Study on the Prevention and Control System of Chronic Airway Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 522
- 主要终点
- Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months
研究概览
简要总结
In this study, patients with Chronic Obstructive Pulmonary Diseases (COPD) in stable and acute exacerbation stage were selected as the research objects, and the open, parallel and randomized controlled clinical trial design was adopted. Participants were randomly divided into trial group and control group. The control group was only given routine education, and the experimental group, on the basis of routine education, developed a respiratory rehabilitation training program lasting for 12 weeks according to the individual situation of patients. All participants were interviewed for 6 times (baseline and 4,8,12 weeks, 6 months and 12 months after admission) for a period of 1 year. Acute exacerbation, activity tolerance (6-minute walking test), living environment, clinical symptoms, lung function, airway inflammation water level index and biological samples were collected at each visit. At the same time, according to the diary filled in by the patients, the investigators can obtain the daily stay time indoors and outdoors and the longitude and latitude information of the regular stay fixed place, and geographic information system (GIS) is used to match the nearest environmental monitoring station, obtain the data of air pollutants and meteorological indicators (SO2, NO2, Co, O3, PM10, temperature and humidity, etc.), and estimate the individual exposure level of air pollutants.
详细描述
First of all, the investigators need to obtain detailed history records, including cardio pulmonary vascular history, related complications, treatment history and other high-risk factors. After careful review, the investigators need to determine whether the patient is suitable to participate in the pulmonary rehabilitation plan. The investigators need to pay special attention to diseases that may affect the patient's performance, including special cardiovascular diseases, skeletal muscle and nervous system.
Functional evaluation: pulmonary function test, exercise cardiopulmonary function evaluation (6-minute walking test), grip strength test, psychological state evaluation ( Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 9-item (phq-9)), nutrition screening and evaluation and others (general examination such as height, weight, BMI, waist and hip circumference, WHR, blood pressure, heart rate and blood biochemical examination; quality of life evaluation; other related individual evaluation Estimation includes smoking and sleep).
- Acute exacerbation:
The exercise prescription of "hospitalization + home rehabilitation" was adopted, which mainly combined aerobic endurance training, intermittent strength training and inspiratory muscle training, as follows:
Aerobic exercise: 4 times / week, 30min / time, fast walking or power cycling Strength training: unarmed or instrument, 4 times / week, 3 groups / time, 10-12 times / group Breath training: ① breath Trainer: once a day, 20-30min a time
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
- None
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
- •It meets the diagnostic criteria of global initiative for chronic obstructive pulmonary disease (gold 2017 Edition), is in a stable period of disease or meets the diagnostic criteria of guidelines for the prevention and treatment of bronchial asthma (GINA 2016 Edition)
- •Have lived in the local area for more than 2 consecutive years, and there is no plan to go out for more than half a year in succession during the survey period
- •No smoking history or no smoking for half a year or more
- •40-75 years old
排除标准
- •Patients with history of chronic diseases, such as serious cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, epilepsy and other nervous system diseases, mental diseases, psychiatric diseases, active pulmonary tuberculosis, tumor, anti tuberculosis treatment or combined influence information collection
- •Patients who have undergone thoracic, abdominal and ophthalmic operations in the past 3 months
- •Pregnant and lactating women
- •Did not sign informed consent
结局指标
主要结局
Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months
时间窗: baseline and 4, 8, 12 weeks, 6 months and 12 months
walking distance in 6-minute walking test
Times of acute exacerbation
时间窗: through study completion, an average of 1 year
times of acute exacerbation in the period of one year
次要结局
- Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation(9 months)
- Change from Baseline modified Medical Research Council dyspnea (mMRC) at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline Eosinophil Count in Sputum at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline Pulmonary Function of FVC at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline Pulmonary Function of FEV1/FVC at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline Inflammatory Factors in sputum at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline Patient Health Questionnaire 9-item (PHQ-9) at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline Pittsburgh Sleep Quality Index (PSQI) at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline COPD assessment test (CAT) at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline St George's questionnaire (SGRQ) at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline Generalized Anxiety Disorder 7-item (GAD-7) at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline Pulmonary Function of FEV1 at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
- Change from Baseline Fractional exhaled Nitric Oxide (FeNO) at 4, 8, 12 weeks, 6 months and 12 months(baseline and 4, 8, 12 weeks, 6 months and 12 months)
研究者
Hongtao Niu
Principal Investigator
China-Japan Friendship Hospital