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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05681364
Collaborator
(none)
300
23

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: metabonomics

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm 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.

Other: metabonomics
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.

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

Outcome Measures

Primary Outcome Measures

  1. Pulmonary rehabilitation outcome [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. α1 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Principal Investigator: Fei Wang, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT05681364
Other Study ID Numbers:
  • 01
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2023