Exercise training in the treatment of paroxysmal atrial fibrillation: study protocol of the Cologne ExAfib Trial

INTRODUCTION: Atrial fibrillation (AF) is the most common form of cardiac arrhythmia and is associated with a number of comorbidities such as coronary artery disease and heart failure. While physical activity is already implemented in current international guidelines for the prevention and treatment of AF, the precise role of different types of exercise in the management of AF remains to be elucidated. The primary aim of the Cologne ExAfib Trial is to assess the feasibility and safety of different exercise modes in patients diagnosed with paroxysmal AF. Secondary outcomes include assessments of physical function, AF burden, quality of life and inflammation, as well as morphological and cardiac adaptations. METHODS AND ANALYSIS: The study opened for recruitment in September 2019. In the initial pilot phase of this four-armed randomised controlled trial, we aim to enrol 60 patients between 60 years and 80 years of age with paroxysmal AF. After screening and pretesting, patients are randomised into one of the following groups: high-intensity interval training (4×4 min at 75%–85% peak power output (PPO)), moderate-intensity continuous training (25 min at 55%–65% PPO), strength training (whole body, 3 sets of 6–12 repetitions at 70%–90% one repetition maximum [1RM]) or a usual-care control group. Training is performed two times per week for 12 weeks. If the feasibility and safety can be confirmed through the initial pilot phase, the recruitment will be continued and powered for a clinical endpoint. Feasibility and safety are assessed by measures of recruitment and completion, programme tolerance and adherence as well as reported adverse events, including hospitalisation rates. Secondary endpoints are assessed by measures of peak oxygen consumption and the 1RM of selected muscle groups, questionnaires concerning quality of life and AF burden, serum blood samples for the analysis of C reactive protein, interleukin-6, tumour necrosis factor alpha and N-terminal pro-brain natriuretic peptide concentrations and ultrasound for muscle and heart morphology as well as cardiac function. ETHICS AND DISSEMINATION: Ethics approval was obtained from the ethics committee of the German Sport University Cologne (No.: 175/2018). All procedures performed in studies involving human participants are in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Manuscripts will be written based on international authorship guidelines. No professional writers will be commissioned for manuscript drafting. The findings of this study will be published in peer-reviewed journals and presented at leading exercise and medicine conferences TRIAL REGISTRATION NUMBER: The study is registered both at the German and at the WHO trial registers (DRKS00016637); Pre-results.