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

IRCCS Azienda Ospedaliero-Universitaria di Bologna275 enrolled

Overview

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'.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

275

Conditions

Kidney Transplant Recipients

Interventions

lifestyle interventionBEHAVIORAL

exercise and dietary counselling

Eligibility

Sex: ALLMin age: 30 YearsMax age: 69 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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; * Organ function: eGFR (CKD-EPI formula) ≥ 30 mL/min/1.73m ;2 * Obtaining informed consent; Exclusion Criteria: * 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, * Severe aortic stenosis, * Heart failure NYHA class III-IV, FE \< 40%, * Acute illnesses that limit physical activity, * Severe hypertension (basal BP ≥200/110 mm Hg), * Neuro-musculo-skeletal pathologies that may be aggravated by exercise, * Patients unwilling to change lifestyle; * Any form of substance abuse, psychiatric disorder or condition that, according to the investigator, can complicate communication between doctor and patient; * Pregnant women.

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, Italy

RECRUITING

Outcomes

Primary Outcomes

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