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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05681364
• Other study ID #: 01
• Status: Not yet recruiting
• Start date: April 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: Peking University Third Hospital
• Contact: Fei Wang, MD
• Phone: 0086 13671304203
• Email: 13671304203[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• For COPD

1. Meets the Global initiative for chronic obstructive lung disease (GOLD) 2022 definition of stable COPD;

2. Age 30-75 years;

3. Lung CT images only showed chronic bronchitis and emphysema;

4. Agree to participate in the study and is able to cooperate with exhaled breath condensate collection.

• For bronchiectasis

1. Lung CT showed bronchiectasis;

2. Age 18-75 years;

3. 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:

1. Asthma or other respiratory diseases

2. History of pulmonary surgery

3. a1 antitrypsin deficiency

4. Autoimmune diseases

5. Patients with acute myocardial infarction, chronic heart failure, severe cerebral infarction or cerebral hemorrhage

6. A history of malignant disease now or within 2 years

7. History of acute exacerbation or change of medication in the past 4 weeks

8. A history of blood transfusion within the last 4 weeks

9. Drugs or alcohol abuse

10. Breastfeeding or pregnant women

11. Unable to cooperate with pulmonary rehabilitation for various reasons

Related Conditions & MeSH terms

• Bronchiectasis
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• metabonomics
profiles of metabolites in serum and exhale breath condensate (EBC) at baseline and after pulmonary rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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