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

Signe Stelling Risom, Ann-Dorth Olsen Zwisler, Trine Bernholdt Rasmussen, Kirstine Lærum Sibilitz, Jesper Hastrup Svendsen, Christian Gluud, Jane Lindschou Hansen, Per Winkel, Lau Caspar Thygesen, Merja Perhonen, Jim Hansen, Sandra B Dunbar, Selina Kikkenborg Berg, Signe Stelling Risom, Ann-Dorth Olsen Zwisler, Trine Bernholdt Rasmussen, Kirstine Lærum Sibilitz, Jesper Hastrup Svendsen, Christian Gluud, Jane Lindschou Hansen, Per Winkel, Lau Caspar Thygesen, Merja Perhonen, Jim Hansen, Sandra B Dunbar, Selina Kikkenborg Berg

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 VO(2) 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.

Figures

Figure 1
Figure 1
The CopenHeartRFA trial. Mixed methods research design. Embedded Experimental Model. QUAN, quantitative data, QUAL, qualitative data.
Figure 2
Figure 2
The flow of patients through the trial.

References

    1. Stewart S, Hart CL, Hole DJ, et al. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study . Heart 2001;86:516–21
    1. Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study . JAMA 2001;285:2370–5
    1. Ruigomez A, Johansson S, Wallander MA, et al. Predictors and prognosis of paroxysmal atrial fibrillation in general practice in the UK . BMC Cardiovasc Disord 2005;5:20.
    1. European Heart Rhythm Association, European Association for Cardio-Thoracic Surgery Camm AJ, Kirchhof P, Lip GYet al. Guidelines for the management of atrial fibrillation: the Task Force for the management of atrial fibrillation of the European Society of Cardiology (ESC) . Europace 2010;12:1360–420
    1. Lafuente-Lafuente C, Mouly S, Longas-Tejero MA, et al. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atral fibrillation (Review) 2009;The Cochrane Libraly(1)
    1. Kirchhof P, Auricchio A, Bax J, et al. Outcome parameters for trials in atrial fibrillation: recommendations from a consensus conference organized by the German Atrial Fibrillation Competence NETwork and the European Heart Rhythm Association . Europace 2007;9:1006–23
    1. Stewart S, Hart CL, Hole DJ, et al. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study . Am J Med 2002;113:359–64
    1. Camm J. Antiarrhythmic drugs for the maintenance of sinus rhythm: risks and benefits. Int J Cardiol 2011;155:362–71
    1. Heeringa J, van der Kuip DA, Hofman A, et al. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study . Eur Heart J 2006;27:949–53
    1. Naccarelli GV, Varker H, Lin J, et al. Increasing prevalence of atrial fibrillation and flutter in the United States . Am J Cardiol 2009;104:1534–9
    1. Lloyd-Jones DM, Wang TJ, Leip EP, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study . Circulation 2004;110:1042–6
    1. Ericson L, Bergfeldt L, Bjorholt I. Atrial fibrillation: the cost of illness in Sweden . Eur J Health Econ 2011;12:479–87
    1. Wolowacz SE, Samuel M, Brennan VK, et al. The cost of illness of atrial fibrillation: a systematic review of the recent literature . Europace 2011;13:1375–85
    1. Brenyo AJ, Aktas MK. Non-pharmacologic management of atrial fibrillation . Am J Cardiol 2011;108:317–25
    1. Calkins H, Reynolds MR, Spector P, et al. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses . Circ Arrhythm Electrophysiol 2009;2:349–61
    1. Atwood JE, Myers JN, Tang XC, et al. Exercise capacity in atrial fibrillation: a substudy of the Sotalol-Amiodarone Atrial Fibrillation Efficacy Trial (SAFE-T) . Am Heart J 2007;153:566–72
    1. Hansson A, Madsen-Hardig B, Olsson SB. Arrhythmia-provoking factors and symptoms at the onset of paroxysmal atrial fibrillation: a study based on interviews with 100 patients seeking hospital assistance . BMC Cardiovasc Disord 2004;4:13.
