Mild renal insufficiency is associated with increased cardiovascular mortality: The Hoorn Study.
Ronald M A Henry, Piet J Kostense, Griët Bos...
https://pubmed.ncbi.nlm.nih.gov/12234312/Actively Recruiting
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-04
275
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Exercise and Diet Effects in Reducing Cardiovascular Risk in Kidney Transplant Recipients
G
Giuseppe Tarantino, MD
V
Valentina Totti, PhD
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead Sponsor
CNT (Centro Nazionale Trapianti)
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
CNT (Centro Nazionale Trapianti)
Collaborating Sponsor