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Home-based exercise and physical activity intervention after kidney transplantation: impact of exercise intensity (PHOENIX-Kidney). Protocol for a multicentre randomized controlled trial

S. De Smet,M. Vandecruys,Jasmine De Beir,S. Leunis,Karsten Vanden Wyngaert,Marie Renier,H. de Loor,K. Goetschalckx,M. Naesens,D. De Smedt,Francis Verbeke,Ingeborg Stalmans,Steffen Fieuws,G. Glorieux,Jan Van Eijgen,Hanne Van Criekinge,Jeroen Raes,Sabina De Geest,W. van Biesen,Dirk R. J. Kuypers,Evi Nagler,P. Calders,D. Monbaliu,Véronique Cornelissen,A. V. Van Craenenbroeck

Published 2025 in Clinical Kidney Journal

ABSTRACT

ABSTRACT Background Cardiovascular (CV) disease represents a leading cause of death in kidney transplant recipients (KTRs). Poor physical fitness adds to the increased CV risk of KTRs. Exercise-based rehabilitation and physical activity interventions may prove pivotal in both short and long-term outcomes after kidney transplantation. Methods PHOENIX-Kidney is a prospective, multicentre, randomized, controlled, single-blinded trial with parallel groups. A total of 147 adult de novo KTRs from two independent Belgian transplant centres will be randomized to one of three groups with different exercise intensity: (i) 6 months moderate-intensity aerobic and muscle strengthening exercise training followed by a physical activity intervention (MIT, n = 49), (ii) 6 months moderate- and high-intensity aerobic exercise training and moderate-intensity muscle strengthening exercise training followed by a physical activity intervention (MHIT, n = 49), or (iii) sham exercise training, not followed by a physical activity intervention (CON, n = 49). The training and physical activity interventions are home-based programmes, which will be initiated at 3 and 9 months after transplantation, respectively. Study participants will be followed up until 2 years after transplantation. The primary hypothesis is that peak oxygen uptake (VO2peak) assessed after the 6-month home-based training programme (the primary outcome) will increase more in MHIT than in CON. Secondary hypotheses are that VO2peak will increase more in MIT compared to CON, and more in MHIT compared to MIT. Secondary endpoints encompass changes in 6-minute walking distance, endothelial function (flow-mediated dilation of the arteria brachialis), health-related quality of life, physical activity, and safety. Conclusion PHOENIX-Kidney is the first adequately powered RCT to address the question of optimal training intensity in KTRs. Moreover, the implementation potential of a home-based exercise programme followed by a physical activity intervention will be formally assessed in a real-world clinical setting. Clinical Trial Registration Clinicaltrials.gov identifier number: NCT06260579.

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