TY - JOUR T1 - Effect of a personalised mHealth home-based training application on physical activity levels during and after centre-based cardiac rehabilitation: rationale and design of the Cardiac RehApp randomised control trial JF - BMJ Open Sport & Exercise Medicine JO - BMJ OPEN SP EX MED DO - 10.1136/bmjsem-2021-001159 VL - 7 IS - 3 SP - e001159 AU - Thijs Vonk AU - Esmee A Bakker AU - Erwin S Zegers AU - Maria T E Hopman AU - Thijs M H Eijsvogels Y1 - 2021/09/01 UR - http://bmjopensem.bmj.com/content/7/3/e001159.abstract N2 - Many patients lapse into a physically inactive lifestyle within months after cardiac rehabilitation (CR) programme completion. A mobile-health (mHealth) home-based training application can be used to intensify and/or prolong the CR programme to induce long-lasting improvements of habitual physical activity levels. This study will assess the effect of an additional home-based training module during CR and post-CR on habitual physical activity levels among coronary artery disease patients. A total of 132 patients (>18 years old) will be recruited in an 18-week randomised controlled trial with four arms: (1) 6 weeks centre-based CR (ie, standard care), (2) 6 weeks combined centre-based+mHealth home-based CR, (3) 6 weeks centre-based CR followed by 12 weeks mHealth home-based CR, (4) 6 weeks combined centre-based+mHealth home-based CR followed by 12 weeks mHealth home-based CR. The intervention groups will receive a daily and personalised exercise training using a smartphone application (Virtual Training) in addition to and/or as extension of the centre-based CR programme. The participants will be assessed prior to the centre-based CR programme, after completion of the 6-week CR programme and after the 12 weeks extension. Primary outcome will be objectively measured habitual physical activity levels expressed as moderate to vigorous intensity activities (min/week). Secondary outcome parameters include sedentary behaviour, physical fitness (estimated VO2max), handgrip strength, cardiovascular risk profile, quality of life and cardiac anxiety scores. The findings of the Cardiac RehApp study will provide insight into the added value of a personalised mHealth home-based training application on physical activity levels during and after centre-based CR. Trial registration number: NL72182.091.019.Data are available upon reasonable request. All data will be stored in the Digital Research Environment (www.andrea-consortium.org), an online and easy-to-use cloud platform which allows users across the globe to merge, analyse, store, share, archive and publish data in a safe and compliant way (ie, security, ICT infrastructure, audit trail, GDPR compliant). Standard software packages are available for data handling and statistical analyses (eg, SPSS, R, SAS). In line with the Open Science initiative and the FAIR principles (Findable, Accessible, Interoperable and Reusable), data from the Cardiac RehApp study will be available for reuse upon reasonable request via the corresponding author. ER -