TCM Daoyin Therapy in Early Chronic Obstructive Pulmonary Disease: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Lung function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessors were blinded to the group allocation of the participants.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
TCM Daoyin intervention group
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.
干预措施: TCM Daoyin (Behavioral)
TCM Daoyin intervention group
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.
干预措施: Health education (Behavioral)
Health education control group
Participants randomized to the health education control group only receive health education and no additional training program.
干预措施: Health education (Behavioral)
结局指标
主要结局
Lung function
时间窗: 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.
次要结局
- Depression, Anxiety and Stress Scale-21 item (DASS-21)(Change from Baseline DASS-21 at 16 weeks)
- 6-min walk distance(6MWD)(Change from Baseline 6MWD at 16 weeks)
- Immune function(Change from Baseline immune function at 16 weeks)
- St. George's Respiratory Questionnaire (SGRQ)(Change from Baseline SGRQ at 16 weeks)
- Adverse effects(16 weeks)
- Adverse effects(8 weeks)
研究者
Lu Ying, MM
assistant researcher
Shanghai University of Traditional Chinese Medicine