Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial.

Autor: Vetrovsky T; Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic. tomas.vetrovsky@gmail.com., Siranec M; 2nd Department of Medicine - Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic., Frybova T; 2nd Department of Medicine - Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic., Gant I; 2nd Department of Medicine - Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic., Semerad M; Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic., Miklikova M; Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University, Brno, Czech Republic., Bunc V; Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic., Vesely J; Faculty of Medicine in Hradec Kralove, Charles University, Prague, Czech Republic.; Edumed S.R.O, Broumov, Czech Republic., Stastny J; Department of Cardiology, Tomas Bata Regional Hospital, Zlin, Czech Republic., Griva M; Department of Cardiology, Tomas Bata Regional Hospital, Zlin, Czech Republic.; Innere Medizin I - Abteilung Für Kardiologie Und Internistische Intensivmedizin, Landesklinikum Mistelbach, Mistelbach, Austria., Precek J; Department of Internal Medicine I - Cardiology, University Hospital Olomouc, Olomouc, Czech Republic., Pelouch R; 1st Department of Internal Medicine - Cardioangiology, Faculty of Medicine in Hradec Kralove, Charles University, Prague, Czech Republic.; University Hospital Hradec Kralove, Hradec Králové, Czech Republic., Parenica J; Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University, Brno, Czech Republic., Jarkovsky J; Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic., Belohlavek J; 2nd Department of Medicine - Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Aug 17; Vol. 24 (1), pp. 539. Date of Electronic Publication: 2023 Aug 17.
DOI: 10.1186/s13063-023-07516-5
Abstrakt: 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).
(© 2023. BioMed Central Ltd., part of Springer Nature.)
Databáze: MEDLINE
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