Impact of a Multimodal Prehabilitation Programme on Markers of Health, Quality of Life and the Short and Long Post-surgery Recovery Period in Cancer Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Changes in Short Physical Performance Battery (SPPB) at different time points from baseline to 1 year after surgery
研究概览
简要总结
Surgical prehabilitation refers to pre-operative interventions aimed at increasing patients' physiological reserve so that they can better cope with the stress of surgery, avoid post-operative complications and have a faster recovery after surgery. Multimodal prehabilitation combines different aspects related to a healthy lifestyle including but not limited to; physical activity, nutritional education, anxiety coping strategies, alcohol moderation and smoking cessation. Although these aspects are well known, having a cancer diagnosis and the likelihood of an incoming operation during the weeks after diagnosis, place patients in a situation where they may be more receptive to adopting lifestyle changes aimed at promoting health. Such changes could be incorporated, not just in the short-term in preparation for surgery, but also in the medium- and long-term, improving patients' wellbeing and potentially reducing the risk of cancer reoccurrence and other diseases.
Although the benefits of prehabilitation before surgery are understood, the effects it may have in non-insulin-dependent Type 2 diabetes patients are unknown.
This project aims to: (i) Analyse the effects of a multimodal prehabilitation programme vs. the current National Health Service (NHS) standard approach, on physical performance in cancer patients with non-insulin-dependent Type 2 diabetes prior to surgery. (ii) Explore the impact of the programme on body composition and metabolic markers. (iii) Analyse the programme adherence, markers of well-being and quality of life during a post-surgery period of up to 12 months as well as its effects on clinical outcomes.
详细描述
This study will take advantage of already existing infrastructures, by approaching a single National Health Service (NHS) hospital in England that is already run a prehabilitation service for its patients. This study will analyse the effect of the prehabilitation programme on a specific group of patients, those with cancer and Type 2 diabetes who do not require insulin as part of their diabetes treatment and who are waiting for surgery.
Surgical prehabilitation refers to interventions done before surgery to increase the patient's overall health and fitness so that they can better cope with the stress of surgery, avoid complications/reduce, and have a faster recovery after surgery. Multimodal prehabilitation combines different aspects related to a healthy lifestyle, including but not limited to; physical activity, nutritional education, anxiety coping strategies, alcohol moderation and smoking cessation.
Multimodal prehabilitation programmes may use a combination of telehealth and face-to-face delivery to provide flexibility according to the preferences of the patients.
The collaboration between the University of Greenwich and NHS will provide an opportunity to measure the impact of the programme on those participants with Type 2 diabetes, beyond variables like weight and fasting blood glucose (i.e., body composition, glycaemic behaviour, blood insulin concentration, immune system markers...).
The hospital prehabilitation team will identify potential study participants (patients with Type 2 diabetes who do not use insulin awaiting surgery) amongst those referred to their service. The prehabilitation team will present the idea of the study to the potential participants and will ask for consent to share their contact details with the sponsor. If consent is received, the researcher will contact them to briefly present to them the possibility of joining the study. This 1st contact will be overseen by the Chief Investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Capacity to give consent
- •Newly diagnosed with cancer
- •Non-insulin-dependent Type 2 diabetes
- •Awaiting surgery for cancer
排除标准
- •Medical contraindication to engage in physical activity
结局指标
主要结局
Changes in Short Physical Performance Battery (SPPB) at different time points from baseline to 1 year after surgery
时间窗: upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery
Group of measures that combines the results of the gait speed, chair stand and balance tests, with scores ranging from 0 (worst performance) to 12 (best performance).
次要结局
- Changes in fasting glucose at different time points from baseline to 1 year after surgery(upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery)
- Changes in fasting insulin at different time points from baseline to 1 year after surgery(upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery)
- Changes in BMI at different time points from baseline to 1 year after surgery(upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery)
- Changes in Patient Health Questionnaire-9 (PHQ-9) at different time points from baseline to 1 year after surgery(upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery)
- Changes in hip circumference at different time points from baseline to 1 year after surgery(upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery)
- Changes in waist circumference at different time points from baseline to 1 year after surgery(upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery)
研究者
Fernando Naclerio
Professor in Strength Training and Sports Nutrition
University of Greenwich