Assessment, Monitoring and Optimisation of Prehabilitation Patients Using Wearable Fitness Trackers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Total number of minutes of moderate intensity exercise
研究概览
简要总结
Prehabilitation is the use of exercise prior to surgery to improve peoples' fitness, which leads to improved outcomes of surgery. This service is now being run remotely, however, there is little existing evidence to support the best practice for this. Currently, baseline fitness is assessed remotely using either a sit to stand test or a step test. Once completed people are prescribed regular exercises and asked to exercise to a level of intensity using a measure called Rating of Perceived Exertion (RPE). However, these measurements may not be reliable. We are carrying out a study to assess if another waking test (modified Rockport test) and asking patients to exercise to a target heart rate are better measures of assessing baseline fitness and exercise intensity.
All participants will receive weekly telephone calls to check their progress and be provided with a wrist worn fitness tracker (Fitbit). Participants will be randomised to one of two groups. The only difference between the groups will be the way the exercise is prescribed. In one group participants will be asked to complete the exercises to an exercise level they find "somewhat hard". The other group will be asked to complete the exercises to maintain a set heart rate.
All participants will be asked to complete an activity log (submitted weekly) as an online form. A small group of people (maximum 10) will be asked if they would like to complete an in-person baseline fitness assessment also, this is optional.
This study runs for up to eight weeks with participation ending after eight weeks or at the time of surgery, whichever is sooner. In the final week of participation, participants will be asked to complete an online questionnaire about their experience of using a wearable fitness tracker during the prehabilitation programme.
详细描述
Optimising patients pre-operatively or "Prehabilitation" is a relatively new and evolving concept in patient care. Prehabilitation utilises prescribed exercise in the time prior to surgery with the aim of improving a patient's functional capacity enabling them to better withstand the stress of surgery. 1-3 This is required due to the physiological insult cause by surgery, particularly in those with cancer, which in turn results in a decline in patients' function.
Post-operative restorative rehabilitation programmes such as Enhanced Recovery After Surgery (ERAS) are commonplace and used with the aim of returning the patients' function towards their preoperative baseline. ERAS has been shown to improve postoperative outcomes, including length of stay, re-admission, and complication rates.4 Prehabilitation has been shown to both improve cardiovascular fitness prior to surgery5,6 and like ERAS reduce post-operative complications.7,8 However, despite this and unlike ERAS, it's use is still patchy, with no national protocols in existence.
Due to evidence demonstrating its effectiveness, the benefits of commissioning prehabilitation services have been acknowledged in several surgical fields,9 with national policy documents from NHS England placing an emphasis on preventative rehabilitation, delivered before and during cancer treatment.10 As such, the policy environment could be seen as favourable. However, there is little evidence available, and significant heterogeneity in that which is available, for how best to approach a prehabilitation service to achieve the best results.
Physical activity is a core component seen across all reported prehabilitation programmes. However, heterogeneity is seen across multimodal programmes, meaning the type of exercise, duration and supervision of physical activity is inconsistently administered between studies. Additional interventions such as dietary support, psychological wellbeing and smoking cessation are also variably addressed in some studies.
Accurate, reliable, and reproducible assessment of cardiopulmonary fitness is required to effectively prescribe and monitor patients as they progress through a prehabilitation programme. Currently, cardiopulmonary fitness assessment requires patients to attend for in person assessment to undergo Maximal or Submaximal exercise testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Because of the nature of the study and the interventions offered, it will not be possible to blind participants or research assistants to allocation groups.
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
- •Age 18 - 80 years.
- •New diagnosis of non-metastatic oesophago-gastric (OG), hepatobiliary (HPB) or Lung Cancer (LC) being offered surgical resection with curative intent at Imperial College NHS Healthcare Trust (OG/HPB) or Guy's and St Thomas' Hospital (LC).
- •Proficient in English
- •Enrolled in a prehabilitation programme.
- •Capable of providing informed consent and willing to comply with all parts of the protocol.
排除标准
- •Unable to provide informed consent.
- •Non-resectable disease.
- •Declined surgery.
- •No access to smart phone/tablet or internet
- •Involved in other current research or have recently been involved in any research prior to recruitment
结局指标
主要结局
Total number of minutes of moderate intensity exercise
时间窗: Data collected from each participant for up to 8 weeks or until they have undergone their cancer resection. The end of the study will be on completion of data collection from the 82nd participant.
The primary outcome will compare between intervention and control groups the total number of minutes of moderate intensity exercise, i.e., exercise within target range as measure on the Fitbit over the 8 weeks of follow-up
次要结局
- Volume of physical activity (mean MET min/week) achieved.(Data collected from each participant for up to 8 weeks or until they have undergone their cancer resection. The end of the study will be on completion of data collection from the 82nd participant.)
- Patient feedback of using heart rate trackers in a prehabilitation setting - Technology acceptance Model (TAM)(Questionnaire collected from each participant at the end of their heart rate data collection (after 8 weeks or until they have undergone their cancer resection))
- Patient feedback of using heart rate trackers in a prehabilitation setting - UEQ(Questionnaire collected from each participant at the end of their heart rate data collection (after 8 weeks or until they have undergone their cancer resection))
- Weekly adherence (mean percentage of actual/prescribed MET minutes/week)(Data collected from each participant for up to 8 weeks or until they have undergone their cancer resection. The end of the study will be on completion of data collection from the 82nd participant.)
- Patient feedback of using heart rate trackers in a prehabilitation setting - UMUX-lite(Questionnaire collected from each participant at the end of their heart rate data collection (after 8 weeks or until they have undergone their cancer resection))
- Duration of exercise self-reported vs recorded HR data (minutes)(Data collected from each participant for up to 8 weeks or until they have undergone their cancer resection. The end of the study will be on completion of data collection from the 82nd participant.)
- Intensity of exercise self-reported vs recorded HR data (RPE vs % of target HR zone)(Data collected from each participant for up to 8 weeks or until they have undergone their cancer resection. The end of the study will be on completion of data collection from the 82nd participant.)