Exercise training in kidney transplant recipients (EXTRA Trial): protocol for a randomized controlled trial
12 affiliations
- 1Department of Exercise Sciences and Physiology, Graduate Program in Physical Education, Catholic University of Brasília, Brasília, Distrito Federal, Brazil
- 2Laboratory for Science and Innovation Applied to Pathophysiology and Exercise, Catholic University of Brasília, Brasília, Distrito Federal, Brazil
- 3Department of Genomic Sciences and Biotechnology, Catholic University of Brasília, Brasília, Distrito Federal, Brazil
- 4State University of Northern Paraná, Jacarezinho, Paraná, Brazil
- 5Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil
- 6Nefroclínicas Group, Belo Horizonte, Minas Gerais, Brazil
- 7Clinical Group Home Dialysis Center and RenalClass, São Paulo, Brazil
- 8Department of Surgery, Center for Transplantation Sciences, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States
- 9Luxembourg Centre for Systems Biomedicine (LCSB), University of Luxembourg, Esch-sur-Alzette, Luxembourg
- 100Division of Transplantation, University Hospital of Brasília, HUBrasil, Brasília, Distrito Federal, Brazil
- 111Center for Exercise Physiology and Metabolism, Department of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Santiago, Chile
- 122Facultad de Medicina, Universidad Autónoma de Yucatán, Mérida, Yucatan, Mexico
Abstract
Kidney transplantation improves survival and quality of life compared with long-term dialysis, yet many kidney transplant recipients remain characterized by reduced physiological reserve, cardiometabolic vulnerability, and ongoing graft-related risk. Structured exercise is a promising non-pharmacological strategy after transplantation, but its potential immunometabolic and immunomodulatory effects and their relationship with longer-term graft-related trajectories remain insufficiently characterized. The EXercise Training in Kidney TRAnsplant Recipients Trial (EXTRA Trial) is a randomized, assessor-blinded, parallel-group controlled trial that enrolled adult kidney transplant recipients approximately 6 months after transplantation. Participants are allocated 1:1 to usual post-transplant care or a supervised, progressive, combined aerobic and resistance exercise program consisting of a 2-week familiarization period followed by 24 weeks of training. The primary outcomes are the between-group differences in change in peak oxygen uptake (VO2peak) and handgrip strength from baseline to the end of the randomized intervention. VO2peak serves as the principal cardiorespiratory outcome and the basis for the sample-size calculation. Major secondary outcomes include patient-reported physical functioning, habitual physical activity, health-related quality of life, body composition, renal function, blood pressure, and metabolic markers. Exploratory outcomes include rejection-free survival, graft survival, circulating inflammatory cytokines (TNF-α, IL-6, and IL-2), soluble PD-1 and PD-L1, and longer-term trajectories assessed through 24 months after transplantation. The protocol follows SPIRIT 2025 recommendations and integrates exercise physiology, transplant medicine, and immune-related phenotyping to examine whether exercise-induced improvements in physiological reserve are accompanied by measurable inflammatory, immune-checkpoint, and graft-related changesClinical trial registrationClinicalTrials.gov, identifier NCT06216015.
