ACTRN12624000372583招募中Unknown
Exercise as an immunomodulatory intervention and adjuvant to vaccination in people with COPD: feasibility randomised controlled trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •- 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
研究者
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