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临床试验/NCT06565832
NCT06565832已完成不适用

Reproducibility of Virtual Exercise Assessments Versus Face-to-face Exercise Testing in Adults With Cystic Fibrosis - a Pilot Feasibility Study

Royal Brompton & Harefield NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2023年5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
19
试验地点
2
主要终点
Aerobic Capacity from the Chester Step test

研究概览

简要总结

RExA-CF is investing if results from exercise tests (the Chester Step Test and the One-Minute Sit-to-Stand test) completed face to face are comparable to results of the same tests completed via a virtual teleconferencing platform. The study involves two exercise testing sessions (one face-to-face and one via a video link), with participants being randomised to complete the two exercise tests (the 1-minute sit-to-stand test and the Chester Step test). The two testing sessions will be completed within three weeks of each other, the order of which will be randomly allocated. One session will be completed face-to-face during a pre-arranged visit to the hospital, the other test session will be completed through a video call at a time convenient to the participants. After the second testing session participants will be asked some questions about the face-to-face and video tests to get their views about the two formats.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of cystic fibrosis (as confirmed by standard criteria)
  • Sixteen years of age or over
  • Home internet access
  • Stable CF disease as judged by the medical team
  • Registered with the Royal Brompton Hospital adult CF team

排除标准

  • Inability to give consent for treatment or measurement
  • Current participation in another interventional study
  • Current moderate haemoptysis (greater than streaking in the sputum)
  • Pregnancy
  • Forced expiratory volume in 1 second (FEV1) below 30% predicted
  • Dependency upon oxygen therapy (with home oxygen concentrators or portable oxygen cylinders) or non-invasive ventilation (NIV)
  • Current neurological or musculoskeletal injury which would prevent completion of exercise tests
  • Inability to complete the second set of exercise tests within three weeks

结局指标

主要结局

Aerobic Capacity from the Chester Step test

时间窗: Completed at week 0 and within 2 weeks of first test

This test involves the participant stepping up and down off of a step (this can be a bottom stair or doorstep at home) keeping up with the beat of a recording. The speed of the beat increases every 2 minutes, and the test continues until the participant cannot keep up with the pace, wish to stop or the test ends which takes 10 minutes. Participants will be asked to take their heart rate and oxygen levels before and after the test using a provided pulse-oximeter. This test should take a maximum of 15 minutes. The results of the test will be used to calculate the participants aerobic capacity (range 0-60)

Number of sit to stands completed during One-Minute Sit-to-Stand test

时间窗: Completed at week 0 and within 2 weeks of first test

This test involves the participant sitting down and standing up from a normal height chair (can be a dining room or kitchen chair at home) for one minute. Participants can rest or stop at any time if fatigued. This test should take a maximum of 5 minutes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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