Hybrid cardiac rehabilitation trial (HYCARET): protocol of a randomised, multicentre, non-inferiority trial in South America

Pamela Serón, Maria J Oliveros, Gabriel N Marzuca-Nassr, Fernando Lanas, Gladys Morales, Claudia Román, Sergio R Muñoz, Nicolás Saavedra, Sherry L Grace, Pamela Serón, Maria J Oliveros, Gabriel N Marzuca-Nassr, Fernando Lanas, Gladys Morales, Claudia Román, Sergio R Muñoz, Nicolás Saavedra, Sherry L Grace

Abstract

Introduction: Cardiac rehabilitation (CR) programmes are well established, and their effectiveness and cost-effectiveness are proven. In spite of this, CR remains underused, especially in lower-resource settings such as Latin America. There is an urgent need to create more accessible CR delivery models to reach all patients in need. This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid CR programme compared with a standard programme.

Method and analysis: A non-inferiority, pragmatic, multicentre, parallel (1:1), prospective, randomised and open with blinded endpoint assessment clinical trial will be conducted. 308 patients with coronary artery disease will be recruited consecutively. Participants will be randomised to hybrid or standard rehabilitation programme. The hybrid CR programme includes 10 supervised exercise sessions and individualised lifestyle counselling by a physiotherapist, with a transition after 4-6 weeks to unsupervised delivery via text messages and phone calls. The standard CR consists of 18-22 supervised exercise sessions, as well as group education sessions about lifestyle. Intervention in both groups is between 8 and 12 weeks. The primary outcome is a composite of cardiovascular mortality and hospitalisations due to cardiovascular causes. Secondary outcomes are health-related quality of life, exercise capacity, muscle strength, heart-healthy behaviour, return-to-work, cardiovascular risk factor, adherence, and exercise-related adverse events. The outcomes will be measured at the end of intervention, at 6 months and at 12 months follow-up from recruitment. The primary outcome will be tracked through the end of the trial. Per-protocol and intention-to-treat analysis will be undertaken.Cox regression model will be used to compare primary outcome among study groups.

Ethics and dissemination: Ethics committees at the sponsor institution and each centre where participants will be recruited approved the study protocol and the Informed Consent. Research findings will be published in peer-reviewed journals; additionally, results will be disseminated among region stakeholders.

Trial registration number: NCT03881150; Pre-results.

Date and version: 01 October 2019.

Keywords: Cardiac Rehabilitation; Coronary Disease; Exercise; Telerehabilitation.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart, activities and timeline expected of the trial. CR, cardiac rehabilitation; HYCARET, Hybrid Cardiac Rehabilitation Trial.
Figure 2
Figure 2
Possible scenarios of observed intervention differences with sample size calculation. d= non-inferiority limit.

