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

Effects of Exercise and Dietary Counselling in Reducing the Cardiovascular Risk Score in Kidney Transplant Patients: KT- LIFESTYLE Study

This study is testing if a personalized exercise and diet program can help kidney transplant patients lower their risk of heart problems over three years compared to standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 275 (estimated)
• Ages: 30 Years to 69 Years
• Sex: All
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (other)
• Locations: 1 site (Bologna, BO)
• Trial ID: NCT06806670 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are clinically stabilized kidney transplant recipients aged 30 to 69 years, with stable organ function and at least six months post-transplant.

Not a fit: Patients with recent acute cardiovascular events, severe hypertension, or other significant health issues that limit physical activity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce cardiovascular risk and improve overall health in kidney transplant recipients.

How similar studies have performed: Other studies have shown promising results with lifestyle interventions in similar populations, indicating potential for success in this approach.

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.

Where this trial is running

Bologna, BO

• 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

Conditions: Kidney Transplant Recipients, exercise, diet, cardiovascular risk, kidney transplant recipients, gut microbiota, lifestyle