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

NCT06806670 | Recruiting

• 2 other identifiers: KT LIFESTYLERC24000854 - 2790615
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

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'.

Conditions

Kidney Transplant Recipients

Keywords

exercise; diet; cardiovascular risk; kidney transplant recipients; gut microbiota; lifestyle

Outcome Measures

Primary Outcomes (1)

• Cardiovascular risk reduction

  reduction of at least 1% in the cardiovascular risk score - Framingham score - over the observation time. This score estimates the risk of developing a cardiovascular event over a 10-year period and is calculated in relation to the outcome from the following identifiable variables in normal clinical practice: * Sex * Age * Systolic pressure value * Treatment for hypertension (yes/no) * Smoker (yes/no) * Diabetes (yes/no) * HDL value * Total cholesterol value

  From enrollment to the end of the treatment (3 years)

Secondary Outcomes (7)

• Renal function

  From enrollment to the end of the treatment (3 years)

• Gut microbiota analysis

  From enrollment to the end of the treatment (3 years)

• Inflammatory status

  From enrollment to the end of the treatment (3 years)

• Quality of Life (QoL)

  From enrollment to the end of the treatment (3 years)

• Adherence to the lifestyle intervention

  From enrollment to the end of the treatment (3 years)

Study Arms (2)

Group A, lifestyle intervention

EXPERIMENTAL

lifestyle intervention

Behavioral: lifestyle intervention

Group B

NO INTERVENTION

standard of care

Interventions

lifestyle intervention BEHAVIORAL

exercise and dietary counselling

Group A, lifestyle intervention

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• CNT (Centro Nazionale Trapianti): collaborator
• Azienda Unità Sanitaria Locale della Romagna: collaborator

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

RECRUITING

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Hypertension. 2003 Nov;42(5):1050-65. doi: 10.1161/01.HYP.0000102971.85504.7c. No abstract available.

  PMID: 14604997 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. Epub 2019 Oct 10.

  PMID: 31607623 BACKGROUND

• 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: 10.5500/wjt.v8.i1.13.

  PMID: 29507858 BACKGROUND

• 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 BACKGROUND

• van der Ploeg HP, Bull FC. Invest in physical activity to protect and promote health: the 2020 WHO guidelines on physical activity and sedentary behaviour. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):145. doi: 10.1186/s12966-020-01051-1.

  PMID: 33239047 BACKGROUND

• Markell MS, Armenti V, Danovitch G, Sumrani N. Hyperlipidemia and glucose intolerance in the post-renal transplant patient. J Am Soc Nephrol. 1994 Feb;4(8 Suppl):S37-47. doi: 10.1681/ASN.V48s37.

  PMID: 8193294 BACKGROUND

• Painter P. Exercise following organ transplantation: A critical part of the routine post transplant care. Ann Transplant. 2005;10(4):28-30.

  PMID: 17037085 BACKGROUND

• Seoane-Pillado MT, Pita-Fernandez S, Valdes-Canedo F, Seijo-Bestilleiro R, Pertega-Diaz S, Fernandez-Rivera C, Alonso-Hernandez A, Gonzalez-Martin C, Balboa-Barreiro V. Incidence of cardiovascular events and associated risk factors in kidney transplant patients: a competing risks survival analysis. BMC Cardiovasc Disord. 2017 Mar 7;17(1):72. doi: 10.1186/s12872-017-0505-6.

  PMID: 28270107 BACKGROUND

• Lim WH, Lok C, Kim SJ, Knoll G, Shah B, Naylor K, McArthur E, Luo B, Dixon SN, Hawley C, Ooi E, Viecelli AK, Wong G. Incidence of Major Adverse Cardiovascular Events and Cardiac Mortality in High-Risk Kidney-Only and Simultaneous Pancreas-Kidney Transplant Recipients. Kidney Int Rep. 2021 Feb 23;6(5):1423-1428. doi: 10.1016/j.ekir.2021.02.019. eCollection 2021 May. No abstract available.

  PMID: 34013120 BACKGROUND

• Regolisti G, Maggiore U, Sabatino A, Gandolfini I, Pioli S, Torino C, Aucella F, Cupisti A, Pistolesi V, Capitanini A, Caloro G, Gregorini M, Battaglia Y, Mandreoli M, Dani L, Mosconi G, Bellizzi V, Di Iorio BR, Conti P, Fiaccadori E; Gruppo di Studio "Esercizio fisico nel paziente con insufficienza renale cronica" of the Societa Italiana di Nefrologia. Correction: Interaction of healthcare staff's attitude with barriers to physical activity in hemodialysis patients: A quantitative assessment. PLoS One. 2018 Jun 20;13(6):e0198987. doi: 10.1371/journal.pone.0198987. eCollection 2018.

  PMID: 29924872 BACKGROUND

• Pang A, Lingham S, Zhao W, Leduc S, Rakel A, Sapir-Pichhadze R, Mathur S, Janaudis-Ferreira T. Physician Practice Patterns and Barriers to Counselling on Physical Activity in Solid Organ Transplant Recipients. Ann Transplant. 2018 May 22;23:345-359. doi: 10.12659/AOT.908629.

  PMID: 29784902 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Giuseppe Tarantino, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Tarantino, MD

CONTACT

0512144912; giuseppe.tarantino@aosp.bo.it

Valentina Totti, PhD

CONTACT

valentina.totti@iss.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 4, 2025
• Study Start: January 7, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: February 4, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)