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

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease; Bronchiectasis
• Interventions: Other: metabonomics

• Registration Number: NCT05681364
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-12
• Study Start: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD and bronchiectasis patients with some metabolic profiling	metabonomics	The patients with stable COPD and bronchiectasis who meet the screening criteria and with some metabolic profiling according to the previous studies.
COPD and bronchiectasis patients without the metabolic profiling	metabonomics	The patients with stable COPD and bronchiectasis who meet the screening criteria and without the metabolic profiling according to the previous studies.

Primary Outcome Measures

Name	Time	Method
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.