Prehab-COG: Does Preoperative Exercise Improve Postoperative Cognitive Outcomes? (Prehab-COG)
Prehab-COG: Does Preoperative Exercise Improve Postoperative Cognitive Outcomes? A Pilot Study.
The purpose of this protocol is to evaluate the feasibility and acceptability of a preoperative exercise intervention (Prehabilitation) program, along with intraoperative Electroencephalography (EEG) recordings, and pre and post operative cognitive testing in older patients undergoing a major surgery.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Stanford、California、美国、94305
- Stanford Healthcare Centers
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults patients (50 years old or older).
- Scheduled to undergo non-cardiac or non-neurological surgery under general anesthesia.
- Plan to be admitted to the hospital after surgery for a minimum of one night.
- ASA physical status classification I to III.
- English or Spanish fluency (Cognitive testing only validated to be used with English or Spanish speakers).
Exclusion Criteria:
- Not able to understand/speak English or Spanish
- Failure to satisfy adequate hearing test with/without hearing aids.
- Visual impairment.
- Unplanned ICU admission after surgery.
- Patients who are undergoing another intervention study that consists of a cognitive or exercise intervention.
- Inability to provide consistent EEG data of sufficient quality, determined at enrollment.
- Subjects with medical conditions including but not limited to: Angina pectoris, Congestive Heart Failure (CHF) that make it dangerous for unsupervised physical activity, cognitive and psychiatric conditions that may affect ability to consent.
- Subjects who have contraindications to unsupervised exercise including but not limited to fall risks, movement disorders, and those who are on ambulatory oxygen therapy.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Moderate Exercise Arm
The participants will undergo the virtual exercise intervention 2xweek for 3-4 weeks prior to surgery, and take cognitive testing with non-invasive EEG recordings at 5-point time (the baseline prior to start of the exercise program, at 2-4 days prior to surgery, during the surgery, post-op, and 30-day post surgery). Participants will also be interviewed after the intervention and after surgery to obtain their feedback on their experience with the study procedures. |
Eligible participants will receive their exercise program, relevant informational material and training. The exercise program will be tailored to the physical fitness of the participants. The 2xweek virtual sessions take 30 minutes each and include guided exercises at mild-moderate intensity. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluate the feasibility of a preoperative home-based exercise intervention program, with intraoperative EEG recording, and pre and post operative cognitive testing, among older patients undergoing major surgery.
大体时间:Maximum 3 months from participant enrollment to end/completion of all study-related tasks.
|
Feasibility will be measured by:
|
Maximum 3 months from participant enrollment to end/completion of all study-related tasks.
|
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Evaluate the acceptability of a preoperative home-based exercise intervention program, with intraoperative EEG recording, and pre and post operative cognitive testing, among older patients undergoing major surgery.
大体时间:Maximum 3 months from participant enrollment to end/completion of all study-related tasks.
|
Acceptability will be measured by: 1) Aggregated (mean) Score of Surveyed Participants' Rating Across Each Study-Task (Average score of participants' ratings across study tasks, including exercise program, EEG recording and cognitive testing). |
Maximum 3 months from participant enrollment to end/completion of all study-related tasks.
|
合作者和调查者
调查人员
- 研究主任:Cindy Kin, MD、Stanford University
- 首席研究员:Patrick Purdon, PhD、Stanford University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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