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  • The effect of integrated cardiac rehabilitation versus treatment as usual for atrial fibrillation patients treated with ablation: the randomised CopenHeartRFA trial protocol

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Rehabilitation medicine
Protocol
The effect of integrated cardiac rehabilitation versus treatment as usual for atrial fibrillation patients treated with ablation: the randomised CopenHeartRFA trial protocol
  1. Signe Stelling Risom1,
  2. Ann-Dorth Olsen Zwisler1,2,
  3. Trine Bernholdt Rasmussen1,3,
  4. Kirstine Lærum Sibilitz1,
  5. Jesper Hastrup Svendsen1,4,
  6. Christian Gluud5,
  7. Jane Lindschou Hansen5,
  8. Per Winkel5,
  9. Lau Caspar Thygesen2,
  10. Merja Perhonen6,
  11. Jim Hansen3,
  12. Sandra B Dunbar7,
  13. Selina Kikkenborg Berg1,3
  1. 1The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen Denmark
  2. 2National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark
  3. 3The Danish National Research Foundation Centre for Cardiac Arrhythmia (DARC), Copenhagen, Denmark
  4. 4Department of Cardiology, Gentofte Hospital, Gentofte, Denmark
  5. 5Copenhagen Trial Unit, Centre for Clinical Intervention Research. Copenhagen University Hospital, Copenhagen, Denmark
  6. 6CorusFit, Jyväskylä, Finland
  7. 7Nell Hodgson Woodruff School of Nursing, Emory University Atlanta, Druid Hills, Georgia, USA
  1. Correspondence to Signe Stelling Risom; Signe.stelling.risom{at}rh.regionh.dk

Abstract

Introduction Atrial fibrillation affects almost 2% of the population in the Western world. To preserve sinus rhythm, ablation is undertaken in symptomatic patients. Observational studies show that patients with atrial fibrillation often report a low quality of life and are less prone to be physically active due to fear of triggering fibrillation. Small trials indicate that exercise training has a positive effect on exercise capacity and mental health, and both patients with recurrent atrial fibrillation and in sinus rhythm may benefit from rehabilitation in managing life after ablation. No randomised trials have been published on cardiac rehabilitation for atrial fibrillation patients treated with ablation that includes exercise and psychoeducational components.

Aim To test the effects of an integrated cardiac rehabilitation programme versus treatment as usual for patients with atrial fibrillation treated with ablation.

Methods and analysis design The trial is a multicentre parallel arm design with 1:1 randomisation to the intervention and control group with blinded outcome assessment. 210 patients treated for atrial fibrillation with radiofrequency ablation will be included. The intervention consists of a rehabilitation programme including four psychoeducative consultations with a specially trained nurse and 12 weeks of individualised exercise training, plus the standard medical follow-up. Patients in the control group will receive the standard medical follow-up. The primary outcome measure is exercise capacity measured by the VO2 peak. The secondary outcome measure is self-rated mental health measured by the Short Form 36 questionnaire. Postintervention, qualitative interviews will be conducted in 10% of the intervention group.

Ethics and dissemination The protocol is approved by the regional research ethics committee (number H-1-2011-135), the Danish Data Protection Agency (reg. nr. 2007-58-0015) and follows the latest version of the Declaration of Helsinki. The results will be published in peer-reviewed journals and may possibly impact on rehabilitation guidelines.

Trial registration Clinicaltrials.gov identifier: NCT01523145.

  • Atrial Fibrillation
  • QUALITATIVE RESEARCH

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode

https://doi.org/10.1136/bmjopen-2012-002377

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