Paediatric Department, Julius-Maximilians University, Josef-Schneider-Str. 2, 97080, Würzburg, Germany.
Montreal Children's Hospital, McGill University Health Centre, Montreal, Quebec, Canada.
BMC Pulm Med. 2018 Feb 8;18(1):31. doi: 10.1186/s12890-018-0596-6.
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 (FEV) 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 FEV ≥ 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.
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.
ClinicalTrials.gov Identifier: NCT01744561 ; Registration date: December 6, 2012.
体力活动（PA）和运动已成为囊性纤维化（CF）护理中被广泛接受和重视的组成部分。定期进行 PA 和运动可以对肺功能产生积极影响，提高身体素质，并改善健康相关生活质量（HRQoL）。然而，激励人们更加活跃是具有挑战性的。监督下的运动计划昂贵且劳动强度大，一旦监督结束，依从性会显著下降。非监督或部分监督的计划成本较低且更灵活，但合规性可能更成问题。本研究的主要目的是评估部分监督的运动干预以及定期激励对大型国际 CF 患者群体中 1 秒用力呼气量（FEV）在 6 个月时的影响。次要终点包括患者报告的 HRQoL，以及焦虑和抑郁水平以及血糖控制。
方法/设计：计划将总共招募 292 名年龄在 12 岁及以上且 FEV 预测值≥35%的 CF 患者进行随机分组。在基线评估（2 次就诊）后，患者被随机分为干预组和对照组。此后，他们将每 3 个月在他们的中心进行一次评估，为期一年（4 次随访）。除了在每次就诊时通过个人咨询增加至少 3 小时的剧烈 PA 外，干预组还记录日常 PA 和不活动时间，并使用计步器在基于网络的日记中记录他们的进展。他们还在研究期间每月从研究人员那里获得一次电话。在研究的前 6 个月后，他们继续使用计步器和基于网络的程序再进行 6 个月。对照组在研究期间保持其 PA 水平不变，并接受标准护理。此后，他们也接受干预。
这是第一项使用现代技术调查 CF 中 PA 干预与动机反馈对多种健康结果影响的大型国际多中心研究。如果这个相对简单的方案被证明是成功的，它将在国际范围内更广泛地推广。
ClinicalTrials.gov 标识符：NCT01744561；注册日期：2012 年 12 月 6 日。
