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Clinical Trials/ACTRN12624000372583
ACTRN12624000372583
Recruiting
未知

Exercise as an immunomodulatory intervention and adjuvant to vaccination in people with COPD: feasibility randomised controlled trial

Monash University0 sites45 target enrollmentMarch 28, 2024

Overview

Phase
未知
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Monash University
Enrollment
45
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 28, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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