Actively Recruiting

Phase Not Applicable
Age: 30Years - 69Years
All Genders
ID06806670

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-04

275

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

I

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead Sponsor

C

CNT (Centro Nazionale Trapianti)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to determine if tailored exercise combined with dietary counselling can reduce cardiovascular risk in adult kidney transplant recipients compared to standard care over a 3-year observation period. The study also explores how lifestyle changes may affect kidney function, quality of life, gut microbiota, inflammatory markers, and cardiovascular biomarkers in this patient group. Participants are randomly assigned to one of two groups: the intervention group receives a personalized exercise program along with specific dietary counselling, while the control group receives general advice on healthy lifestyles without tailored prescriptions. Throughout the study, researchers will monitor several health indicators including cardiovascular risk scores, kidney function, gut microbiota composition, inflammatory and cardiovascular biomarkers, and quality of life. Participants will be followed for three years during which they will undergo regular assessments of their health status, biomarkers, and lifestyle adherence. The study will also track hospital admissions, cardiovascular events, and mortality. Data on the cost-effectiveness of the lifestyle intervention will be collected, and participants' overall wellbeing and biological markers will be measured to evaluate the impact of the interventions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 30Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically stabilized male and female kidney transplant patients
  • Aged between 30 and 69 years
  • Transplantation occurred from 6 months to 10 years ago with clinical stability
  • Kidney function with eGFR (CKD-EPI formula) of at least 30 mL/min/1.73m²
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Unable to follow the prescribed exercise and dietary program
  • Recent acute cardiovascular event within the past 2 months
  • Unstable angina
  • Uncontrolled hyperkinetic or hypokinetic arrhythmias with signs of hemodynamic impairment
  • Severe aortic stenosis
  • Heart failure NYHA class III-IV with ejection fraction less than 40%
  • Acute illnesses limiting physical activity
  • Severe hypertension with blood pressure 200/110 mm Hg or higher
  • Neuro-musculo-skeletal conditions worsened by exercise
  • Unwilling to change lifestyle
  • Substance abuse, psychiatric disorders, or conditions complicating communication
  • Pregnant women

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 years

Participants receive a lifestyle intervention consisting of tailored exercise and dietary counselling or standard healthy lifestyle advice, with assessments of cardiovascular risk, kidney function, gut microbiota, inflammatory markers, and quality of life over time.

Regular visits throughout the treatment period

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, Italy, 40138

Actively Recruiting

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Research Team

G

Giuseppe Tarantino, MD

V

Valentina Totti, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention.

Mark J Sarnak, Andrew S Levey, Anton C Schoolwerth...

https://pubmed.ncbi.nlm.nih.gov/14604997

Physical Condition, Glycemia, Liver Function, and Quality of Life in Liver Transplant Recipients After a 12-Month Supervised Exercise Program.

Valentina Totti, Mariarosa Tamè, Patrizia Burra...

https://pubmed.ncbi.nlm.nih.gov/31607623

Invest in physical activity to protect and promote health: the 2020 WHO guidelines on physical activity and sedentary behaviour.

Hidde P van der Ploeg, Fiona C Bull

https://pubmed.ncbi.nlm.nih.gov/33239047