A Prospective Observational Study on the Effects of Obesity on Symptoms, Health Related Quality of Life and Pulmonary Function in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Dyspnoea - NCSI
研究概览
简要总结
The purpose of this study is to investigate whether obese COPD patients experience more or less discomfort in daily life. Furthermore the investigators will evaluate if body composition or body fat distribution has effects on symptoms and performance.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) and Obesity are two major health problems. The prevalence of both is growing and there is a complex interaction between COPD and obesity. On the one hand obesity impairs lung function, with decreasing static lung volumes being the most significant effect. On the other hand there seems a beneficial role of obesity on lung function in COPD patients. This is because obese COPD patients tend to have less hyperinflation than non-obese COPD patients . An interesting question is what the net effect of these changes in lung function is on respiratory symptoms and quality of life.
In this observational study, the investigators will compare obese and non-obese COPD patients. Pulmonary function, dyspnea and quality of life will be compared between the two groups.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with COPD by a Pulmonologist defined as an obstructive lung function test with FEV1/FVC < 0.7 and FEV1 < 80% predicted
- •No exacerbation of COPD at time of inclusion
- •Age > 18 years
- •Able to perform lung function tests and fill in the questionnaires.
排除标准
- •Not able to perform lung function tests or fill in the questionnaires
- •Diagnosis of Asthma
- •Diagnosis of neuromuscular disease
- •Diagnosis of heart failure
- •Treatment for lung Malignancy in the past
- •Active Malignancy
结局指标
主要结局
Dyspnoea - NCSI
时间窗: At inclusion
Level of dyspnoea perceived in daily life measured using the Nijmegen Clinical Screening Instrument (NCSI). The NCSI ranges from grade 0 to 11. Higher scores mean a worse outcome.
Dyspnoea - mMRC
时间窗: At inclusion
Level of dyspnoea perceived in daily life measured using the Modified Medical Research Council (mMRC) dyspnoea scale. The mMRC dyspnoea scale ranges from grade 0 to 4. Higher scores mean a worse outcome.
Change in dyspnoea
时间窗: Before and after the 6 minute walking test
Level of dyspnoea using the Borg score. The Borg score ranges from grade 0 to 10. Higher scores mean a worse outcome.
次要结局
- 6 minute walking test(At inclusion)