Effects of 1-year exercise in patients with atrial fibrillation: Study protocol for the Norwegian Exercise in Atrial Fibrillation (NEXAF) randomised controlled trial

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). Trial registration number NCT05164718.