Effects of exercise and diet on cardiovascular risk in kidney transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the impact of a tailored exercise program combined with dietary counseling on reducing cardiovascular risk in kidney transplant recipients over a three-year period. Participants will be randomized into two groups: one receiving personalized lifestyle interventions and the other following standard care. The study will assess changes in cardiovascular risk scores, kidney function, quality of life, and gut microbiota, alongside monitoring hospital admissions and major cardiovascular events. The goal is to determine the effectiveness of lifestyle modifications in improving health outcomes for this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Bo, Italy Recruiting

Study contacts

• Principal investigator: Giuseppe Tarantino, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Giuseppe Tarantino, MD
• Email: giuseppe.tarantino@aosp.bo.it
• Phone: 0512144912

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.