Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Difference between the changes in number of steps per day (assessed over one week) from baseline to 12 months in the intervention group compared to controls.
研究概览
简要总结
Long-term evaluation of a coaching program which helps patients with severe COPD to increase their daily step count, in addition to usual care.
详细描述
Daily physical activity (PA) is a predictor of survival in the general population and has become a significant outcome measure in patients with COPD. Recent studies have demonstrated an independent association between PA, hospitalizations and mortality. Increased PA has significant benefits for patients with COPD. In most studies PA has only been assessed at one time point. Little is known about longitudinal changes in PA and data on determinants of changes in PA are scant. Moreover, information on best approaches to enhance PA in a population with decreasing PA is missing. To evaluate the long-term effect of a coaching program which is aimed at helping patients with severe COPD (FEV1<50%) to enhance their level of daily physical activity, in addition to usual care. Furthermore, this study aims to evaluate mechanisms that are responsible for changes of physical activity over time such as sociodemographic factors, lung function, comorbidities, vascular function, exacerbations, and medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age ≥ 40 years
- •Severe COPD (FEV1<50%) diagnosed according to GOLD-guidelines (www.goldcopd.org)
排除标准
- •Physical or intellectual impairment precluding informed consent or protocol adherence
- •Acute or recent (within the last 6 weeks) exacerbation of COPD
- •Attending a pulmonary rehabilitation program within the last 6 months
- •Pregnant patients
研究组 & 干预措施
Control
Usual care.
Intervention
An increase in step count of 15% compared to baseline will be set as the minimal goal for each patient during 3 months.
干预措施: Intervention (Behavioral)
结局指标
主要结局
Difference between the changes in number of steps per day (assessed over one week) from baseline to 12 months in the intervention group compared to controls.
时间窗: 12 months
At visits, the number of steps per day will be assessed by a multisensory band (SenseWear Pro™; Bodymedia Inc., Pittsburgh, PA, USA) which will be worn on the upper left arm for 7 consecutive days.
次要结局
- Assessment of endothelial function by flow-mediated dilatation(12 months)