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

NCT05681364 | Unknown

• 1 other identifier: 01
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Bronchiectasis

Keywords

pulmonary rehabilitation; chronic respiratory disease; metabonomics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Other: metabonomics

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.

Other: metabonomics

Interventions

metabonomics OTHER

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

COPD and bronchiectasis patients with some metabolic profiling; COPD and bronchiectasis patients without the metabolic profiling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients in respiratory and critical care medicine department of Peking University Third Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and exhaled breath condensate

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiectasis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases

Study Officials

• Fei Wang

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wang, MD

CONTACT

0086 13671304203; 13671304203@139.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: January 12, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2022-10