    1. Hegbom F, Sire S, Heldal M, et al. Short-term exercise training in patients with chronic atrial fibrillation: effects on exercise capacity, AV conduction, and quality of life . J Cardiopulm Rehabil 2006;26:24–9
    1. Hegbom F, Stavem K, Sire S, et al. Effects of short-term exercise training on symptoms and quality of life in patients with chronic atrial fibrillation . Int J Cardiol 2007;116:86–92
    1. Osbak PS, Mourier M, Kjaer A, et al. A randomized study of the effects of exercise training on patients with atrial fibrillation . Am Heart J 2011;162:1080–7
    1. Dorian P, Jung W, Newman D, et al. The impairment of health-related quality of life in patients with intermittent atrial fibrillation: implications for the assessment of investigational therapy . J Am Coll Cardiol 2000;36:1303–9
    1. McCabe PJ, Schumacher K, Barnason SA. Living with atrial fibrillation: a qualitative study . J Cardiovasc Nurs 2011;26:336–44
    1. Piepoli MF, Corra U, Benzer W, et al. Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil 2010;17:1–17
    1. Piepoli MF, Corra U, Adamopoulos S, et al. Secondary prevention in the clinical management of patients with cardiovascular diseases. Core components, standards and outcome measures for referral and delivery. Eur J Prev Cardiol 2012 Jun 20 [Epub ahead of print]
    1. Heran BS, Chen JM, Ebrahim S, et al. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev 2011;(7):CD001800.
    1. Davies EJ, Moxham T, Rees K, et al. Exercise based rehabilitation for heart failure. Cochrane Database Syst Rev 2010;(4):CD003331.
    1. Shepherd CW, While AE. Cardiac rehabilitation and quality of life: a systematic review . Int J Nurs Stud 2012;49:755–71
    1. Sire S. Physical training and occupational rehabilitation after aortic valve replacement . Eur Heart J 1987;8:1215–20
    1. Kitzman DW, Brubaker PH, Morgan TM, et al. Exercise training in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial . Circ Heart Fail 2010;3:659–67
    1. Clark AM, Catto S, Bowman G, et al. Design matters in secondary prevention: individualization and supervised exercise improves the effectiveness of cardiac rehabilitation . Eur J Cardiovasc Prev Rehabil 2011;18:761–9
    1. Clark AM, Haykowsky M, Kryworuchko J, et al. A meta-analysis of randomized control trials of home-based secondary prevention programs for coronary artery disease . Eur J Cardiovasc Prev Rehabil 2010;17:261–70
    1. Whalley B, Rees K, Davies P, et al. Psychological interventions for coronary heart disease. Cochrane Database Syst Rev 2011;(8):CD002902.
    1. Berg SK. Comprehensive rehabilitation for patients with ICD: PhD dissertation. Aarhus: Faculty of Health Sciences, Aarhus University, 2011
    1. Rasmussen TB, Zwisler AD, Sibilitz KL, et al. A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis—the CopenHeartIE. BMJ Open 2012;2:e001929
    1. Creswell JW, Plano Clark VL. Designing and conducting mixed methods research. Thousand Oaks, CA: SAGE Publications, 2007
    1. O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed methods studies . BMJ 2010;341:c4587.
    1. Carter RE, Lubinsky J, Domholdt E. Rehabilitation research: principles and applications. 4th edn St. Louis, MO: Elsevier Saunders, 2011
    1. Law MC, MacDermid J. Evidence-based rehabilitation: a guide to practice. 2nd edn Thorofare, NJ: Slack, 2008
    1. Clark N, Boyd NR, Goodman RM, et al. Evaluation of health promotion, health education, and disease prevention programs. 3rd edn Boston: McGraw-Hill, 2004
    1. Hammell KW, Carpenter C. Qualitative research in evidence-based rehabilitation. Edinburgh: Churchill Livingstone, 2004
    1. Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study . BMJ 2009;339:b3496.
    1. Neubeck L, Freedman SB, Clark AM, et al. Participating in cardiac rehabilitation: a systematic review and meta-synthesis of qualitative data . Eur J Prev Cardiol 2012;19:494–503
