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

Recruiting now · Not applicable

Conditions studied: Kidney Transplant Recipients

In brief

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'.

Key facts

Study ID

NCT06806670

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

275

Starts

2025-01-07

Expected to finish

2031-01-01

Last updated by the study team

2025-02-04

Who can join

Age: 30 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, BO, Italy (enrolling)

Full record on ClinicalTrials.gov

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