TY - JOUR
T1 - PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study
T2 - protocol for a hybrid type I, mixed method, randomised controlled trial
AU - PreCareTx Investigators
AU - Quint, Evelien E
AU - Haanstra, Avril J
AU - van der Veen, Yvonne
AU - Maring, Heleen
AU - Berger, Stefan P
AU - Ranchor, Adelita
AU - Bakker, Stephan J L
AU - Finnema, Evelyn
AU - Pol, Robert A
AU - Annema, Coby
N1 - © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/7/27
Y1 - 2023/7/27
N2 - INTRODUCTION: Kidney transplant candidates (KTCs) need to be in optimal physical and psychological condition prior to surgery. However, KTCs often experience compromised functional capacity which can be characterised as frailty. Prehabilitation, the enhancement of a person's functional capacity, may be an effective intervention to improve the health status of KTCs. The PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study aims to examine the effectiveness of a multimodal prehabilitation programme on the health status of KTCs, and to explore the potential of implementation of prehabilitation in daily clinical practice.METHODS AND ANALYSIS: This study uses a single centre, effectiveness-implementation hybrid type I study design, comprised of a randomised controlled trial and a mixed-methods study. Adult patients who are currently on the transplant waiting list or are waitlisted during the study period, at a university medical centre in The Netherlands, will be randomly assigned to either prehabilitation (n=64) or care as usual (n=64) groups. The prehabilitation group will undergo a 12-week home-based, tailored prehabilitation programme consisting of physical and/or nutritional and/or psychosocial interventions depending on the participant's deficits. This programme will be followed by a 12-week maintenance programme in order to enhance the incorporation of the interventions into daily life. The primary endpoint of this study is a change in frailty status as a proxy for health status. Secondary endpoints include changes in physical fitness, nutritional status, psychological well-being, quality of life and clinical outcomes. Tertiary endpoints include the safety, feasibility and acceptability of the prehabilitation programme, and the barriers and facilitators for further implementation.ETHICS AND DISSEMINATION: Medical ethical approval was granted by the Medical Ethics Committee Groningen, Netherlands (M22.421). Written informed consent will be obtained from all participants. The results will be disseminated at international conferences and in peer-reviewed journals.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT05489432.
AB - INTRODUCTION: Kidney transplant candidates (KTCs) need to be in optimal physical and psychological condition prior to surgery. However, KTCs often experience compromised functional capacity which can be characterised as frailty. Prehabilitation, the enhancement of a person's functional capacity, may be an effective intervention to improve the health status of KTCs. The PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study aims to examine the effectiveness of a multimodal prehabilitation programme on the health status of KTCs, and to explore the potential of implementation of prehabilitation in daily clinical practice.METHODS AND ANALYSIS: This study uses a single centre, effectiveness-implementation hybrid type I study design, comprised of a randomised controlled trial and a mixed-methods study. Adult patients who are currently on the transplant waiting list or are waitlisted during the study period, at a university medical centre in The Netherlands, will be randomly assigned to either prehabilitation (n=64) or care as usual (n=64) groups. The prehabilitation group will undergo a 12-week home-based, tailored prehabilitation programme consisting of physical and/or nutritional and/or psychosocial interventions depending on the participant's deficits. This programme will be followed by a 12-week maintenance programme in order to enhance the incorporation of the interventions into daily life. The primary endpoint of this study is a change in frailty status as a proxy for health status. Secondary endpoints include changes in physical fitness, nutritional status, psychological well-being, quality of life and clinical outcomes. Tertiary endpoints include the safety, feasibility and acceptability of the prehabilitation programme, and the barriers and facilitators for further implementation.ETHICS AND DISSEMINATION: Medical ethical approval was granted by the Medical Ethics Committee Groningen, Netherlands (M22.421). Written informed consent will be obtained from all participants. The results will be disseminated at international conferences and in peer-reviewed journals.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT05489432.
KW - Adult
KW - Humans
KW - Frailty/rehabilitation
KW - Preoperative Exercise
KW - Quality of Life
KW - Kidney Transplantation
KW - Physical Fitness
KW - Randomized Controlled Trials as Topic
U2 - 10.1136/bmjopen-2023-072805
DO - 10.1136/bmjopen-2023-072805
M3 - Article
C2 - 37500274
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e072805
ER -