Effectiveness and mechanisms of digital cognitive and physical function prehabilitation for improving prognosis in kidney transplant recipients: protocol for a randomised controlled trial
摘要
Frailty and cognitive impairment are highly prevalent among patients on the kidney transplant waitlist (KTWs), contributing to poor post-transplant outcomes. While digital health interventions have shown promise in chronic disease management, their application as a comprehensive prehabilitation tool for KTW patients remains largely unexplored. This study aims to evaluate the effectiveness of a digital cognitive and physical prehabilitation program in improving the prognosis for KTW patients. Furthermore, it seeks to investigate the underlying biological mechanisms, focusing on the inflammation-muscle-brain axis.
MethodsThis single-center, assessor-blinded, randomized controlled trial will enroll 100 eligible KTW patients. Participants will be allocated (1:1) to either an intervention group or an active control group. The control group will receive standard care plus a digital platform for daily health management. The intervention group will receive, in addition, a 12-week, home-based program of digitally supervised exercise (aerobic and resistance) and cognitive training.
ResultsThe primary outcomes will include changes in physical function (evaluated through the 6-min walk test, sit-to-stand test, timed up-and-go test, and handgrip strength) and cognitive function (assessed using the Montreal Cognitive Assessment and Digit Symbol Substitution Test). Key clinical transplant outcomes, such as delayed graft function, graft survival, patient survival, and rejection episodes, will also be assessed. Secondary outcomes will encompass longitudinal changes in biomarkers related to the inflammation-muscle-brain axis (including inflammatory cytokines, myokines, and neurological markers), as well as patient-reported quality of life (SF-36) and vascular function (brachial-ankle pulse wave velocity).
ConclusionThis study will provide critical evidence on the implementation of a multimodal digital prehabilitation strategy in KTW patients. The results are expected to inform future clinical guidelines and offer a scalable model to optimize pre-transplant fitness.
Trial registrationChinese Clinical Trial Registry (ChiCTR) identifier number: ChiCTR2500104025. Registered on 10 June 2025.