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'.
Clinically stabilised male and female kidney transplant patients (assessment by the referring transplant centre)
Minimum age, 30 years;
Maximum age, 69 years;
Period since transplantation: from 6 months (subject to clinical stability being achieved) to 10 years;
Patients unable to follow the prescription,
Recent acute cardiovascular event (< 2 months),
Unstable angina,
Hyperkinetic/hypokinetic arrhythmias not controlled by therapy, and with signs of haemodynamic impairment,
Parallel
lifestyle intervention
Behavioralexercise and dietary counselling
Cardiovascular risk reduction
reduction of at least 1% in the cardiovascular risk score - Framingham score - over the observation time. This score estimates the risk of developing a cardiovascular event over a 10-year period and is calculated in relation to the outcome from the following identifiable variables in normal clinical practice: * Sex * Age * Systolic pressure value * Treatment for hypertension (yes/no) * Smoker (yes/no) * Diabetes (yes/no) * HDL value * Total cholesterol value
Renal function
The trend of renal function assess by eGFR using the CKD-EPI formula
Gut microbiota analysis
The relative abundances of the main intestinal bacterial groups and hence the effect of physical exercise on the gut microbiota
Inflammatory status
The variation of the inflammatory status (by CRP analysis, IL-6, ferritin, cortisol)
Quality of Life (QoL)
The perception of quality of life through the SF12 questionnaire (composite items of physical and mental health)
Click on the lead sponsor to view all of their trials.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead sponsor
CNT (Centro Nazionale Trapianti)
Collaborator
Azienda Unità Sanitaria Locale della Romagna
Collaborator
