HEART: heart exercise and remote technologies: A randomized controlled trial study protocol

<p>Abstract</p> <p>Background</p> <p>Cardiovascular disease (CVD) is the leading cause of death worldwide. Cardiac rehabilitation (CR) is aimed at improving health behaviors to slow or reverse the progression of CVD disease. Exercise is a central element of CR. Technologies such as mobile phones and the Internet (mHealth) offer potential to overcome many of the psychological, physical, and geographical barriers that have been associated with lack of participation in exercise-based CR. We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD. This paper outlines the rationale and methods of the trial.</p> <p>Methods</p> <p>A single-blinded parallel two-arm randomized controlled trial is being conducted. A total of 170 people will be randomized at 1:1 ratio either to receive a mHealth CR program or usual care. Participants are identified by CR nurses from two metropolitan hospitals in Auckland, New Zealand through outpatient clinics and existing databases. Consenting participants are contacted to attend a baseline assessment. The intervention consists of a theory-based, personalized, automated package of text and video message components via participants' mobile phones and the Internet to increase exercise behavior, delivered over six months. The control group will continue with usual CR. Data collection occurs at baseline and 24 weeks (post-intervention). The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks. Secondary outcomes include post-intervention measures on self-reported physical activity (IPAQ), cardiovascular risk factors (systolic blood pressure, weight, and waist to hip ratio), health related quality of life (SF-36), and cost-effectiveness.</p> <p>Discussion</p> <p>This manuscript presents the protocol for a randomized controlled trial of a mHealth exercise-based CR program. Results of this trial will provide much needed information about physical and psychological well-being, and cost-effectiveness of an automated telecommunication intervention. If effective, this intervention has enormous potential to improve the delivery of CR and could easily be scaled up to be delivered nationally (and internationally) in a very short time, enhancing the translational aspect of this research. It also has potential to extend to comprehensive CR (nutrition advice, smoking cessation, medication adherence).</p> <p>Trial Registration</p> <p><a href="http://www.anzctr.org.au/ACTRN12611000117910.aspx">ACTRN12611000117910</a></p

Examining adherence to activity monitoring devices to improve physical activity in adults with cardiovascular disease: A systematic review

Background Activity monitoring devices are currently being used to facilitate and monitor physical activity. No prior review has examined adherence to the use of activity monitoring devices amongst adults with cardiovascular disease. Methods Literature from June 2012 to October 2017 was evaluated to examine the extent of adherence to any activity monitoring device used to collect objective physical activity data. Randomized control trials comparing usual care against the use of an activity monitoring device, in a community intervention for adults from any cardiovascular diagnostic group, were included. A systematic search of databases and clinical trials registers was conducted using Joanna Briggs Institute methodology. Results Of 10 eligible studies, two studies reported pedometer use and eight accelerometer use. Six studies addressed the primary outcome. Mean adherence was 59.1% (range 39.6% to 85.7%) at last follow-up. Studies lacked equal representation by gender (28.6% female) and age (range 42 to 82 years). Conclusion This review indicates that current research on activity monitoring devices may be overstated due to the variability in adherence. Results showed that physical activity tracking in women and in young adults have been understudied

A Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients: A Clinical Study Protocol

Funding: This work was partially supported by the Center for Innovative Care and Health Technology (ciTechcare), Polytechnic of Leiria, Portugal. The work of FV was funded by the Portuguese Foundation for Science and Technology (FCT), CEECINST/00103/2018. The funder had no role in the clinical study protocol.Introduction: Cardiovascular diseases (CVD) are the leading cause of death globally, taking an estimated 17. 9 million lives each year. Cardiac rehabilitation is shown to reduce mortality and hospital readmissions, while improving physical fitness and quality of life. Despite the recommendations and proven benefits, acceptance and adherence remain low. Mobile health (mHealth) solutions may contribute to more personalized and tailored patient recommendations according to their specific needs. This study protocol aims to assess the effectiveness of a user-friendly, comprehensive Clinical Decision Support System (CDSS) for remote patient monitoring of CVD patients, primarily on the reduction of recurrent cardiovascular events. Methods and Analysis: The study will follow a multicenter randomized controlled design involving two cardiology units in the Center Region of Portugal. Prospective CVD patients will be approached by the healthcare staff at each unit and checked for eligibility according to the predefined inclusion/exclusion criteria. The CDSS will suggest a monitoring plan for the patient, will advise the mHealth tools (apps and wearables) adapted to patient needs, and will collect data. The clinical study will start in January 2023. Discussion: The success of the mHeart.4U intervention will be a step toward the use of technological interfaces as an integrating part of CR programs. Ethics and Dissemination: The study will undergo ethical revision by the Ethics Board of the two hospital units where the study will unfold. The study was registered in ClinicalTrials.gov on 18th January 2022 with the number NCT05196802. The study findings will be published in international peer-reviewed scientific journals and encounters and in a user-friendly manner to the society.info:eu-repo/semantics/publishedVersio