Lifestyle intervention to reduce cardiovascular risk in kidney transplant recipients: the KT-LIFESTYLE multicentre randomized controlled trial

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Background: Kidney transplant recipients remain at high cardiovascular risk despite improved graft and patient survival. Physical inactivity, weight gain, and suboptimal dietary habits are common after transplantation and may contribute to this burden. Methods: The KT-LIFESTYLE trial is a pragmatic, multicentre, prospective, open-label randomized controlled study designed to evaluate whether a structured lifestyle intervention can reduce cardiovascular risk in kidney transplant recipients. Participants will be randomized 1:1 to individualized exercise prescription plus tailored dietary counselling or standard lifestyle advice. The intervention combines multidisciplinary assessment, individualized exercise programming, motivational interviewing, and nutritional counselling integrated into routine transplant follow-up. The primary endpoint is the change in 10-year cardiovascular risk, assessed by the Framingham score over 36 months. Secondary outcomes include renal function estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 equation estimated glomerular filtration rate, body composition, inflammatory markers, gut microbiota composition, health-related quality of life, adherence to physical activity and dietary counselling, hospital admissions, major adverse cardiovascular events, and all-cause mortality. Conclusions: KT-LIFESTYLE aims to provide evidence on the effectiveness and feasibility of a long-term lifestyle intervention after kidney transplantation. The study may also clarify the mechanisms through which lifestyle modification influences cardiovascular risk, inflammation, body composition, and gut microbiota in this population.Clinical trials registration number: NCT06806670.

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