Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acceptability of the device
研究概览
简要总结
Hospitalizations are harmful to patients. Without a proper intervention, it will lead to a permanent decline in physical function, especially among frail individuals. Ultimately, this will worsen quality of life, as well as the cognitive and functional status of affected elderly people, which will arguably reduce functional independence, increase post-discharge institutionalization and death among frail older adults. It is known that patients receiving early physical evaluation and rehabilitation (in the 24 hours following admission) improves post-discharge orientation, decreases delirium and the need of acute care. The rehabilitation often involves ergocycles, but commercially available devices are expensive and often hard to move, to set up in hospital bed and lack connectivity.
In this context, a connected ergocycle prototype which has a number of desired characteristics, including low production cost, relatively light and easy to move and with internet connectivity. The goal of this study is thereby to assess the usefulness and acceptability of the prototype with health professionals involved in physical rehabilitation and patients receiving said rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 55 years old
- •receiving treatments for terminal renal insufficiency at least 3 times a week, for at least 3 months (hemodialysis; HD) or under mechanical ventilation for less than 72 hours, and that should last for at least 24 more hours (intensive unit care; ICU)
- •Physically independent outside HD or before admission (ICU) (≥ 70 on the Barthel index)
- •with medical clearance (HD : nephrologist; ICU : intensivist)
排除标准
- •unable to walk without assistance (before ICU admission)
- •diagnosed neurocognitive decline
- •recent hemiarthroplasty for a hip fracture that causes a limitation in the flexion of the hip during pedaling
- •already involved in another study
- •Exclusion Criteria Specific for ICU Patients :
- •neuromuscular disorder affecting the weaning from mechanical ventilator support
- •pathologic fracture or unstable cervical spine fracture
- •hospitalized for more than 7 days
- •COVID-19 positive
- •reported as moribund by the intensivist
研究组 & 干预措施
Intradialytic exercise (patients)
Participants in this group will use the tested device to perform a 30-minute session of aerobic training (cycling during hemodialysis) at 3-4/10 on the Borg scale of perceived exertion.
干预措施: Ergogycle prototype testing for acceptability (Device)
Acute care exercise (patients)
Participants in this group will use the tested device to perform 2 x 10-minute of aerobic training (cycling in the hospital) interspersed with a 5-minute break. Exercise intensity will be of 2/10 on the Borg scale of perceived exertion (around 3 +/- 2 watts at 20 rpm).
干预措施: Ergogycle prototype testing for acceptability (Device)
结局指标
主要结局
Acceptability of the device
时间窗: up to 1 hour after the exercise session for both the patients and professionals
Questionnaire based on the unified theory of acceptance and use of technology
次要结局
未报告次要终点