Clinical trial NCT06806670: Exercise and Diet Effects in Reducing Cardiovascular Risk in Kidney Transplant Recipients
Official title: Effects of Exercise and Dietary Counselling in Reducing the Cardiovascular Risk Score in Kidney Transplant Patients: KT- LIFESTYLE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplant Recipients
Keywords: exercise
diet
cardiovascular risk
kidney transplant recipients
gut microbiota
lifestyle
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: CNT (Centro Nazionale Trapianti)
name: Azienda Unità Sanitaria Locale della Romagna
First posted: 2025-02-04
Enrollment: 275
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiovascular risk reduction
timeFrame: From enrollment to the end of the treatment (3 years)
Secondary outcomes:
measure: Renal function
timeFrame: From enrollment to the end of the treatment (3 years)
measure: Gut microbiota analysis
timeFrame: From enrollment to the end of the treatment (3 years)
measure: Inflammatory status
timeFrame: From enrollment to the end of the treatment (3 years)
measure: Quality of Life (QoL)
timeFrame: From enrollment to the end of the treatment (3 years)
measure: Adherence to the lifestyle intervention
timeFrame: From enrollment to the end of the treatment (3 years)
measure: Cost-effectiveness of a healthy lifestyle intervention
timeFrame: From enrollment to the end of the treatment (3 years)
measure: Cardiovascular biomarkers
timeFrame: From enrollment to the end of the treatment (3 years)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Giuseppe Tarantino, MD
role: PRINCIPAL_INVESTIGATOR
References:
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