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BibTeX
@article{santos2026exercise,
title = {{Exercise training in kidney transplant recipients (EXTRA Trial): protocol for a randomized controlled trial}},
author = {Rafael L. Santos and Rafael L. Santos and Rafael L. Santos and Thiago S. Rosa and Thiago S. Rosa and Thiago S. Rosa and Samara Sezana-Costa and Samara Sezana-Costa and Suyane R. Lisboa and Suyane R. Lisboa and Marco Aurélio M. Estivalet and Marco Aurélio M. Estivalet and Carlos Ernesto Santos Ferreira and Gislane Ferreira de Melo and Lysleine Alves de Deus and José Adeirton and Michel K. Souza and Anderson S. Haro and Fernando Costa and Mariana Campos A. Mattos and José R. B. Neto and Carmen Tzanno-Martins and Daniel M Mendes and Guilherme T. Ribas and Guilherme T. Ribas and Guilherme T. Ribas and Geraldo R. R. Freitas and Mauricio Castro-Sepulveda and Adriana Bañares-Cruz and Thiago J. Borges and Leonardo V. Riella and Rodrigo P. Neves and Hugo L. Correa and Hugo L. Correa and Hugo L. Correa},
journal = {Frontiers in Nephrology},
year = {2026},
month = oct,
doi = {10.3389/fneph.2026.1972911},
url = {https://doi.org/10.3389/fneph.2026.1972911},
note = {CC BY},
}
RIS
TY - JOUR
TI - Exercise training in kidney transplant recipients (EXTRA Trial): protocol for a randomized controlled trial
AU - Rafael L. Santos
AU - Rafael L. Santos
AU - Rafael L. Santos
AU - Thiago S. Rosa
AU - Thiago S. Rosa
AU - Thiago S. Rosa
AU - Samara Sezana-Costa
AU - Samara Sezana-Costa
AU - Suyane R. Lisboa
AU - Suyane R. Lisboa
AU - Marco Aurélio M. Estivalet
AU - Marco Aurélio M. Estivalet
AU - Carlos Ernesto Santos Ferreira
AU - Gislane Ferreira de Melo
AU - Lysleine Alves de Deus
AU - José Adeirton
AU - Michel K. Souza
AU - Anderson S. Haro
AU - Fernando Costa
AU - Mariana Campos A. Mattos
AU - José R. B. Neto
AU - Carmen Tzanno-Martins
AU - Daniel M Mendes
AU - Guilherme T. Ribas
AU - Guilherme T. Ribas
AU - Guilherme T. Ribas
AU - Geraldo R. R. Freitas
AU - Mauricio Castro-Sepulveda
AU - Adriana Bañares-Cruz
AU - Thiago J. Borges
AU - Leonardo V. Riella
AU - Rodrigo P. Neves
AU - Hugo L. Correa
AU - Hugo L. Correa
AU - Hugo L. Correa
PY - 2026
DA - 2026/10/26
JO - Frontiers in Nephrology
DO - 10.3389/fneph.2026.1972911
UR - https://doi.org/10.3389/fneph.2026.1972911
AB - Kidney transplantation improves survival and quality of life compared with long-term dialysis, yet many kidney transplant recipients remain characterized by reduced physiological reserve, cardiometabolic vulnerability, and ongoing graft-related risk. Structured exercise is a promising non-pharmacological strategy after transplantation, but its potential immunometabolic and immunomodulatory effects and their relationship with longer-term graft-related trajectories remain insufficiently characterized. The EXercise Training in Kidney TRAnsplant Recipients Trial (EXTRA Trial) is a randomized, assessor-blinded, parallel-group controlled trial that enrolled adult kidney transplant recipients approximately 6 months after transplantation. Participants are allocated 1:1 to usual post-transplant care or a supervised, progressive, combined aerobic and resistance exercise program consisting of a 2-week familiarization period followed by 24 weeks of training. The primary outcomes are the between-group differences in change in peak oxygen uptake (VO2peak) and handgrip strength from baseline to the end of the randomized intervention. VO2peak serves as the principal cardiorespiratory outcome and the basis for the sample-size calculation. Major secondary outcomes include patient-reported physical functioning, habitual physical activity, health-related quality of life, body composition, renal function, blood pressure, and metabolic markers. Exploratory outcomes include rejection-free survival, graft survival, circulating inflammatory cytokines (TNF-α, IL-6, and IL-2), soluble PD-1 and PD-L1, and longer-term trajectories assessed through 24 months after transplantation. The protocol follows SPIRIT 2025 recommendations and integrates exercise physiology, transplant medicine, and immune-related phenotyping to examine whether exercise-induced improvements in physiological reserve are accompanied by measurable inflammatory, immune-checkpoint, and graft-related changesClinical trial registrationClinicalTrials.gov, identifier NCT06216015.
SN - 2813-0626
ER -