Clinical trial NCT05940480: TCM Daoyin Therapy in Individuals At-risk for COPD
Official title: TCM Daoyin Therapy in Early Chronic Obstructive Pulmonary Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lung Diseases, Obstructive
Keywords: TCM Daoyin
at-risk for COPD
early COPD
chronic obstructive pulmonary disease
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Changzheng Community Health Service Center of Putuo District, Shanghai
First posted: 2023-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lung function
timeFrame: Change from Baseline lung function at 16 weeks
Secondary outcomes:
measure: 6-min walk distance(6MWD)
timeFrame: Change from Baseline 6MWD at 16 weeks
measure: Immune function
timeFrame: Change from Baseline immune function at 16 weeks
measure: Depression, Anxiety and Stress Scale-21 item (DASS-21)
timeFrame: Change from Baseline DASS-21 at 16 weeks
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Change from Baseline SGRQ at 16 weeks
measure: Adverse effects
timeFrame: 8 weeks
measure: Adverse effects
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Qigong Research Institute
state: Shanghai
city: Shanghai
country: China
facility: Changzheng Community Health Service Center of Putuo District, Shanghai
state: Shanghai
Study officials:
affiliation: Shanghai Qigong Research Institute
name: Xiaoting Zhao
role: STUDY_CHAIR
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jie Li, Doctor
role: STUDY_DIRECTOR
affiliation: Shanghai Qigong Research Institute
name: Ying Lu, Master
role: PRINCIPAL_INVESTIGATOR
References: