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临床试验/NCT07338929
NCT07338929招募中不适用

Physical Performance Assessment in Kidney Transplant Evaluation Using the Short Physical Performance Battery (SPPB)

University Hospital, Martin1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
To assess changes in physical performance using SPPB scores before and after kidney transplantation.

研究概览

简要总结

This prospective cohort study investigates physical frailty, assessed by the Short Physical Performance Battery (SPPB), in patients evaluated for kidney transplantation. The study aims to compare SPPB scores before listing, annually during the waiting period, and after transplantation at 6 and 12 months. It also includes a control group of dialysis patients not eligible for transplantation to evaluate differences in physical performance. The goal is to understand how frailty impacts transplant outcomes and patient recovery.

详细描述

This longitudinal, prospective study focuses on assessing the role of physical frailty in patients undergoing evaluation for kidney transplantation using the Short Physical Performance Battery (SPPB). The study will enroll adult patients who are being assessed for kidney transplantation, including those who are deemed suitable and placed on the waiting list (Arm A) and those on dialysis who are considered unsuitable for transplant listing (Arm B).

Participants will undergo comprehensive SPPB assessments at baseline, during their evaluation process, and subsequently at annual follow-up intervals. For listed patients, the assessments will be performed upon initial evaluation, then annually while on the waiting list, and at 6 and 12 months following transplantation. For patients ineligible for the transplant list and on dialysis, the SPPB will be recorded at baseline and then annually, allowing cross-sectional comparison and understanding of their physical performance trajectory.

The primary objective is to evaluate changes in physical performance over time with the SPPB score, which ranges from 0 to 12. The scores will be used to categorize participants into frail, pre-frail, or non-frail groups, providing insights into the prevalence and evolution of frailty in this population.

Secondary objectives include comparing the baseline and follow-up SPPB scores between the two arms, correlating physical performance with post-transplant outcomes such as graft function and survival, and identifying potential predictors of frailty that could inform prehabilitation interventions.

This study may inform future strategies to optimize physical function in kidney transplant candidates and improve clinical outcomes through targeted interventions addressing physical frailty.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adult patients (≥18 years) undergoing evaluation for kidney transplantation.
  • Patients on dialysis.
  • Ability and consent to participate.

排除标准

  • Non-adult patients.
  • Patients unable to provide informed consent.
  • Acute medical conditions prohibiting SPPB assessment.

研究组 & 干预措施

kidney transplant recipients

The study will enroll adult patients who are being assessed for kidney transplantation, including those who are deemed suitable and placed on the waiting list (Arm A) and those on dialysis who are considered unsuitable for transplant listing (Arm B).

结局指标

主要结局

To assess changes in physical performance using SPPB scores before and after kidney transplantation.

时间窗: 3-5 years

Characterization of physical performance levels in patients considered for kidney transplantation.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Martin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matej Vnucak

associate professor

University Hospital, Martin

研究点 (1)

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