Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study

Study Overview
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Brief Summary
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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.

Official Title
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Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study

Conditions
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Chronic Obstructive Pulmonary Disease, Bronchiectasis

Intervention / Treatment
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* Other: metabonomics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For COPD 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD and bronchiectasis patients with some metabolic profiling<br>The patients with stable COPD and bronchiectasis who meet the screening criteria and with some metabolic profiling according to the previous studies. | Other: metabonomics<br>* profiles of metabolites in serum and exhale breath condensate (EBC) at baseline and after pulmonary rehabilitation<br>|
| COPD and bronchiectasis patients without the metabolic profiling<br>The patients with stable COPD and bronchiectasis who meet the screening criteria and without the metabolic profiling according to the previous studies. | Other: metabonomics<br>* profiles of metabolites in serum and exhale breath condensate (EBC) at baseline and after pulmonary rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary rehabilitation outcome | 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. | At week 12 of pulmonary rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary rehabilitation, chronic respiratory disease, metabonomics