Haemodynamic response to peripheral and inspiratory resistance training in patients with coronary artery disease (HEMODYRET): study protocol of a prospective, single-centre, randomised crossover trial

冠状动脉疾病患者外周和吸气阻力训练的血流动力学反应(HEMODYRET):一项前瞻性、单中心、随机交叉试验的研究方案

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Abstract

INTRODUCTION: Due to the documented benefits of peripheral resistance training (RT) and inspiratory resistance training, known as inspiratory muscle training (IMT), in patients with cardiovascular disease, both exercise forms are regularly used in cardiac rehabilitation. However, little is known about the haemodynamic responses to different intensities of dynamic RT, isometric RT, and IMT in patients with coronary artery disease (CAD). This study is designed to evaluate and compare the acute haemodynamic responses elicited by different RT and IMT modalities in patients with CAD. METHODS AND ANALYSIS: This study design is a prospective, single-centre, randomised crossover trial. A total of 20 participants with CAD will be included. All participants will undergo four different exercise training interventions: IMT, isometric wall squat training (IWS), dynamic leg press training (DLP) and isometric handgrip training (IHG). For each intervention, participants will perform two intensity modalities in randomised order: IMT (low vs high), IWS (low vs moderate), DLP (low vs high) and IHG (low vs moderate). The primary outcomes are the acute exercise-induced haemodynamic responses (esp. systolic blood pressure, pulse rate, stroke volume, cardiac output) across the different exercise training interventions, as well as the changes in haemodynamic responses during the recovery phase for each intervention. Secondary outcomes include changes in tissue oxygen saturation, oxygen saturation, and perceived dyspnoea and exertion. The study period is planned for 2025. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the German Sport University Cologne (Ethical Approval Code: 209/24). The findings will be disseminated through international peer-reviewed publications. This study is supported by the Alexander von Humboldt Foundation via the partnership with the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)(CAPES-Humboldt Research Fellowship for Experienced Researchers) and by research funding from Edwards Lifesciences LLC (Limited Liability Company). TRIAL REGISTRATION NUMBER: German Clinical Trials Register DRKS00035668.

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