跳至主要内容
临床试验/NCT05375292
NCT05375292招募中不适用

Efficacy of Pre-Operative Prehabilitation in Patients Undergoing Open Surgery for Abdominal Aortic Aneurysm

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
functional WHODAS 2.0 score

研究概览

简要总结

This is a pilot, prospective, randomized control trial that aim to provide a first estimation of the 3-month post-operative variation in the functional recovery of patients who benefited from an outpatient pre-habilitation program and patients who did not benefit from it.

详细描述

Open surgery of abdominal aortic aneurysms (AAA) is the reference treatment in a large number of cases. This is a heavy procedure performed in patients around 70 years of age.

In post-operative open aortic surgery, a stay in aftercare and rehabilitation is often necessary, especially in fragile patients.

The goal is to increase the patient's overall functional status to allow him to move away from the threshold below which he loses his independence for activities of daily living.

The pre-habilitation protocol includes 3 parts :

  1. Oral nutrition ensures adequate caloric and protein intake to support muscle anabolism
  2. Muscle building over a few sessions with a liberal physiotherapist to learn exercises and then independently
  3. Cardio-respiratory endurance.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with an abdominal aortic aneurysm (Thoraco-abdominal aneurysm type 4/Supra renal/Juxta-renal/Sub renal) treated with conventional surgery.
  • Surgical indication of aneurysm by size (50-55mm)

排除标准

  • Patient requiring urgent management that does not allow for a pre-authorisation protocol of at least 6 weeks.

结局指标

主要结局

functional WHODAS 2.0 score

时间窗: 3 months after the open surgery for AAA

the WHODAS 2.0 score ranges from 12 to 60 : 12 representing no difficulty at all, 60 representing worst difficulty to engage in usual activities

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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