Comparison of telehealth and supervised phase III cardiac rehabilitation in regional Australia: protocol for a non-inferiority trial.

Introduction: Exercise-based cardiac rehabilitation programmes (ExCRP) promote recovery and secondary prevention for individuals with cardiovascular disease (CVD). Despite this, enrolment and adherence to ExCRP in rural locations is low. Telehealth programmes provide a convenient, home-based intervention, but concerns remain about compliance to exercise prescription. This paper presents the rationale and protocol design to determine if telehealth delivered ExCRP is not inferior to supervised ExCRP for improving cardiovascular function and exercise fidelity.
Method and Analysis: A non-inferiority, parallel (1:1), single-blinded randomised clinical trial will be conducted. Fifty patients with CVD will be recruited from a rural phase II ExCRP. Participants will be randomly assigned to telehealth or supervised ExCRP and prescribed three weekly exercise sessions for 6 weeks. Exercise sessions will include a 10 min warm up, up to 30 min of continuous aerobic exercise at a workload equivalent to the ventilatory anaerobic threshold and a 10 min cool down. The primary outcome will be change in cardiorespiratory fitness as measured by cardiopulmonary exercise test. Secondary outcome measures will include change in blood lipid profile, heart rate variability, pulse wave velocity, actigraphy measured sleep quality and training fidelity. Non-inferiority will be confirmed if intention-to-treat and per-protocol analyses conclude the same outcome following independent samples t-test with p<0.025.
Ethics and Dissemination: Research ethics committees at La Trobe University, St John of God Health Care and Bendigo Health approved the study protocol and informed consent. Findings will be published in peer-reviewed journals and disseminated among stakeholders.
Trial Registration Number: ACTRN12622000872730p; pre-results.
Competing Interests: Competing interests: None declared.
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