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临床试验/NCT05114408
NCT05114408Unknown不适用

The Influence of Prehabilitation on the Surgical Patients Condition

Medical University of Gdansk2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年6月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
6 minute walk test

研究概览

简要总结

Patients scheduled for elective surgery will undergo 4 week course of trimodal prehabilitation

详细描述

Patients with high surgical risk will participate in 4 week prehabilitation that will consist of 4 stationary sessions - one per week - comprised of: physiotherapy session, psychological session and nutritional advice. During first session each patient will receive an activity monitor and dedicated mobile app that will record his daily performance.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 70 and/or American Society of American Society of Anesthesiologists Physical Status Classification System (ASA) 3-4
  • Unfit patients

排除标准

  • physical condition that makes the patient is not able to perform rehabilitation exercises
  • cardiac and respiratory instability or high risk of its occurrence
  • inability to use electronic devices used in the study

结局指标

主要结局

6 minute walk test

时间窗: baseline and pre surgery

change in aerobic capacity

Yale Physical Activity Survey (YPAS)

时间窗: baseline and pre surgery

change in physical activity

self-perceived health status scale (36-Item Short Form Survey - SF36)

时间窗: baseline and pre surgery

change in self-perceived health status (0 - min, 100 - max self perceived health score)

Global Leadership Initiative on Malnutrition (GLIM) scale

时间窗: baseline and pre surgery

change in nutritional status - malnutrition diagnosed if one phenotypical and one etiological criteria are fulfilled Severity based on phenotypic criteria: 1. minimal value (moderate malnutrition) 2. max value (severe malnutrition)

Hospital Anxiety and Depression (HAD) scale

时间窗: baseline and pre surgery

change in psychological status: depression and anxiety criteria 0 points min score - low level od depression and anxiety 21 max score

motivation questionaire (MQ)

时间窗: baseline and pre surgery

change in patient's motivation 0-10 0 - low motiwation 10 max motivation

Perceives stress - Perceived Stress Questionaire (PSS)

时间窗: baseline and pre surgery

stress level - 0 - min value - no perceived stress 20 - maximal preceived stress

次要结局

  • Number of Patients with postoperative complications(3 month after surgery)
  • Number of Patients requiring Emergency room visits and hospital readmissions(at 30 days)
  • Number of Participants requiring reintervention during initial hospitalization(3 months after surgery)
  • ICU length of stay(3 months after surgery)
  • Total hospital length of stay(3 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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