跳至主要内容
临床试验/NCT06716437
NCT06716437招募中不适用

Digitally Enabled Prehabilitation in a Community-based Setting for Patients Undergoing Lung Cancer Surgery

University of Melbourne2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
2
主要终点
Feasibility of the intervention

研究概览

简要总结

Major surgery has been linked to running a marathon as in both represent large endeavours where the body will experience an increase in demands to supply the necessary energy. It has been alledged that, as one would train to prepare for a marathon, the same should be applied to surgery. The process of getting ready and/or fitter for surgery is frequently referred to as prehabilitation and it usually involves interventions on improving nutrition and diet, getting fit and improve emotional wellness. Prehabilitation can improve the recovery after surgery and reduce the time spent in hospital afterwards. This research seeks to determine whether a home based program of increased physical activity and breathing training can improve patients' physical and respiratory function in preparation for lung cancer surgery.

详细描述

Patients with lung cancer who are scheduled to undergo lung resection surgery will be provided with a digitally-enabled, remotely-monitored prehablitation program. The intervention will consist of the following components: i) general education; ii) inspiratory muscle training; iii) physical activity coaching; and iv) home-based exercise training. The program will be supported with a mobile app and weekly telehealth sessions with one experienced physiotherapist. Participants will be assessed at baseline and at the end of the intervention, prior to surgery. Participants will be contacted and scheduled to undergo face-to-face assessments on lung function, respiratory muscle strength, and functional capacity both at baseline and after the prehabilitation program.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Diagnosis of lung cancer and scheduled for lung resection surgery
  • Ability to understand and speak English to follow instructions and complete the intended assessments.
  • Age ≥ 18 years at the point of baseline screening
  • Provide written informed consent for the trial
  • Sufficient digital literacy to use a smartphone and mobile app
  • No contraindications for exercise

排除标准

  • Other cancer diagnoses than lung cancer
  • Surgery scheduled in less than one week
  • Unstable psychiatric, cognitive or substance abuse disorders that would interfere with cooperation with the requirements of the trial

结局指标

主要结局

Feasibility of the intervention

时间窗: From enrollment to the end of the study approximately one week after surgery

Feasibility of the intervention determined by enrolment rate (number of patients who accept participation in the trial vs. number of eligible patients)

App usability and acceptability

时间窗: Within one week before surgery

The app usability will be measured with a questionnaire (the mHealth App Usability Questionnaire). The questionnaire consists of 21 items on a likert scale ranging from 1 (disagree) to 7 (agree) assessing different domains of a mHealth app. A median of 4.5 out of 7 across all domains will be considered as high usability and acceptability.

次要结局

  • Safety of the intervention(From enrollment to the end of the program before surgery)
  • Inspiratory Muscle Strength(Within one week before surgery)
  • Diaphragmatic excursion and thickness(Within one week before surgery)
  • Lung function(Within one week before surgery)
  • Self-efficacy(Within one week before surgery)
  • Participant satisfaction(Within one week before surgery)
  • Health Related Quality of Life(Within one week before surgery)
  • Recovery from surgery(Within one week before surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验