Functional Prehabilitation and Major Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Post-operative Functional Assessment
研究概览
简要总结
Purpose: To compare post-operative functional outcomes in patients undergoing preoperative functional prehabilitation versus standard of care preoperative management in older adults undergoing major elective operations.
Hypothesis: Older adults undergoing preoperative functional prehabilitation (nine sessions of home physical therapy over three weeks) will have improved physical function and reduced delirium in comparison to usual preoperative care following major abdominal and thoracic operations.
Specific Aims:
(#1) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the de Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical performance battery scores in the control and intervention groups at the preoperative and initial assessment timepoints.
(#2) To compare the difference in the timed up-and-go, Mini Mental Status Exam (MMSE), the de Morton Mobility Index, Modified Physical Performance Test (MPPT), and short physical performance battery scores in the control and intervention groups at the 60-days postoperative and the initial assessment timepoints.
(#3)To compare the rates of ICU delirium and need for post-discharge institutionalization in patients in the control and interventions groups.
(#4) To compare post-operative complications
详细描述
BACKGROUND Prehabilitation has been studied in relation outcomes after surgery. One common area studied is how it affects post-operative outcome for knee replacement patients. Prehabilitation was found to increase strength and function in older adults. {Swank, 2011. #1} Prehabilitation increased leg strength and the ability to perform functional tasks in these patients.
Prehabilitation has also been studied in patients undergoing coronary artery bypass graft surgery (CABG). Primary outcome measures were: anxiety and length of hospital stay; secondary outcome measures were: depression, physical functioning, cardiac misconceptions and cost utility. Prehabilitation was found to decrease depression and improve physical functioning. {Furze, 2009. #2}
Prehabilitation was also found in one study to reduce postoperative complications, length of stay, and declines in functional disability compared to the control group, while improving quality of life, in patients having cardiac and abdominal surgery. {Carli, 2005. #3}
No research has been done linking prehabilitation to the incidence of delirium. The research team has extensive experience studying delirium. Decreased cognition and functional ability has been linked to delirium and poorer outcomes post-operatively. {Robinson, 2009. #4}. Theoretically, by improving functional ability pre-operatively, post-operative outcomes will improve and delirium will decrease. This study will examine if this is true.
The current standard of care for abdominal and non-cardiac thoracic operations does not involve prehabilitation. (Cardiac operations were excluded due to the increased risk for heart-related complications during prehabilitation, such as Myocardial Infarction (MI).) The control group will receive standard of care pre-operative care, with the exception of baseline functional assessments.
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
- None
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 50 years and older undergoing major abdominal and non-cardiac thoracic operations with an anticipated postoperative ICU stay will be eligible for initial screening. A timed up-and-go assessment will be performed on all who individuals interested in participating. Individuals with a timed up-and-go score of greater than 10 seconds are eligible to participate.
- •Women and men will both be recruited for the study. Minorities and non-minorities will be recruited for the study.
排除标准
- •Participants under 50 years
- •Patients not going to the ICU post-operatively
- •Patients having a different kind of operation than major abdominal/non-cardiac thoracic
- •Those who complete the timed up-and-go in 10 seconds or less or
- •patients who cannot complete the timed up-and-go
- •Patients who cannot undergo informed consent
- •Patients with vision impairments who cannot visualize the pictures involved with the CAM-ICU
- •Patients who do not speak English will be excluded so that confusion created by a language barrier is not confused with post-operative delirium.
- •Pregnant women, prisoners, and decisionally challenged subjects.
结局指标
主要结局
Post-operative Functional Assessment
时间窗: 60 days post-operatively
Timed up-and-go score 60 days post operatively.
次要结局
- Post-operative complications(30 days post-operatively)
- Functional and mental battery scores postoperatively(60 days postoperatively)
- Discharge status(Discharge from hospital, expected to be 7 days)