Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Fei Wang, MD
- Phone Number: 0086 13671304203
- Email: 13671304203@139.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
COPD and bronchiectasis patients with some metabolic profiling
The patients with stable COPD and bronchiectasis who meet the screening criteria and with some metabolic profiling according to the previous studies.
|
profiles of metabolites in serum and exhale breath condensate (EBC) at baseline and after pulmonary rehabilitation
|
|
COPD and bronchiectasis patients without the metabolic profiling
The patients with stable COPD and bronchiectasis who meet the screening criteria and without the metabolic profiling according to the previous studies.
|
profiles of metabolites in serum and exhale breath condensate (EBC) at baseline and after pulmonary rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary rehabilitation outcome
Time Frame: 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. |
At week 12 of pulmonary rehabilitation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fei Wang, Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01 (Leona M. and Harry B. Helmsley Charitable Trust)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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