    1. Chan A, Tetzlaff J, Altman D, et al. The SPIRIT initiative: defining Standard Protocol Items for Randomized Trials [conference abstract] . German J Evid Quality Health Care (Suppl) 2008;102:S27
    1. Boutron I, Moher D, Altman DG, et al. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration . Ann Intern Med 2008;148:295–309
    1. Mertens DJ, Kavanagh T. Exercise training for patients with chronic atrial fibrillation . J Cardiopulm Rehabil 1996;16:193–6
    1. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories ATS statement: guidelines for the six-minute walk test . Am J Respir Crit Care Med 2002;166:111–17
    1. Rikli RE, Jones CJ. Senior fitness test manual. Champaign, IL: Human Kinetics, 2001
    1. Ekholm O, Hesse U, Davidsen M, et al. The study design and characteristics of the Danish national health interview surveys . Scand J Public Health 2009;37:758–65
    1. Ware JE, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation guide. Boston MA: The Health Institute, New England Medical Center, 2005
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale . Acta Psychiatr Scand 1983;67:361–70
    1. Ferrans CE, Powers MJ. Quality of life index: development and psychometric properties . Adv Nurs Sci 1985;8:15–24
    1. Bowman G, Watson R, Trotman-Beasty A. Primary emotions in patients after myocardial infarction . J Adv Nurs 2006;53:636–45
    1. Bøgelund M, Mønsted C. Hjertepatienters brug og oplevelse af rehabilitering 2010. Copenhagen: Hjerteforeningen, 2010
    1. Oldridge N, Saner H, McGee HM, et al. The Euro Cardio-QoL Project. An international study to develop a core heart disease health-related quality of life questionnaire, the HeartQoL. Eur J Cardiovasc Prev Rehabil 2005;12:87–94
    1. Drummond MF. Methods for the economic evaluation of health care programmes. 3rd edn Oxford: Oxford University Press, 2005
    1. Hallal PC, Victora CG. Reliability and validity of the International Physical Activity Questionnaire (IPAQ) . Med Sci Sports Exerc 2004;36:556.
    1. Schwartz JE, Jandorf L, Krupp LB. The measurement of fatigue: a new instrument . J Psychosom Res 1993;37:753–62
    1. Buysse DJ, Reynolds CF, 3rd, Monk TH, et al. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research . Psychiatry Res 1989;28:193–213
    1. Spertus J, Dorian P, Bubien R, et al. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation . Circ Arrhythm Electrophysiol 2011;4:15–25
    1. Berg SK, Svendsen JH, Zwisler AD, et al. COPE-ICD: a randomised clinical trial studying the effects and meaning of a comprehensive rehabilitation programme for ICD recipients -design, intervention and population . BMC Cardiovasc Disord 2011;11:33.
    1. Zwisler A, Madsen M, Konstantin Nissen N. Hjerterehabilitering: en medicinsk teknologivurdering: evidens fra litteraturen og DANREHAB-forsøget. Version: 1,0 ed Kbh: Sundhedsstyrelsen, 2006. (accessed 12 Aug 2012).
    1. Anbefalinger for fysisk aktivitet. (accessed 13 Sep 2011)
    1. Oerkild B, Frederiksen M, Hansen JF, et al. Home-based cardiac rehabilitation is as effective as centre-based cardiac rehabilitation among elderly with coronary heart disease: results from a randomised clinical trial . Age Ageing 2011;40:78–85
    1. Fitchet A, Doherty PJ, Bundy C, et al. Comprehensive cardiac rehabilitation programme for implantable cardioverter-defibrillator patients: a randomised controlled trial . Heart 2003;89:155–60
    1. Lampman RM, Knight BP. Prescribing exercise training for patients with defibrillators . Am J Phys Med Rehabil 2000;79:292–7
    1. Parse RR. The human becoming school of thought: a perspective for nurses and other health professionals. Thousand Oaks, CA: Sage, 1998
    1. Berg SK, Pedersen BD, Svendsen JH, et al. COPE-ICD: patient experience of participation in an ICD specific rehabilitation programme . Eur J Cardiovasc Nurs 2012;11:207–15
