Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Pulmonary rehabilitation outcome
研究概览
简要总结
To comprehensively evaluate the pulmonary rehabilitation (PR) outcomes of patients with chronic respiratory disease (CRD), and to screen biomarkers for predicting different PR outcomes of patients with CRD using metabolomics methods, and to build a prediction model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the Global initiative for chronic obstructive lung disease (GOLD) 2022 definition of stable COPD;
- •Age 30-75 years;
- •Lung CT images only showed chronic bronchitis and emphysema;
- •Agree to participate in the study and is able to cooperate with exhaled breath condensate collection.
- •For bronchiectasis
- •Lung CT showed bronchiectasis;
- •Age 18-75 years;
- •Spirometry suggests obstructive ventilatory dysfunction: forced expiratory volume in one second (FEV1) is less than 70% of forced vital capacity (FVC) post bronchodilator inhalation.
排除标准
- •Asthma or other respiratory diseases
- •History of pulmonary surgery
- •α1 antitrypsin deficiency
- •Autoimmune diseases
- •Patients with acute myocardial infarction, chronic heart failure, severe cerebral infarction or cerebral hemorrhage
- •A history of malignant disease now or within 2 years
- •History of acute exacerbation or change of medication in the past 4 weeks
- •A history of blood transfusion within the last 4 weeks
- •Drugs or alcohol abuse
- •Breastfeeding or pregnant women
- •Unable to cooperate with pulmonary rehabilitation for various reasons
结局指标
主要结局
Pulmonary rehabilitation outcome
时间窗: At week 12 of pulmonary rehabilitation
Systemic multidimensional measurements （SMM） will be used to evaluate the outcomes of PR program, the patients will be grouped in very good, good, moderate and poor responders by cluster analysis. SMM are as follows: changes in the degree of dyspnea will be measured using the modified Medical Research Council scale; the St George's Respiratory Questionnaire will be use to evaluate changes in health status; exercise performance will be measured by a 6-min walk test and a constant work-rate test; the Canadian Occupational Performance Measure will be used to identify specific problematic activities of daily life; patients scored how well they were performing the problematic activities of daily life and how satisfied they were with this level of performance; symptoms of anxiety and depression will be measured by Hospital Anxiety and Depression Scale. The efficacy of the PR program of the whole sample will be evaluated based on the minimal clinically importance.
次要结局
未报告次要终点