RecruitingNot ApplicableNCT06806670

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

275 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

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'.


Eligibility

Min Age: 30 YearsMax Age: 69 Years

Inclusion Criteria6

  • 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 Criteria12

  • 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.

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Interventions

BEHAVIORALlifestyle intervention

exercise and dietary counselling


Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, Italy

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NCT06806670


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