A Randomized Control Trial on the Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Length of Hospital Stay
研究概览
简要总结
This study aims to study the efficacy of a preoperative "bundle" of interventions, which consists of preoperative physiotherapy, nutritional support and cognitive exercises on elderly frail patients undergoing major abdominal surgery, and evaluating their outcomes. There will be two arms, intervention and control.
详细描述
Frailty is a geriatric syndrome, defined as an increased vulnerability to stressors leading to a state of decreased physiological resistance. It is characterised by a "constellation of symptoms and signs that describe the heterogeneous response of older adults to physiological and metabolic challenges." While frailty is not necessarily synonymous with chronological age, it is more prevalent among the older adult population and is associated with up to a threefold increased risk of mortality or major morbidity postsurgery. Thus, it has become critically important for healthcare systems to develop strategies designed to improve clinical outcomes in this high-risk population when undergoing surgeries.
Currently there is no clear intervention that has been proven to modify the syndrome of frailty or its impact on postoperative outcomes. This study investigates a novel multidisciplinary approach that can be implemented within a short time frame prior to surgery.
We plan to study the efficacy of a preoperative "bundle" of interventions, which consists of preoperative physiotherapy, nutritional support and cognitive exercises on elderly frail patients undergoing major abdominal surgery, and evaluating their outcomes based 1) length of hospital stay 2) Functional recovery from surgery 3) post-operative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients attending the Preoperative Evaluation Clinic, SGH at least 11 days prior to his/her elective major abdominal surgery. Major abdominal surgery is defined as an intraperitoneal surgery with expected length of stay beyond 2 days. For patients who attended the clinic more than 11 days prior to surgery date, they will be informed to start their prehabilitation bundle 10 days prior to surgery.
- •Aged 65 and above
- •Diagnosed as frail based on Fried criteria score 3and above
- •Able to understand and follow the prescribed cognitive and physical exercise
排除标准
- •Patients with Parkinson disease, previous stroke, neuromuscular disorders and those taking carbidopa/levodopa, donepezil hydrochloride or antidepressants as previous studies have found that these medications may cause symptoms that are similar with domains of frailty.
- •Patients who are not able to communicate
研究组 & 干预措施
Intervention
In the interventional arm, patients will be given:
- A 'Threshold' Inspiratory Muscle Trainer
- A nutritional assessment: if needed, dietary supplements prescribed (i.e Ensure, Glucerna).
- Cognitive exercise in the form of the 'Memory' card game will be taught to the patients and the caregiver (if available), to be done twice a day.
Patients will be provided with a protocol activities log and a study assistant will be conducting a telephone conversation on day 1, 4 and 7 to encourage compliance to the protocol and answer any queries with regards to the research study.
干预措施: Ensure, Resource 2.0 and Glucerna (Dietary Supplement)
Intervention
In the interventional arm, patients will be given:
- A 'Threshold' Inspiratory Muscle Trainer
- A nutritional assessment: if needed, dietary supplements prescribed (i.e Ensure, Glucerna).
- Cognitive exercise in the form of the 'Memory' card game will be taught to the patients and the caregiver (if available), to be done twice a day.
Patients will be provided with a protocol activities log and a study assistant will be conducting a telephone conversation on day 1, 4 and 7 to encourage compliance to the protocol and answer any queries with regards to the research study.
干预措施: Cognitive Training, Memory Card Game (Other)
Intervention
In the interventional arm, patients will be given:
- A 'Threshold' Inspiratory Muscle Trainer
- A nutritional assessment: if needed, dietary supplements prescribed (i.e Ensure, Glucerna).
- Cognitive exercise in the form of the 'Memory' card game will be taught to the patients and the caregiver (if available), to be done twice a day.
Patients will be provided with a protocol activities log and a study assistant will be conducting a telephone conversation on day 1, 4 and 7 to encourage compliance to the protocol and answer any queries with regards to the research study.
干预措施: 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc (Device)
Control
In the control arm, patients will be given the standard education materials regarding surgery and carry out daily activities as usual until the admission of the surgery.
结局指标
主要结局
Length of Hospital Stay
时间窗: Will be compared between the intervention and control arms for up to 1 year
次要结局
- Post operative complications(Duration of hospital admission for up to 30 days)
- Functional Post Operative Recovery(Duration of hospital admission for up to 30 days)