NCT06806670

Exercise and Diet Effects in Reducing Cardiovascular Risk in Kidney Transplant Recipients

Effects of Exercise and Dietary Counselling in Reducing the Cardiovascular Risk Score in Kidney Transplant Patients: KT- LIFESTYLE Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 30 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess whether, over an observation period of 3 years, there is a reduction in cardiovascular risk, and the extent of this reduction, in a group of adult kidney transplant patients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care'.

Detailed description

The main questions it aims to answer are: * Prescribed exercise and dietary counselling could reduce of at least 1% in the cardiovascular risk score (by Framingham score) and cardiovascular biomarkers in kidney transplant recipients? * How much can a lifestyle intervention affect kidney function, quality of life and the gut microbiota in this patient population? Researchers will compare kidney transplant recipients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care' to see if there is a reduction in cardiovascular risk, BMI, inflammatory markers, improve of gut microbiota and perception of quality of life. In addition, a number of hospital admissions for important clinical events, the number of fatal and non-fatal cardiovascular events (MACE), and mortality from all causes will be assessed in the long term. Participants will enroll from the Nephrology, Dialysis and Transplant Units and randomize in intervantion group (A) or control (B). In group A/intervention, a tailored exercise programme combined with specific dietary counselling will be prescribed, in group B/control, generic advice on healthy lifestyles will be given (standard of care) without specific prescription. In all patients, quality of life, gut microbiota, inflammatory and cardiovascular biomarkers (Framingham score, BNP, etc.), lipid profile and renal function over time will be assessed.

Conditions

• Kidney Transplant Recipients

Interventions

Type	Name	Description
BEHAVIORAL	lifestyle intervention	exercise and dietary counselling

Timeline

• Start date: 2025-01-07
• Primary completion: 2030-01-01
• Completion: 2031-01-01
• First posted: 2025-02-04
• Last updated: 2025-02-04

Locations

1 site across 1 country: Italy