References

    1. Abate D, Abate KH, et al. , GBD 2017 DALYs and HALE Collaborators . Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2017: a systematic analysis for the global burden of disease study 2017. Lancet 2018;392:1859–922. 10.1016/S0140-6736(18)32335-3
    1. Gattini C, Ruiz P, Riera C, et al. . Salud en Sudamérica: Panorama de la situación de salud Y de las políticas Y sistemas de salud Equipo técnico de OPS/OMS que preparó El documento: Autores principales Y coordinación: Contribuyentes. Washington, 2012.
    1. University of Washington The Institute for Health Metrics and Evaluation (IHME). University of Washington. [Internet]. Available:
    1. Smith SC, Benjamin EJ, Bonow RO, et al. . AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update. Circulation 2011;124:2458–73. 10.1161/CIR.0b013e318235eb4d
    1. Teo K, Lear S, Islam S, et al. . Prevalence of a healthy lifestyle among individuals with cardiovascular disease in high-, middle- and low-income countries. JAMA 2013;309 10.1001/jama.2013.3519
    1. Nazzal C, Lanas F, Bugueño C, et al. . Prevención secundaria post infarto agudo de miocardio en hospitales públicos: implementación y resultados de las garantías GES TT - Universal health coverage and accomplishment of secondary prevention goals among patients with acute myocardial infarction. Rev Med Chil 2013;141:977–86.
    1. O’Gara PT, Kushner FG, Ascheim DD, et al. . ACCF/AHA guideline for the management of ST-elevation myocardial infarction. Circulation 2013;2012.
    1. Thomas RJ, King M, Lui K, et al. . AACVPR/ACC/AHA 2007 performance measures on cardiac rehabilitation for referral to and delivery of cardiac Rehabilitation/Secondary prevention services. Circulation 2007;116:1611–42.
    1. Anderson L, Thompson DR, Oldridge N, et al. . Exercise-based cardiac rehabilitation for coronary heart disease. Taylor RS, editor. Cochrane Database Syst Rev 2016;1.
    1. Francis T, Kabboul N, Rac V, et al. . The effect of cardiac rehabilitation on health-related quality of life in patients with coronary artery disease: a meta-analysis. Can J Cardiol 2019;35:352–64. 10.1016/j.cjca.2018.11.013
    1. Wong WP, Feng J, Pwee KH, et al. . A systematic review of economic evaluations of cardiac rehabilitation. BMC Health Serv Res 2012;12:1 10.1186/1472-6963-12-243
    1. Oldridge NB, Pakosh MT, Thomas RJ. Cardiac rehabilitation in low- and middle-income countries: a review on cost and cost-effectiveness. Int Health 2016;8:77–82. 10.1093/inthealth/ihv047
    1. Shields GE, Wells A, Doherty P, et al. . Cost-Effectiveness of cardiac rehabilitation: a systematic review. Heart 2018;104:1403–10. 10.1136/heartjnl-2017-312809
    1. Harrison RW, Simon D, Miller AL, et al. . Association of hospital myocardial infarction volume with adherence to American College of Cardiology/American heart association performance measures: insights from the National cardiovascular data registry. Am Heart J 2016;178:95–101. 10.1016/j.ahj.2016.04.002
    1. Turk-Adawi K, Supervia M, Lopez-Jimenez F, et al. . Cardiac rehabilitation availability and density around the globe. EClinicalMedicine 2019;13:31–45. 10.1016/j.eclinm.2019.06.007
    1. Moghei M, Turk-Adawi K, Isaranuwatchai W, et al. . Cardiac rehabilitation costs. Int J Cardiol 2017;244:322–8. 10.1016/j.ijcard.2017.06.030
    1. Grace SL, Turk-Adawi KI, Contractor A, et al. . Cardiac rehabilitation delivery model for low-resource settings: an international Council of cardiovascular prevention and rehabilitation consensus statement. Prog Cardiovasc Dis 2016;59:303–22. 10.1016/j.pcad.2016.08.004
    1. Clark RA, Conway A, Poulsen V, et al. . Alternative models of cardiac rehabilitation: a systematic review. Eur J Prev Cardiol 2015;22:35–74. 10.1177/2047487313501093
    1. Thomas RJ, Beatty AL, Beckie TM, et al. . Home-Based cardiac rehabilitation: a scientific statement from the American association of cardiovascular and pulmonary rehabilitation, the American heart association, and the American College of cardiology. Circulation 2019;140 10.1161/CIR.0000000000000663
    1. Huang K, Liu W, He D, et al. . Telehealth interventions versus Center-Based cardiac rehabilitation of coronary artery disease: a systematic review and meta-analysis. Eur J Prev Cardiol 2015;22:959–71. 10.1177/2047487314561168
    1. Rawstorn JC, Gant N, Direito A, et al. . Telehealth exercise-based cardiac rehabilitation: a systematic review and meta-analysis. Heart 2016;102:1183–92. 10.1136/heartjnl-2015-308966
    1. Kraal JJ, Van den Akker-Van Marle ME, Abu-Hanna A, et al. . Clinical and cost-effectiveness of home-based cardiac rehabilitation compared to conventional, centre-based cardiac rehabilitation: Results of the FIT@Home study. Eur J Prev Cardiol 2017;24:1260–73. 10.1177/2047487317710803
    1. Whittaker F, Wade V. The costs and benefits of technology-enabled, home-based cardiac rehabilitation measured in a randomised controlled trial. J Telemed Telecare 2014;20:419–22. 10.1177/1357633X14552376
