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临床试验/NCT04667065
NCT04667065已完成不适用

Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery

Centre Hospitalier Intercommunal Creteil1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Measure of VO2 max .

研究概览

简要总结

This is a study of a preoperative rehabilitation program with remotely guided high-intensity exercises by physical activity teachers adapted to a smartwatch in patients with operable lung cancer.

研究设计

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

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

  • Major patient, age ≥ 18
  • Patient with non-small cell operable bronchial cancer without indication of neo-adjuvant chemotherapy
  • Affiliated with a social security plan
  • VEMS < 80% and/or DLCO<80%
  • High-intensity training achievable for at least 10 days before surgery
  • Acceptant to participate in the protocol
  • Ability to follow the STIMUL program of education focused on adapted physical activity
  • Have a smartphone that can download the mobile app
  • have the ability to understand, read and write French

排除标准

  • Patient unable to consent: under guardianship or curatorship
  • Patient refusing surgery
  • Non-operable patient due to comorbidities or unseable tumour
  • Poor understanding of the smartwatch
  • Severe cognitive or psychiatric disorders
  • Pregnancy in progress

结局指标

主要结局

Measure of VO2 max .

时间窗: 1 day before surgery

comparison of VO2 max at inclusion and one day before surgery

次要结局

  • post-surgery complications(At 1 month and 3 months)
  • number of individuals who participated in the physical activity program(one day before surgery)
  • post surgery intubation duration(At 1 month)
  • Number of patients who used the remotely guided physical preparation(one day before surgery)
  • maximum distance covered in the 6-minute walking t(one day before surgery)
  • number of days with oxygen(At 1 month and 3 months)
  • (forced expiratory volume(At 1 month and 3 months)
  • number of days at hospital(At 3 months)
  • capacity of carbon monoxide(At 1 month and 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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