PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial.
Quint, E. E., et al.BMJ Open 2023; 13(7): e072805.
Aims
This protocol for a randomised controlled trial aims to evaluate the effectiveness of a prehabilitation programme among kidney transplant candidates.
Interventions
Participants will be randomised to either the prehabilitation group or the usual care group.
Participants
Adult kidney transplant candidates that are currently on the transplant waiting list or are waitlisted during the study period.
Outcomes
The primary outcome is change in frailty status. The secondary outcomes are changes in physical fitness, psychological well-being, nutritional status, quality of life and clinical outcomes.
Follow-up
26 weeks post-randomisation.
CET Conclusions
This study protocol outlines the rationale and methodology for a proposed randomised control trial which will assess the efficacy of a prehabilitation program applied to patients awaiting kidney transplantation. Patients will be randomised to either routine care or a 12-week home-based program compromised of physical, nutritional and psychosocial interventions. The primary outcome is a change of score on the Tilburg Frailty Indicator (TFI), a validated frailty assessment tool. Of note, all outcome measures are pre-operative only i.e. the post-operative and long-term outcomes related to graft and patient survival will not be assessed in this trial.
Trial registration
ClinicalTrials.gov - NCT05489432