    1. Pfaeffli Dale L, Whittaker R, Dixon R, et al. . Acceptability of a mobile health exercise-based cardiac rehabilitation intervention: a randomized trial. J Cardiopulm Rehabil Prev 2015;35:312–9. 10.1097/HCR.0000000000000125
    1. Varnfield M, Karunanithi M, Lee C-K, et al. . Smartphone-Based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: results from a randomised controlled trial. Heart 2014;100:1770–9. 10.1136/heartjnl-2014-305783
    1. Grace SL, Turk-Adawi KI, Contractor A, et al. . Cardiac rehabilitation delivery model for low-resource settings. Heart 2016;102:1449–55. 10.1136/heartjnl-2015-309209
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200 10.7326/0003-4819-158-3-201302050-00583
    1. Sealed Envelope Ltd Power calculator for binary outcome non-inferiority trial. [Internet], 2012. Available: [Accessed 10 Aug 2019].
    1. Borg GAV. Borg’s Perceived Exertion and Pain Scales. Champaign, IL: Human Kinetics, 1998.
    1. Redfern J, Thiagalingam A, Jan S, et al. . Development of a set of mobile phone text messages designed for prevention of recurrent cardiovascular events. Eur J Prev Cardiol 2014;21:492–9. 10.1177/2047487312449416
    1. O'Gara PT, Kushner FG, Ascheim DD, et al. . 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction. J Am Coll Cardiol 2013;61:e78–140. 10.1016/j.jacc.2012.11.019
    1. Perk J, De Backer G, Gohlke H, et al. . European guidelines on cardiovascular disease prevention in clinical practice (version 2012) the fifth joint Task force of the European Society of cardiology. Eur Heart J 2012;33:1635–701.
    1. Oldridge N, Hö Fer S, Mcgee H, et al. . The HeartQoL: Part II. validation of a new core health-related quality of life questionnaire for patients with ischemic heart disease 2012.
    1. Zarate V, Kind P, Valenzuela P, et al. . Social valuation of EQ-5D health states: the Chilean case. Value in Health 2011;14:1135–41. 10.1016/j.jval.2011.09.002
    1. Crapo RO, Casaburi R, Coates AL, et al. . Ats statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002;166:111–7.
    1. Leong DP, Teo KK, Rangarajan S, et al. . Prognostic value of grip strength : fi ndings from the Prospective Urban Rural Epidemiology (PURE) study. Lancet 2015;6736:1–8.
    1. Roberts HC, Denison HJ, Martin HJ, et al. . A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing 2011;40:423–9. 10.1093/ageing/afr051
    1. Craig CL, Marshall AL, Sjöström M, et al. . International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003;35:1381–95. 10.1249/01.MSS.0000078924.61453.FB
    1. Serón P, Muñoz S, Lanas F. Nivel de actividad física medida a través del cuestionario Internacional de actividad física en población chilena levels of physical activity in an urban population from Temuco, Chile. artículo Investig rev Med chile 2010;138:1232–9.
    1. Echeverría G, Urquiaga I, Concha MJ, et al. . Validación de cuestionario autoaplicable para un índice de alimentación mediterránea en Chile. Rev. méd. Chile 2016;144:1531–43. 10.4067/S0034-98872016001200004
    1. Pickering TG, Hall JE, Appel LJ, et al. . Recommendations for blood pressure measurement in humans and experimental animals. Circulation 2005;111:697–716. 10.1161/01.CIR.0000154900.76284.F6
    1. Walker E, Nowacki AS. Understanding equivalence and Noninferiority testing. J Gen Intern Med 2011;26:192–6. 10.1007/s11606-010-1513-8
    1. KKG L, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983;70:659–63.
    1. Bratton DJ, Williams HC, Kahan BC, et al. . When inferiority meets non-inferiority: implications for interim analyses. Clinical Trials 2012;9:605–9. 10.1177/1740774512453220
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Harris PA, Taylor R, Minor BL, et al. . The REDCap Consortium: building an international community of software platform partners. J Biomed Inform 2019;95:103208 10.1016/j.jbi.2019.103208
    1. World Health Organization Handbook for good clinical research practice (GCP): guidance for implementation. Geneva, 2005.
    1. Schulz KF, Altman DG, Moher D, et al. . Consort 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332–702. 10.1136/bmj.c332
    1. Boutron I, Altman DG, Moher D, et al. . Consort statement for randomized trials of nonpharmacologic treatments: a 2017 update and a consort extension for nonpharmacologic trial Abstracts. Ann Intern Med 2017;167:40 10.7326/M17-0046
    1. Piaggio G, Elbourne DR, Pocock SJ, et al. . Consort group for the. reporting of Noninferiority and equivalence randomized trials. JAMA 2012;308.
    1. Zwarenstein M, Treweek S, Gagnier JJ, et al. . Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390 10.1136/bmj.a2390
    1. International Committee of Medical Journal Editors Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals, 2017. Available:
    1. Riebe D, Franklin BA, Thompson PD, et al. . Updating ACSM's recommendations for exercise Preparticipation health screening. Med Sci Sports Exerc 2015;47:2473–9. 10.1249/MSS.0000000000000664
    1. Schwarzer R. Modeling health behavior change: how to predict and modify the adoption and maintenance of health behaviors. Appl Psychol 2008;57:1–29. 10.1111/j.1464-0597.2007.00325.x

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다