Systemic Consequences and Comorbidities in Mild/Moderate COPD, Time for Action!
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome)
研究概览
简要总结
The aim of this prospective case-control study is to investigate the prevalence, severity and incidence of systemic consequences in newly detected patients with mild and moderate Chronic obstructive pulmonary disease (COPD). Special attention will be paid to skeletal muscle dysfunction and physical inactivity as these factors are, together with smoking, potentially modifiable.
详细描述
Three groups will be included in this study:
- Patients with COPD (cases)
- Patients with smoking history but no COPD (smoking controls)
- Patients with no smoking history and no COPD (non-smoking controls)
An extensive test battery will be performed at baseline and after 3 years:
Clinical assessment (height, weight and blood pressure)*
Complete pulmonary function ((post-bronchodilator)spirometry + diffusion)*
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 40-80 years old
- •cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment.
- •smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment.
- •non-smoking controls: no COPD (spirometry based) + < 1 pack year
排除标准
- •Respiratory disorder other than COPD
- •α1-antitrypsin deficiency
- •Known history of significant inflammatory disease other than COPD
- •COPD exacerbation within 4 weeks prior to study
- •Lung surgery
- •Recent diagnosis of cancer
- •Therapy with oral corticosteroids in the last 6 weeks
- •Significant cardiovascular comorbidity
- •Significant orthopedic/musculoskeletal problems
结局指标
主要结局
Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome)
时间窗: baseline
Common risk factors: smoking, COPD, physical inactivity (steps (per day)and moderate intense PA (min/day) and systemic inflammation (CRP, fibrinogen, IL-6, IL-8, TNF-alpha). Specific risk factors: vascular (atherosclerosis (mean IMT carotid arteries), arterial stenosis (ankle brachial index) and arterial stiffness (brachial ankle pulse wave velocity)), bone (osteopenia: T-score \< -1 at lumbar spine/femoral neck/total femur), muscle (fat free mass index \< 15/16(female/male) and respiratory/peripheral muscle weakness; \< 80%predicted), metabolic (syndrome): definition by AHA
Incidence and worsening of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome)
时间窗: 3 years
Common risk factors: smoking, COPD, physical inactivity (steps (per day)and moderate intense PA (min/day) and systemic inflammation (CRP, fibrinogen, IL-6, IL-8, TNF-alpha). Specific risk factors: vascular (atherosclerosis (mean IMT carotid arteries), arterial stenosis (ankle brachial index) and arterial stiffness (brachial ankle pulse wave velocity)), bone (osteopenia: T-score \< -1 at lumbar spine/femoral neck/total femur), muscle (fat free mass index \< 15/16 (female/male) and respiratory/peripheral muscle weakness; \< 80%predicted), metabolic (syndrome): definition by AHA
次要结局
未报告次要终点