Rehabilitation Intervention for COPD Combined With Cardiovascular and Cerebrovascular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50,000
- 试验地点
- 1
- 主要终点
- The proportion of high-risk and diagnosed individuals with COPD
研究概览
简要总结
Firstly, to screen out the high-risk population of COPD combined with cardiovascular and cerebrovascular diseases, COPD with cardiovascular and make a diagnosis. Then, to evaluate the therapeutic effect of Pulmonary rehabilitation exercise and usual care for three months. And finally, to build a trinity model of rehabilitation management of COPD patients. The objective of this project is to establish and promote the application of diagnostic and treatment norms.
详细描述
Firstly, to screen out the high-risk population of COPD combined with cardiovascular and cerebrovascular diseases, COPD with cardiovascular and make a diagnosis. Then, participants were randomized (1:1) to either the optimized or routine group via a computer-generated random number table. The Routine Care Group received treatment for three months and follow-up with medications prescribed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 Report. The Pulmonary Rehabilitation Care Group received the Pulmonary rehabilitation exercise and usual care for three months. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person)，CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function of the two groups of patients one year after the intervention. And finally, to build a trinity model of rehabilitation management of COPD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Committed to adhering to the study protocol and cooperating with the implementation of the entire research process.
- •Aged 18 years or older, regardless of gender.
- •Signed informed consent form.
排除标准
- •Individuals with severe mental illness.
- •Individuals assessed by medical personnel as having a disease that requires immediate hospitalization or a severe, uncontrollable condition that is life-threatening in the short term.
- •Women who are pregnant, breastfeeding, or using inappropriate contraception methods.
- •Individuals who refuse to cooperate with follow-up questionnaires or specimen collection.
- •Patients currently participating in other interventional clinical drug trials.
研究组 & 干预措施
COPD Pulmonary Rehabilitation Care Group
The Pulmonary Rehabilitation Care Group received the Pulmonary rehabilitation exercise and usual care for three months. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person)，CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function one year after the intervention.
干预措施: Pulmonary Rehabilitation Care Group (Combination Product)
COPD Routine Care and Sham Comparator Group
The Routine Care Group received treatment for three months and follow-up with medications prescribed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 Report. Next, Observe the changes in the improvement of acute exacerbation frequency (times/year/person)，CAT Scoring and St. George's Respiratory Questionnaire (SGRQ), as well as lung ventilation and diffusion function of the two groups of patients one year after the intervention.
干预措施: The Routine Care (Non-Pharmacological and Pharmacological Treatments ) Group (Other)
结局指标
主要结局
The proportion of high-risk and diagnosed individuals with COPD
时间窗: through study completion, an average of 4 year
We conducted a cross-sectional screening among a total of 50,000 people, and then calculated the proportion of the high-risk and confirmed COPD patients among the total population. We use COPD questionnaire to screen COPD high-risk groups and make a diagnosis of COPD through pulmonary function test.
the improvement of acute exacerbation frequency (times/year/person)
时间窗: through study completion, an average of 4 year
Observe the changes in the improvement of acute exacerbation frequency (times/year/person) after intervention
次要结局
- Blood pressure(through study completion, an average of 4 year)
- blood lipids(through study completion, an average of 4 year)
- FBG(fasting blood-glucose)(through study completion, an average of 4 year)
研究者
Yang Jin
Subdecanal,Professor and Director of Respiratory and Critical Care Medicine, Chief Investigator
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology