跳至主要内容
临床试验/NCT06492161
NCT06492161已完成不适用

Evaluation of an Application Allowing Physical Activity to Get Information on Their Physical Activity in the First Days Following Thoracic Surgery

Hopital Foch1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
28
试验地点
1
主要终点
Assess the agreement between ACTIM application and Actilife Softawre for sitting-standing transition

研究概览

简要总结

Although there is a strong physiological rationale for the benefit of post-operative mobilization, the evidence supporting these effects in surgical cohorts is conflicting, and there is a lack of research to guide the clinical implementation of early mobilization protocols. There is also a need to better evaluate the physical activity performed by physical activity tients outside the supervised mobilization protocol, to better understand its potential benefits on post-operative recovery. In adition, the objective measurement of physical activity has several advantages over declarative measures.

详细描述

Prolonged immobilization after surgery is known to have detrimental effects. Although postoperative recommendations favor early mobilization, the lack of quantification of physical activity poses a problem for the implementation of early mobilization protocols..

An application named "ACTIM" has been developed with the aim of automating the personalized assessment of postoperative physical activity. The healthcare team (nurses or physiotherapists…), will share the information with the patient and will complete the assessment using personalized physical activity objectives for the day.

The purpose of this study is to assess this application in real-life settings to provide patients with information on their physical activity after lung resection by thoracoscopy or robotic surgery. This assessment will serve as a reference for future studies.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient 18 years of age or older
  • •Scheduled for thoracoscopic or robotic lung resection
  • •Agreeing to wear an ActiGraph GT3X accelerometer from 4 days post-surgery
  • •Having signed a consent form
  • •Affiliated with a health insurance

排除标准

  • •Pregnant or breastfeeding woman
  • •Patient unable to move independently (paraplegic, etc.)
  • •Patient deprived of liberty or under guardianship

研究组 & 干预措施

GT3X ActiGraph's activity monitor

Experimental

Patients who have undergone thoracic surgery wearing an ActiGraph GT3X-BT device that measures and records physical movement associated with daily activity.

干预措施: Physical activity measure (Device)

结局指标

主要结局

Assess the agreement between ACTIM application and Actilife Softawre for sitting-standing transition

时间窗: up to 4 days

Measure, from postoperative Day 1 up to Day 4 of number of sit-to-stand transitions

Assess the agreement between ACTIM application and Actilife Softawre for step count

时间窗: up to 4 days

Measure, from postoperative Day 1 up to Day 4 of number of number of steps

Assess the agreement between ACTIM application and Actilife Softawre for walking pace

时间窗: up to 4 days

Measure, from postoperative Day 1 up to Day 4 of number of walking cadence

Assess the agreement between ACTIM application and Actilife Softawre for the sitting-lying position

时间窗: up to 4 days

Measure, from postoperative Day 1 up to Day 4 of time spent sitting/lying-down

次要结局

  • Record postoperative complications(up to 4 days)
  • Measuring changes in physical activity with ACTIM application from postoperative Day 1 up to Day 4(up to 4 days)
  • Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of duration(up to 4 days)
  • Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of duration of walking at each intensity(up to 4 days)
  • Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of sedentary(up to 4 days)
  • Assess of the practical feasibility and level of satisfaction of the medical team regarding the personalized assessment obtained through ACTIM application(up to 4 days)
  • Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of physical activity intensity(up to 4 days)
  • Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of energy expenditure(up to 4 days)
  • Assess patient acceptability of wearing the ActiGraph GT3X(up to 4 days)
  • Record patients' interest in the format and information contained in the personalized report(up to 4 days)
  • Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4(up to 4 days)
  • Measuring changes in physical activity with Actilife Softawre from postoperative Day 1 up to Day 4 of moderate to high-intensity physical activity(up to 4 days)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验