2021-2023)- 0105-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

TCM Daoyin intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: TCM Daoyin

Behavioral: Health education

Health education control group

Active Comparator group

Description:

Participants randomized to the health education control group only receive health education and no additional training program.

Treatment:

Behavioral: Health education