Effects of 1-year exercise in patients with atrial fibrillation: study protocol for the Norwegian Exercise in Atrial Fibrillation (NEXAF) randomised controlled trial.
Bjarne M Nes, Jon Magne Letnes, Kristin Espolin Johnson, Andreas Berg Sellevold, Rune Byrkjeland, Fedelix Phetogo Brown, Turid Follestad, Håvard Dalen, Ulrik Wisløff, Maja-Lisa Løchen, Arnljot Tveit, Bente Morseth, Marius Myrstad, Jan Pål Loennechen
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引用次数: 0
Abstract
Introduction: Atrial fibrillation is the most prevalent sustained arrhythmia worldwide and is expected to increase substantially within the coming years. Although lifestyle changes and risk factor modification are now acknowledged as central components of atrial fibrillation management, the effects of exercise on disease-specific outcomes are still not extensively documented due to few high-quality randomised trials. The primary objective of the Norwegian Exercise in Atrial Fibrillation Trial (NEXAF) is to assess the effects of exercise over 12 months on key clinical and patient-reported outcomes in previously inactive patients with atrial fibrillation.
Methods and analysis: NEXAF is a multicentre, two-arm, randomised controlled trial inviting patients 18-80 years with a confirmed diagnosis of paroxysmal or persistent atrial fibrillation. Eligible patients are randomised 1:1 to either a combined supervised and eHealth-based exercise intervention or usual care for 12 months. The primary outcomes are total time in atrial fibrillation measured by insertable cardiac monitors, and disease-specific quality of life measured by the Atrial Fibrillation Effect on Quality-of-Life questionnaire.
Ethics and dissemination: Ethical approval was obtained from the Regional Ethics Committee in Mid-Norway in April 2021 (ID 213848).
期刊介绍：
Open Heart is an online-only, open access cardiology journal that aims to be “open” in many ways: open access (free access for all readers), open peer review (unblinded peer review) and open data (data sharing is encouraged). The goal is to ensure maximum transparency and maximum impact on research progress and patient care. The journal is dedicated to publishing high quality, peer reviewed medical research in all disciplines and therapeutic areas of cardiovascular medicine. Research is published across all study phases and designs, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Opinionated discussions on controversial topics are welcomed. Open Heart aims to operate a fast submission and review process with continuous publication online, to ensure timely, up-to-date research is available worldwide. The journal adheres to a rigorous and transparent peer review process, and all articles go through a statistical assessment to ensure robustness of the analyses. Open Heart is an official journal of the British Cardiovascular Society.
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