Exercise, immunity and vaccination in chronic obstructive pulmonary disease (COPD)

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12624000372583
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-28
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Adults (18 years or over)
- Diagnosis of COPD (according to Global Initiative for Chronic Obstructive Lung Disease criteria: post bronchodilator FEV1/FVC ratio <0.70
- Disease severity classified as either GOLD C or D according to 2017 guidelines (Exacerbations in previous 12 months: greater than or equal to 2 courses of systemic corticosteroids and/or antibiotics or greater than or equal to 1 hospital admission

Exclusion Criteria

- Already vaccinated with the influenza vaccine in the study season or not eligible for COVID-19 booster.
- Any history of allergies, suspected hypersensitivity and/or contraindication to vaccines (e.g. egg protein allergy)
- Participation in another clinical trial (use of investigational product or device)
- Current enrolled on a structured physical activity programme or reports completing greater than or equal to 150 minutes of moderate intensity activity or greater than or equal to 75 minutes of vigorous intensity activity per week
- Comorbidities that preclude exercise training
- Clinical instability, defined as experiencing a COPD exacerbation less than 4 weeks prior to baseline visit, as indicated by treatment with systemic corticosteroids and/or antibiotics and/or hospitalisation
- Diagnosis of asthma and/or other relevant lung disease (e.g. history of primary or clinically significant bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], active tuberculosis)
- Known alpha-1-antitrypsin deficiency
- Primary immunodeficiency (e.g. common variable immune deficiency, agammaglobulinemia) or severe immunocompromised conditions (active haematological malignancy, long-term haemodialysis or peritoneal dialysis, advanced or untreated HIV)
- Currently taking immunosuppressive medications except inhaled corticosteroids (e.g. prednisolone, cyclosporine, chemotherapy)
- Not enrolled in Medicare
- Unable to read and speak English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This will be assessed as a co-primary outcome of Recruitment and Completeness of follow-up<br>[- Recruitment: number of eligible participants consenting to take part in study via audit of trial screening records (feasibility threshold of 30%)<br>- Completeness of follow-up: number of participants attending all study visits via audit of study visit attendance (feasibility threshold of 80% of all participants)<br> End of trial follow-up of all participants]