Trimodal Prehabilitation Programme Using Smart Watches and Mobile Applications in Patients Undergoing Major Abdominal Surgery: a Randomised Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quantitative data collected via a Fitbit
研究概览
简要总结
Prehabilitation programmes have the potential to reduce post-operative complications following abdominal cancer surgery by improving pre-operative fitness levels. Home-based prehabilitation programmes may be more cost effective than hospital-based programmes, but have issues with low compliance. The aims of our study are to assess whether mobile technologies such as smart watches and smartphone applications improve compliance with home-based prehabilitation programmes and to assess the effects of prehabilitation on pre-operative fitness levels in patients due to undergo major abdominal cancer surgery.
详细描述
30 patients due to undergo major abdominal cancer surgery at The Christie NHS Foundation Trust will be enrolled to a pilot randomised controlled trial. They will randomised to either a home-based trimodal prehabilitation programme, delivered by the use of FitBit Smart Watches and Smartphone applications, or a control group who will receive a FitBit for physical activity monitoring only, for a period of 2-6 weeks prior to surgery. The prehabilitation programme will include exercise, nutritional, and psychological components. Study outcomes will include 6MWT (6-minute walk test), HADS (hospital anxiety and depression score), steps per day, length of stay post-operatively, and post-operative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
There is no masking. Both the investigator and participant will be aware of which arm they have been randomised to.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be aged 18 years or over
- •be able to consent to participate in the prehabilitation programme
- •be undergoing major abdominal cancer surgery (including, but not limited to, cytoreductive surgery with hyperthermic intraperitoneal chemotherapy)
- •have at least 2 weeks to their operation date
- •be able to understand written and spoken English
排除标准
- •patients have any health conditions which will prevent them from safely taking part in a home-based exercise programme. For example, but not limited to, patients who have recently (within the past 3 months) had a myocardial infarction or a stroke or patients who have end-stage renal disease but are not on dialysis. We will use the "Safety Reference Guide to support exercise services in people with cancer" in The Lancet published paper "Exercise as part of routine cancer care"(5) to aid the screening of patients suitability.
- •they have any bone metastasis
- •are already active users of a FitBit device
研究组 & 干预措施
Prehabilitation
These participants will receive a home based prehabilitation programme for a period of 2-6 weeks prior to surgery and will be provided with a Fitbit Charge 2.
干预措施: Monitoring using a FitBit (Other)
Control
These participants will receive a Fitbit Flex and told to continue with their every day activity levels for a period of 2-6 weeks prior to surgery
干预措施: Monitoring using a FitBit (Other)
结局指标
主要结局
Quantitative data collected via a Fitbit
时间窗: Each participant will be monitored for a period of 2-6 weeks pre surgery
Data will be collected to determine the number of participants whose physical activity increased and by how much during the study
次要结局
- Qualitative data collected by questionnaire(Each participant will be monitored for a period of 2-6 weeks pre surgery)
- Quantitative data associated with participants weight at the start and end of the research intervention(Each participant will be monitored for a period of 2-6 weeks pre surgery)
研究者
Shira Baram
Research Project Manager
University of Manchester