Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol
Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol
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DOI：
10.1186/s12890-018-0596-6
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发表时间：
2018-02-08
影响因子：
3.1
通讯作者：
Radtke, Thomas
中科院分区：
文献类型：
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作者：
Hebestreit, Helge;Lands, Larry C.;Radtke, Thomas
背景：体力活动（PA）和运动已成为囊性纤维化（CF）护理的一个公认和有价值的组成部分。定期PA和运动可以积极影响肺功能，改善体质，提高健康相关的生活质量（HRQoL）。然而，激励人们更加积极是一项挑战。监督锻炼计划是昂贵的和劳动密集型的，一旦监督结束，坚持福尔斯会显著下降。无监督或部分监督的计划成本更低，更灵活，但合规性可能更成问题。本研究的主要目的是评价部分监督运动干预沿着有规律的运动对大型国际CF患者组6个月时1秒用力呼气量（FEV 1）的影响。次要终点包括患者报告的HRQoL，以及焦虑和抑郁的水平，和控制血糖。方法/设计：它计划，共292例CF 12岁及以上的FEV 1>= 35%预测应随机。基线评估（2次访视）后，将患者随机分为干预组和对照组。此后，他们将每3个月在其中心接受一次评估，为期一年（4次随访访视）。沿着个人咨询，在每次门诊访视时每周增加至少3小时的剧烈PA，干预组记录每日PA和不活动时间，并收到一个步计数器，以在基于网络的日记中记录其进展。在研究的前6个月，他们还每月收到研究工作人员的电话。6个月后，他们继续进行为期6个月的步数计数器和基于网络的方案。对照组接受标准护理，并在研究期间保持PA水平恒定。讨论：这是第一个大型的，国际多中心的研究调查的影响，PA干预CF与动机反馈的几个健康结果，使用现代技术。如果这个相对简单的方案证明是成功的，它将在国际上更广泛地提供。
Background: Physical activity (PA) and exercise have become an accepted and valued component of cystic fibrosis (CF) care. Regular PA and exercise can positively impact pulmonary function, improve physical fitness, and enhance health-related quality of life (HRQoL). However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labour intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 s (FEV1) at 6 months in a large international group of CF patients. Secondary endpoints include patient reported HRQoL, as well as levels of anxiety and depression, and control of blood sugar.Methods/design: It is planned that a total of 292 patients with CF 12 years and older with a FEV1 >= 35% predicted shall be randomised. Following baseline assessments (2 visits) patients are randomised into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counselling to increase vigorous PA by at least 3 h per week on each clinic visit, the intervention group documents daily PA and inactivity time and receives a step counter to record their progress within a web-based diary. They also receive monthly phone calls from the study staff during the first 6 months of the study. After 6 months, they continue with the step counter and web-based programme for a further 6 months. The control group receives standard care and keeps their PA level constant during the study period. Thereafter, they receive the intervention as well.Discussion: This is the first large, international multi-centre study to investigate the effects of a PA intervention in CF with motivational feedback on several health outcomes using modern technology. Should this relatively simple programme prove successful, it will be made available on a wider scale internationally.