跳至主要内容
临床试验/NCT04701398
NCT04701398招募中不适用

Frailty in Patients With Advanced Chronic Kidney Disease Waiting for a Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation.

Parc de Salut Mar2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
138
试验地点
2
主要终点
Bad-Outcome Composite Endpoint

研究概览

简要总结

Frailty is very frequent among patients waiting for a kidney transplantation (KT). Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after KT. Frailty in patients with chronic kidney disease (CKD) displays a constellation of features that characterize a special population. Intervention is essential to improve quality of life for frail CKD patients, regardless of their age. A pre-transplant intervention including physical therapy, nutritional measures and psychological support scheduled for before the transplant may improve patient retention and compliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients.

The main objective is to assess effectiveness, feasibility and safety of a prehabilitation program (exercise, nutritional plans, psychological advice) in frail and non-frail KT candidates on clinical and functional outcomes after KT.

详细描述

Frailty is very frequent among patients with chronic kidney disease (CKD) included in the waiting list for deceased donor kidney transplantation (KT), and outcomes are worsened in those frail recipients after KT. Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcareutilization after KT. Frailty in CKD patients displays a unique constellation of features such as muscle wasting, anorexia, protein energy wasting, inflammation, oxidative stress, catabolic/anabolic hormone imbalance, metabolic acidosis, and other cellularalterations that characterize a special population. Intervention is essential to improve quality of life for frail CKD patients, regardless of their age. Efforts to intervene with post- transplant physical therapy have been met with limited success, in large part due to high study dropout. A pre-transplant clinical framework for multimodal prehabilitation interventions including physicaltherapy, nutritional measures and psychological support scheduled for before the transplant may improve patient retention andcompliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients.

The main objective of this study is to assess effectiveness, feasibility and safety of multimodal prehabilitation (exercise, nutritional plans, psychological advice) in frail and non-frail KT candidates in the context of a randomized controlled clinical trial. The primary endpoint will be a composite achievement of clinical and functional outcomes in frail and non-frail KT candidates after KT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients with chronic kidney disease
  • Inclusion in the waiting list for deceased donor kidney transplantation in the period September 2020 to August 2022

排除标准

  • Patients unable to perform the exercise plan or giving informed consent

结局指标

主要结局

Bad-Outcome Composite Endpoint

时间窗: 90 days post-kidney transplantation

Delayed draft function \>14 days + never functioning kidney + non-elective readmission before day 90 + surgical complications (wound healing problems, obstructive lymphocele, vascular thrombosis, urinary stenosis or leak, acute hemorrhage, immediate re-intervention) + discharge to an assisted facility + all-cause death.

次要结局

  • Changes in exercise capacity(Post-intervention (12 weeks))
  • Attendance(Post-intervention (12 weeks))
  • Changes in peripheral muscle strength(Post-intervention (12 weeks))
  • Changes in respiratory muscle strength(Post-intervention (12 weeks))
  • Changes in physical activity(Post-intervention (12 weeks))
  • Changes in muscle mass(1 month post-KT)
  • Changes in mood state(Through study completion, an average of 1 year)
  • Changes in health-related quality of life(Through study completion, an average of 1 year)
  • Exercise tolerability(Post-intervention (12 weeks))

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Sponsor

研究点 (2)

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