The Norwegian Exercise in Atrial Fibrillation Trial

Summary

Atrial fibrillation (AF) patients suffer a high symptom burden and reduced quality of life (QoL), high hospitalization rates and few effective treatment options. They have a high burden of cardiovascular risk factors and events. Lifestyle changes and exercise is a cornerstone of management in most chronic cardiac conditions and holds promise in AF, but the evidence is sparse and specific guidelines for exercise do not exist for AF patients. NEXAF is a large-scale multicenter randomized trial to determine the feasibility and effects of exercise on patient-reported and clinical outcomes. All patients will undergo continuous rhythm monitoring, enabling assessment of duration, frequency and total time of AF episodes. The overall aim of the study is to provide documentation for clinical exercise recommendations in AF. The objectives are to examine the effects of a 1-year exercise intervention in AF patients on (i) QoL and symptom burden, (ii) time-in-AF, and peak oxygen uptake, cardiac structure and function, cardiovascular risk factors and use of healthcare resources.

Conditions

• Atrial Fibrillation

Interventions

BEHAVIORAL

Supervised home-based exercise

150-300 minutes of moderate intensity activity (55-75% of maximum heart rate in sinus rhythm or RPE 12-13 on the Borg Scale) or 75-150 minutes of vigorous intensity activity (75-90% of maximum heart rate or 14-16 on the Borg Scale) per week, or an equivalent combination of both, according to current general recommendations, including also those with established CVD. To maximize the potential for improvements in cardiorespiratory fitness, we encourage that at least 40-60 minutes per week (i.e. 2 sessions á 20-30 minutes) should be of vigorous intensity.

OTHER

Usual care

Standard management according to usual practice at the respective participating centers, including medical therapy as per guidelines. Prior to randomization all will be provided an ICM (Confirm RX™). The UC group will receive information about general PA recommendations as per guidelines at study enrollment. No further supervision is given.

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• UiT The Arctic University of Norway

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Vestre Viken Hospital Trust

  collaborator OTHER

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Øystein Risa · NTNU, Department of Circulation and Medical Imaging

• Rune Wiseth, md phd · St Olavs Hospital, Clinic of Cardiology

• Bjarne M Ness, phd · NTNU, Department of Circulation and Imaging

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-04

Primary Completion

2025-06-30

Completion

2025-12-31

Countries

• Norway

Study Locations