    1. Mezzani A, Agostoni P, Cohen-Solal A, et al. Standards for the use of cardiopulmonary exercise testing for the functional evaluation of cardiac patients: a report from the Exercise Physiology Section of the European Association for Cardiovascular Prevention and Rehabilitation . Eur J Cardiovasc Prev Rehabil 2009;16:249–67
    1. Gibbons L, Blair SN, Kohl HW, et al. The safety of maximal exercise testing . Circulation 1989;80:846–52
    1. Bjørner JB, Trab Damsgaard M, Watt T, et al. Dansk manual til SF-36: et spørgeskema om helbredsstatus. (S.l.): Lif, 1997
    1. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83
    1. McHorney CA, Ware JE, Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 1993;31:247–63
    1. Andersen TF, Madsen M, Jorgensen J, et al. The Danish National Hospital Register. A valuable source of data for modern health sciences. Dan Med Bull 1999;46:263–8
    1. Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register . Scand J Public Health 2011;39(7 Suppl):30–3
    1. Andersen JS, Olivarius Nde F, Krasnik A. The Danish National Health Service Register . Scand J Public Health 2011;39(7 Suppl):34–7
    1. Kildemoes HW, Sorensen HT, Hallas J. The Danish National Prescription Registry . Scand J Public Health 2011;39(7 Suppl):38–41
    1. Helweg-Larsen K. The Danish Register of Causes of Death . Scand J Public Health 2011;39(7 Suppl):26–9
    1. Borg GA. Psychophysical bases of perceived exertion . Med Sci Sports Exerc 1982;14:377–81
    1. DeSouza CM, Legedza AT, Sankoh AJ. An overview of practical approaches for handling missing data in clinical trials . J Biopharm Stat 2009;19:1055–73
    1. Dmitrienko A, Wiens BL, Tamhane AC, et al. Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives . Stat Med 2007;26:2465–78
    1. McHorney CA, Ware JE, Rogers W, et al. The validity and relative precision of MOS short- and long-form health status scales and Dartmouth COOP charts: results from the Medical Outcomes Study. Med Care 1992;30(Suppl):253–65
    1. Schweikert B, Hahmann H, Leidl R. Validation of the EuroQol questionnaire in cardiac rehabilitation . Heart 2006;92:62–7
    1. Polit DF, Beck CT. Essentials of nursing research: methods, appraisal, and utilization. 6 edn Philadelphia, PA: Lippincott Williams & Wilkins, 2006
    1. Ricoeur P. Interpretation theory: discourse and the surplus of meaning. 5th print edn Fort Worth, TX: Texas Christian University Press, 1976
    1. EuroQol–a new facility for the measurement of health-related quality of life. The EuroQol Group . Health Policy 1990;16:199–208
    1. Brooks R. EuroQol: the current state of play . Health Policy 1996;37:53–72
    1. Wittrup-Jensen KU, Lauridsen J, Gudex C, et al. Generation of a Danish TTO value set for EQ-5D health states . Scand J Public Health 2009;37:459–66
    1. Fox-Rushby JA, Cairns J. Economic evaluation. Maidenhead: Open University Press, 2005
    1. Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves . Health Econ 2001;10:779–87
    1. Taylor RS, Brown A, Ebrahim S, et al. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials . Am J Med 2004;116:682–92
    1. Rees K, Taylor RS, Singh S, et al. Exercise based rehabilitation for heart failure. Cochrane Database Syst Rev 2004;(3):CD003331.
    1. Wood L, Egger M, Gluud LL, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study . BMJ 2008;336:601–5
    1. Gluud L. Bias in clinical intervention research. Am J Epidemiol 2006;163:493–501
    1. Savovic J, Jones H, Altman D, et al. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials: combined analysis of meta-epidemiological studies . Health Technol Assess 2012;16: 1–82
    1. Rowland T, Unnithan V, Barker P, et al. Time-of-day effect on cardiac responses to progressive exercise . Chronobiol Int 2011;28:611–16

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