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临床试验/NCT03530059
NCT03530059已完成不适用

Feasibility at Home of a Rehabilitation Program Before Thoracic Surgery, for Pulmonary Parenchyma Exeresis

University Hospital, Grenoble5 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
5
主要终点
Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery

研究概览

简要总结

This study is a prospective observational study which aim to evaluate the feasibility of a total and systematic home respiratory rehabilitation training program in patients who will undergo thoracic surgery, and otherwise tend to define failure reasons.

详细描述

The aim of this clinical trial is to identify the determining factors which impact a preoperative home respiratory rehabilitation training program success. This success is determined by complete achievement of the program (100%) by the patient.

This rehabilitation program is composed by 4 items:

  • Adapted physical activity : 3 averaging cyclo ergometer or physical activity seances per week (25%)
  • Physiotherapy sessions : 8 seances with a physical therapist (25%)
  • Smokers : Set up of a program to help give up smoking if active smoker (25%)
  • Dietetics : If unintentionally weight loss (>5% total weight in 1 month or >10% in 6 months) or BMI<21 , nutritional assessment is conducted and dietetic program is initiated(25%)

Secondary objectives are :

  • Assessment of postoperative event onset (30 days) (atelectasis, fibro-aspiration, time spent in resuscitation unit, intubation, revision surgery).
  • Link assessment of 100% program success and at least one complication onset.
  • Cost assessment of preoperative rehabilitation program
  • Evaluation of mean hospitalisation duration post surgery (30 days)
  • Average cost assessment of hospitalisation stay per patient.

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

  • Patients who need a respiratory rehabilitation before thoracic surgery for lung resection.
  • Patients addressed to the home heath care provider "AGIR à Dom",
  • Patients must perform at least 2 items of rehabilitation program (Adapted physical activity, Diet, Physiologist, Smoking)

排除标准

  • Patients who participate to another interventional research that may impact this study.
  • Patients unable to get involved to the training program, depending to the investigator's appreciation.

结局指标

主要结局

Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery

时间窗: from date of inclusion until the end of hospitalisation for thoracic surgery, assessed up to 6 months

Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery : * Tobacco: measure of tobacco consumption (self-report) * Dietary: body mass * Physical activity: number of physical activity sessions * Physiotherapy: number of physical therapy sessions

次要结局

  • Hospitalisation duration(from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months)
  • Post operative event number(30 days)
  • Rehabilitation program costs(from date of inclusion until the beginning of hospitalisation for thoracic surgery, assessed up to 6 months)
  • Total hospitalisation cost(from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (5)

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