Treffer: Impact of cardiac rehabilitation exercise management on improving exercise tolerance among patients with chronic heart disease using a telemetry-based biosignal measurement device: protocol for a multicentre randomised controlled trial in Japan (iCARE-MATE study).

Introduction: Cardiac rehabilitation (CR) improves the outcomes of patients with chronic heart disease. However, participation in hospital-based programs is limited, partly because of accessibility issues. Notably, most CRs are performed unsupervised at home, making it challenging for healthcare providers and patients to monitor progress accurately or provide tailored feedback. Wearable devices are increasingly used to track physical activity; however, many require smartphone operations, which can be difficult for older adults. The purpose of this study is to evaluate whether a simple telemetry system for activity tracking and feedback could improve exercise tolerance in outpatients with chronic heart disease undergoing unsupervised CR at home.
Methods and Analysis: This open-label, multicentre, randomised controlled trial will include 140 patients with cardiovascular diseases aged ≥20 years with percent of peak oxygen uptake (%peak VO2) <80%. Eligible patients will undergo a 2-4-week observation period followed by cardiopulmonary exercise testing. Participants with <3% peak VO2 change over 6 months will be randomised in a 1:1 ratio to either the intervention (device) or control (no device) group. The intervention group will use a wearable device to track daily activities and receive exercise guidance based on these data every 4 weeks. The control group will not use the device or receive feedback. The primary outcome is the 12-week change in peak VO <subscript>2</subscript> from baseline between the groups.
Ethics and Dissemination: This study was designed in accordance with the principles of the Declaration of Helsinki. Gifu University Graduate School of Medicine Ethics Committee approved this study (approval number: 2022-081), and all participants will sign an informed consent form.
Trial Registration: This study has been registered at the Japan Registry of Clinical Trials (jRCT; registration number, 1042220058; URL, https://jrct.mhlw.go.jp/en-latest-detail/jRCT1042220058; date of registration, 26 August 2022).
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Competing interests: TW has received research funding from TOKAI Corporation related to the conduct of this study. He had full access to all data and assumes responsibility for the integrity and accuracy of the analysis. No other authors have any financial or non-financial conflicts of interest to declare.