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

Официальное название

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

Обзор

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'.

Подробное описание

The main questions it aims to answer are:

* Prescribed exercise and dietary counselling could reduce of at least 1% in the cardiovascular risk score (by Framingham score) and cardiovascular biomarkers in kidney transplant recipients? * How much can a lifestyle intervention affect kidney function, quality of life and the gut microbiota in this patient population?

Researchers will compare kidney transplant recipients undergoing tailored exercise combined with dietary counselling compared to a group of patients following the 'standard of care' to see if there is a reduction in cardiovascular risk, BMI, inflammatory markers, improve of gut microbiota and perception of quality of life. In addition, a number of hospital admissions for important clinical events, the number of fatal and non-fatal cardiovascular events (MACE), and mortality from all causes will be assessed in the long term.

Participants will enroll from the Nephrology, Dialysis and Transplant Units and randomize in intervantion group (A) or control (B).

In group A/intervention, a tailored exercise programme combined with specific dietary counselling will be prescribed, in group B/control, generic advice on healthy lifestyles will be given (standard of care) without specific prescription.

In all patients, quality of life, gut microbiota, inflammatory and cardiovascular biomarkers (Framingham score, BNP, etc.), lipid profile and renal function over time will be assessed.

Вмешательства

• Поведенческое lifestyle intervention
  exercise and dietary counselling

Первичные конечные точки

• Cardiovascular risk reduction [Срок оценки: From enrollment to the end of the treatment (3 years)]

Вторичные конечные точки (7)

• Renal function [Срок оценки: From enrollment to the end of the treatment (3 years)]
• Gut microbiota analysis [Срок оценки: From enrollment to the end of the treatment (3 years)]
• Inflammatory status [Срок оценки: From enrollment to the end of the treatment (3 years)]
• Quality of Life (QoL) [Срок оценки: From enrollment to the end of the treatment (3 years)]
• Adherence to the lifestyle intervention [Срок оценки: From enrollment to the end of the treatment (3 years)]
• Cost-effectiveness of a healthy lifestyle intervention [Срок оценки: From enrollment to the end of the treatment (3 years)]
• Cardiovascular biomarkers [Срок оценки: From enrollment to the end of the treatment (3 years)]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

Публикации

• de Padua Netto MV, Bonfim TC, Costa EN, de Lima HV, Netto LC. Cardiovascular risk estimated in renal transplant recipients with the Framingham score. Transplant Proc. 2012 Oct;44(8):2337-40. doi: 10.1016/j.transproceed.2012.07.054. PMID 23026587
• Henry RM, Kostense PJ, Bos G, Dekker JM, Nijpels G, Heine RJ, Bouter LM, Stehouwer CD. Mild renal insufficiency is associated with increased cardiovascular mortality: The Hoorn Study. Kidney Int. 2002 Oct;62(4):1402-7. doi: 10.1111/j.1523-1755.2002.kid571.x. PMID 12234312
• Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA, Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular diseas PMID 14604997
• Totti V, Fernhall B, Di Michele R, Todeschini P, La Manna G, Cappuccilli M, Angelini ML, De Fabritiis M, Merni F, Benedetti E, Roi GS, Nanni Costa A, Mosconi G. Longitudinal Analysis of Cardiovascular Risk Factors in Active and Sedentary Kidney Transplant Recipients. Medicina (Kaunas). 2020 Apr 16;56(4):183. doi: 10.3390/medicina56040183. PMID 32316125
• Masiero L, Puoti F, Bellis L, Lombardini L, Totti V, Angelini ML, Spazzoli A, Nanni Costa A, Cardillo M, Sella G, Mosconi G. Physical activity and renal function in the Italian kidney transplant population. Ren Fail. 2020 Nov 10;42(1):1192-1204. doi: 10.1080/0886022X.2020.1847723. PMID 33256487
• Totti V, Tame M, Burra P, Mosconi G, Roi GS, Sella G, Ermolao A, Ferrarese A, Sgarzi S, Savino G, Parodi G, Poggioli G, Ricchiuti A, Di Michele R, Trerotola M, Nanni Costa A. Physical Condition, Glycemia, Liver Function, and Quality of Life in Liver Transplant Recipients After a 12-Month Supervised Exercise Program. Transplant Proc. 2019 Nov;51(9):2952-2957. doi: 10.1016/j.transproceed.2019.03.087 PMID 31607623
• Roi GS, Mosconi G, Totti V, Angelini ML, Brugin E, Sarto P, Merlo L, Sgarzi S, Stancari M, Todeschini P, La Manna G, Ermolao A, Tripi F, Andreoli L, Sella G, Anedda A, Stefani L, Galanti G, Di Michele R, Merni F, Trerotola M, Storani D, Nanni Costa A. Renal function and physical fitness after 12-mo supervised training in kidney transplant recipients. World J Transplant. 2018 Feb 24;8(1):13-22. doi PMID 29507858
• Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8. PMID 22818941

Идентификаторы

NCT: NCT06806670 · KT LIFESTYLE · RC24000854 - 2790615

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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