Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients (HEROS) - a Pilot Interventional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery
研究概览
简要总结
Aims:
Clinical frailty severely impacts the physical, functional and physiological reserves necessary for the recovery after surgery. Sarcopenia, a multifactorial, multi-organ process which lead to loss of muscle mass over time, eventually resulting in clinical frailty. These 2 entities result in an increased morbidity and mortality from surgery. They also lead to a slower recovery from surgery with some patients never reaching baseline function after their surgery. It is, therefore, important to optimize patients with sarcopenia prior to surgery to reduce the incidence of morbidity and mortality.
Nutrition and resistance training have been shown to be able to curb the effects of sarcopenia. However, the type and regime of nutrition is still unknown.
Hypotheses:
The study team hypothesize that Ensure Plus Advance + HMB (beta-hydoxy-beta-methylbutyrate) would reduce the amount of IMAT (inter and intramuscular adipose tissue) in sarocpaenic patients after 2-4 weeks of prehabilitation. This effect would be sustained even after surgery and would continue to improve up to 3-months post-surgery whilst participating in rehabilitation. Taking Ensure Plus Advance + HMB would also improve functional parameters after prehabilitation, ensure a similar QoL 1-month post-surgery even if biochemical parameters may not show a significant improvement.
Methods:
The investigators would be conducting a pilot interventional cohort with an institution with an established prehabilitation programme (SKH) to evaluate the effect of the use a high protein, high calorie oral nutritional supplement (ONS) with HMB on muscle quality, using a device with Automated Intelligence (AI), in sarcopenic patients undergoing gastrointestinal surgery. Primary outcomes will be changes in Intermuscular Adipose Tissue (IMAT) while secondary outcomes include changes in functional parameters, quality-of-life (QoL), surgical outcomes and biochemical results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between 40-90 years old
- •are sarcopenia (defined by the Asian Workgroup of Sarcopenia 2019 definition)
- •due to undergo elective major gastrointestinal surgery
- •able to satisfy at least 2 weeks of prehabilitation before surgery
- •able to comply with physiotherapy and dietician advice
排除标准
- •Are pregnant
- •Are prisoners
- •Intellectually, mentally or emotionally deemed not able to provide an informed consent and/or are unable to fill up the post-procedure questionnaires
- •Have disease conditions requiring emergent/semi-emergent operation
- •Diabetes on oral hyperglycemic agents (OHGA)
- •Chronic Kidney Disease (CKD) or End-stage Renal Failure (ESRF)
- •Unable to or decline assessment for sarcopenia
结局指标
主要结局
change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery
时间窗: 1 day before surgery
change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery
次要结局
- Change of handgrip strength after the prehabilitation programme(1 day before surgery)
- change of Inter-muscular adipose tissue (%) from pre-surgery to 3-months post-surgery(3 months post surgery)
- Change of gait speed after the prehabilitation programme(1 day before surgery)
- change in average length of hospitalization(up to 30 days post surgery)
- change in quality of life measure (EuroQol-5D) at 1-, 2- and 3-months post-surgery(1,2 and 3 months post surgery)
研究者
Koh Hong Xiang Frederick
Principal Investigator, Consultant Colorectal Surgeon
Sengkang General Hospital