Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.
2nd Department of Medicine - Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.
Trials. 2023 Aug 17;24(1):539. doi: 10.1186/s13063-023-07516-5.
Physical activity is an effective management strategy for heart failure with reduced ejection fraction, but patients' compliance is challenging. Walking is a suitable form of physical activity due to its convenience and sustainability, and it can potentially improve functional capacity in heart failure patients.
The WATCHFUL trial aims to determine whether a pedometer-based walking intervention combined with face-to-face sessions and regular telephone contact improves functional capacity in heart failure patients.
The WATCHFUL trial is a 6-month multicenter, parallel-group, randomized, controlled, superiority trial with a 6-month follow-up. A total of 202 patients were recruited for the trial. The primary analysis will evaluate the change in distance walked during the 6-min walk test from baseline to 6 months based on the intention-to-treat population; the analysis will be performed using a linear mixed-effect model adjusted for baseline values. Missing data will be imputed using multiple imputations, and the impact of missing data will be assessed using a sensitivity analysis. Adverse events are monitored and recorded throughout the trial period.
The trial has been designed as a pragmatic trial with a scalable intervention that could be easily translated into routine clinical care. The trial has been affected by the COVID-19 pandemic, which slowed patients' recruitment and impacted their physical activity patterns.
The present publication provides details of the planned statistical analyses for the WATCHFUL trial to reduce the risks of reporting bias and erroneous data-driven results.
ClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017).
体力活动是治疗射血分数降低的心力衰竭的有效管理策略，但患者的依从性具有挑战性。由于步行方便且可持续，因此是一种适合的体力活动形式，并且有可能改善心力衰竭患者的功能能力。
WATCHFUL 试验旨在确定基于计步器的步行干预措施与面对面会议和定期电话联系相结合是否能改善心力衰竭患者的功能能力。
WATCHFUL 试验是一项为期 6 个月的多中心、平行组、随机、对照、优效性试验，随访时间为 6 个月。共有 202 名患者参加了该试验。主要分析将根据意向治疗人群评估 6 分钟步行试验中从基线到 6 个月的步行距离变化；分析将使用线性混合效应模型进行，该模型根据基线值进行调整。将使用多重插补法处理缺失数据，并使用敏感性分析评估缺失数据的影响。试验期间监测和记录不良事件。
该试验设计为一项具有可扩展性干预措施的实用试验，可轻松转化为常规临床护理。该试验受到 COVID-19 大流行的影响，这减缓了患者的招募速度并影响了他们的体力活动模式。
本出版物提供了 WATCHFUL 试验计划的统计分析细节，以降低报告偏倚和错误的数据驱动结果的风险。
ClinicalTrials.gov（标识符：NCT03041610，注册日期：2017 年 3 月 2 日）。
