Exercise and Diet Effects in Reducing Cardiovascular Risk in Kidney Transplant Recipients
NCT ID: NCT06806670
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
275 participants
INTERVENTIONAL
2025-01-07
2031-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dietary Intervention Trial Targeting Metabolic Syndrome After Kidney Transplantation
NCT04698408
Home-based Exercise in Renal Transplant Recipients
NCT04123951
Smart and Fit for Kidney Transplantation
NCT06040281
Outcomes of a Pre-operative Exercise Programme for Live Donor and Recipient Kidney Transplant Patients
NCT06858098
Structured Program of Exercise for Recipients of Kidney Transplantation
NCT04954690
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A, lifestyle intervention
lifestyle intervention
lifestyle intervention
exercise and dietary counselling
Group B
standard of care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
lifestyle intervention
exercise and dietary counselling
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
30 Years
69 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CNT (Centro Nazionale Trapianti)
UNKNOWN
Azienda Unità Sanitaria Locale della Romagna
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giuseppe Tarantino, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, BO, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Painter P. Exercise following organ transplantation: A critical part of the routine post transplant care. Ann Transplant. 2005;10(4):28-30.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC24000854 - 2790615
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KT LIFESTYLE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.