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
IRCCS Azienda Ospedaliero-Universitaria di Bologna
275 participants
Jan 7, 2025
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
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
exercise and dietary counselling
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06806670