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临床试验/NCT06443138
NCT06443138招募中不适用

Preparation for Medical and Surgical Procedures in Oncogeriatry. Pilote Study PRIMECHO

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Maximal walking distance to 6 -MWT

研究概览

简要总结

Surgical management is one of the most frequently used interventions in the treatment of many cancers, but it can be associated with a high risk of postoperative complications.

The maintenance and optimization of functional abilities before, during and after treatment are major for elderly cancer patients, as it is now well established that there is a link between the level of functional capacity and the occurrence of these complications.

The scientific literature shows that the benefits of pre- and post-operative training programs, but these benefits only apply to a fraction of the patients adhering to the programs. The modalities of intervention (training load, follow-up, etc.) as well as patient involvement in these programs are major issues that need to be addressed to optimize their benefits.

Individualizing pre-habilitation, on the basis of the management of the training load, and therefore objective fatigue, would enable better patient adherence to the program, and optimize its benefits.

In this context, the PRIMECHO project aims to individualize pre-habilitation in order to improve functional of patients in the pre-habilitation or accelerated recovery after surgery phase. The aim is for the patient to be in optimum physical condition at the time of the intervention or treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patient aged 70 or over
  • Cancer patient with planned surgery,
  • Mini Mental State Examination score greater than or equal to 24 (performed in advance by the geriatrician),
  • Patient affiliated to or benefiting from a social security insurance
  • Signed free and informed consent.

排除标准

  • Inability to walk or perform unsupervised exercises.
  • Vulnerable people

研究组 & 干预措施

Personalized pre-habilitation program

Experimental

干预措施: Personalized pre-habilitation program (Other)

结局指标

主要结局

Maximal walking distance to 6 -MWT

时间窗: at 16 weeks

Metres walked during the test

次要结局

  • Internationnal Physiqual activity questionaire (IPAQ-short)(at inclusion, 4 weeks, 8 weeks, 16 weeks)
  • EORTC-QLQC30(at inclusion, 4 weeks, 8 weeks, 16 weeks)
  • Fatigue scale (MFI-20)(at inclusion, 4 weeks, 8 weeks, 16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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