COgnitive and Physical Exercise (COPE) Prehabilitation to Improve Outcomes in Surgical Patients: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Participation log and diary
研究概览
简要总结
Cognitive and functional impairment are debilitating problems for survivors of major surgery. Efforts to modify medical treatments to prevent such impairment are ongoing and may yet yield significant benefits. An area in need of study is whether building patients' cognitive and physical reserve through a prescribed program of cognitive and physical exercise before the physiological insult (a prehabilitation effort) can improve long-term outcomes. Prehabilitation efforts before surgery thus far have focused on preemptive physical therapy to improve post-surgical functional outcomes. No work, however, has been done to attenuate the cognitive decline commonly seen after surgical illness by exercising the brain before the surgical insult. Cognitive prehabilitation is a novel therapeutic approach that applies well-understood techniques derived from brain plasticity research. Our approach is bolstered by data that demonstrate that cognitive training programs are effective and have a very high likelihood of fostering improvement in patient outcomes across a range of populations. It is not yet known if these programs can improve cognitive reserve, allowing patients' minds to better manage the acute stress of surgery and hospitalization. The primary aim of this pilot study is to evaluate the feasibility of cognitive and physical prehabilitation training in adult patients undergoing major non-cardiac surgery who are at risk for postoperative cognitive and functional decline. The secondary aim is to study the effects of cognitive and physical prehabilitation training on cognitive abilities, functional status, and quality of life after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adults undergoing major surgery with the likelihood of prolonged hospitalization or critical illness among the following surgical services: general surgery, surgical oncology, otolaryngology, hepatobiliary, thoracic, and vascular surgery
排除标准
- •Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform the proposed cognitive and physical program
- •Pregnancy
- •Prisoners
- •Severe frailty or physical impairment that prohibits participation in prehabilitation program
- •Patients with documented dementia or cognitive impairment that precludes ability to self-consent for surgery and study participation
- •Less than 2 weeks from scheduled surgery
- •Patients without home internet access
研究组 & 干预措施
Control
The active attention control group will receive a binder with information about personal health including sleep hygiene, nutritional changes, and stress reduction. In addition, they will participate in a control version of the cognitive training program. They will receive weekly phone calls by cognitive and physical therapy teams to address issues with any aspects of the program.
干预措施: Active attention control (Other)
Cognitive and physical prehabilitation
The intervention group will receive the prehabilitation program consisting of a guided progressive program of home-based aerobic and resistance training exercise, which will be adapted based on kinesiologist recommendation for each individual and the individual's perceived exertion. In addition, they will have access to the full cognitive training program. They will receive weekly phone calls by cognitive and physical therapy teams to address issues with any aspects of the program.
干预措施: Cognitive and physical prehabilitation (Behavioral)
结局指标
主要结局
Participation log and diary
时间窗: From date of randomization to surgery, approximately 4 weeks
Proportion of eligible days that patients performed the cognitive and physical prehabilitation program, duration of time per day patients spent on each program
次要结局
- Hospital length of stay(From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days)
- Pain levels(During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up)
- Activities of daily living(Approximately 1 month after surgery at the post-surgical clinic follow-up)
- Instrumental activities of daily living(Approximately 1 month after surgery at the post-surgical clinic follow-up)
- Discharge location(From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days)
- Cognitive assessment(Approximately 1 month after surgery at the post-surgical clinic follow-up)
- Muscle strength(Approximately 1 month after surgery at the post-surgical clinic follow-up)
- Functional exercise capacity(Approximately 1 month after surgery at the post-surgical clinic follow-up)
- Pulmonary function(Approximately 1 month after surgery at the post-surgical clinic follow-up)
- Acute brain dysfunction(During hospital stay after surgery, for up to 2 weeks)
研究者
Christopher Hughes
Associate Professor of Anesthesiology
Vanderbilt University