Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Department of Health Sciences, Section of Nursing Science, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
BMJ Open. 2023 Jul 27;13(7):e072805. doi: 10.1136/bmjopen-2023-072805.
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.
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.
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.
ClinicalTrials.gov, NCT05489432.
肾脏移植候选人（KTC）在手术前需要保持最佳的身体和心理状态。然而，KTC 通常会经历功能能力受损，这种情况可以被描述为虚弱。预康复，即增强一个人的功能能力，可能是改善 KTC 健康状况的有效干预措施。候选肾脏移植者的预康复（PreCareTx）研究旨在检验一种多模式预康复方案对 KTC 健康状况的有效性，并探索预康复在日常临床实践中的潜在应用。
本研究采用单中心、有效性-实施混合 I 型研究设计，包括一项随机对照试验和一项混合方法研究。荷兰一所大学医学中心的移植等待名单上的成年患者或在研究期间等待的患者将被随机分配到预康复（n=64）或常规护理（n=64）组。预康复组将接受为期 12 周的家庭为基础的、量身定制的预康复计划，包括物理和/或营养和/或心理社会干预，具体取决于参与者的缺陷。该计划将随后进行为期 12 周的维持计划，以增强干预措施融入日常生活。本研究的主要终点是作为健康状况替代指标的虚弱状态的变化。次要终点包括身体机能、营养状况、心理幸福感、生活质量和临床结局的变化。三级终点包括预康复计划的安全性、可行性和可接受性，以及进一步实施的障碍和促进因素。
荷兰格罗宁根医学伦理委员会（M22.421）批准了医学伦理。将从所有参与者处获得书面知情同意。研究结果将在国际会议和同行评议期刊上发表。
ClinicalTrials.gov，NCT05489432。
