BACKGROUND: 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. OBJECTIVES: 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. METHODS: 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. DISCUSSION: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017).

1st Department of Internal Medicine Cardioangiology Faculty of Medicine in Hradec Kralove Charles University Prague Czech Republic

2nd Department of Medicine Department of Cardiovascular Medicine 1st Faculty of Medicine Charles University and General University Hospital Prague Prague Czech Republic

Cardiology Department University Hospital Brno and Medical Faculty of the Masaryk University Brno Czech Republic

Department of Cardiology Tomas Bata Regional Hospital Zlin Czech Republic

Department of Internal Medicine 1 Cardiology University Hospital Olomouc Olomouc Czech Republic

Edumed S R O Broumov Czech Republic

Faculty of Medicine in Hradec Kralove Charles University Prague Czech Republic

Faculty of Physical Education and Sport Charles University Prague Czech Republic

Innere Medizin 1 Abteilung Für Kardiologie Und Internistische Intensivmedizin Landesklinikum Mistelbach Mistelbach Austria

Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Brno Czech Republic

University Hospital Hradec Kralove Hradec Králové Czech Republic

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Lifestyle Walking Intervention for Patients With Heart Failure With Reduced Ejection Fraction: The WATCHFUL Trial

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ClinicalTrials.gov
NCT03041610