Effectiveness of an Intervention of Urban Training in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 412
- 试验地点
- 5
- 主要终点
- Change in physical activity
研究概览
简要总结
This project plans on a training intervention by using public spaces and urban walkable trails, adapted to each patient needs and capabilities. Primary objective is to assess 12 months effectiveness of the intervention with respect to: (primary outcome): physical activity level, and (secondary outcomes): COPD admissions, exercise capacity, body composition, quality of life, and mental health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 45 years
- •COPD diagnosed by pulmonary function tests during clinical stability, with a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ≤ 0.70
- •clinical stability, defined as at least 4 weeks without antibiotics or oral corticosteroids.
排除标准
- •living >6 months/year outside of the included municipalities,
- •living to a distance higher than 500 meters to any of the urban trails used for the study,
- •mental disability according to the Mini Mental State Examination in its validated Spanish version
- •comorbidity that could interfere with study tests (e.g., lower limb amputation)
- •severe psychiatric disease or severe comorbidity limiting survival at one year, according to medical history.
研究组 & 干预措施
Urban training Intervention
Patients will be advised to walk in the defined urban trails.
干预措施: Urban training (Behavioral)
Usual care
Patients will continue their usual care
结局指标
主要结局
Change in physical activity
时间窗: Baseline and 12 months follow-up
Change in physical activity between baseline and 12 months follow-up, as defined by average steps per day measured with an activity monitor
次要结局
- COPD admissions to emergency-room or hospital(12 months follow-up)
- Change in exercise capacity, as measured with 6-min walking distance(Baseline and 12 months)
- Change in body weight and composition(Baseline and 12 month)
- Change in quality of life(Baseline and 12-m)
- Change in anxiety and depression symptoms(Baseline and 12 months)
研究者
Judith Garcia-Aymerich
Associate Research Professor
Barcelona Institute for Global Health