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Prehabilitation of Frail Surgical Cancer Patients using Remote Ischemic Preconditioning

使用远程缺血预处理对体弱的外科癌症患者进行预康复

基本信息

批准号：
9896751
负责人：
Matthew Durand
金额：
$ 20.7万
依托单位：
MEDICAL COLLEGE OF WISCONSIN
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-04-01 至 2022-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9896751
关键词：
Activities of Daily Living Adherence Advanced Malignant Neoplasm Age Animal Model Athletic Blood Pressure Blood Vessels Blood flow Cancer Patient Cardiovascular Physiology Cardiovascular system Clinical Clinical Trials Colon Carcinoma Control Groups Data Elderly Endothelium Enrollment Equipment Excision Exercise Exhibits Extensor Fatigue Frail Elderly Future Healthcare Systems Home environment Hour Human Individual Intervention Ischemia Ischemic Preconditioning Knee Laboratories Leg Length of Stay Limb structure Literature Malignant Neoplasms Measures Morbidity - disease rate Multi-Institutional Clinical Trial Muscle Muscle Fatigue Muscle function Neoadjuvant Therapy Neurologic Operative Surgical Procedures Organ Outcome Study Output Paresis Participant Patient Care Patient-Focused Outcomes Patients Performance Perfusion Perioperative Phase Physical Fitness Physical Function Physical activity Physiological Population Postoperative Complications Postoperative Period Preoperative Care Randomized Recovery Recovery of Function Rehabilitation therapy Resistance Risk Running Schedule Single-Blind Study Site Skeletal Muscle Stimulus Stress Systolic Pressure Techniques Testing Time Tissues Walking Work aged aging population arm attenuation blood pressure variability cardioprotection chemotherapy chronic stroke cohort colon cancer patients comorbidity cost effective disability efficacy testing exercise regimen frailty improved intervention cost ischemic injury limb ischemia meter mortality motor function improvement motor learning muscle strength negative affect older patient patient population postoperative recovery programs prospective response secondary outcome sedentary standard of care stroke survivor surgery outcome surgical risk walking speed

项目摘要

Remote ischemic preconditioning (RIPC) was first described three decades ago as an intervention to protect vital organs from ischemic injury. RIPC occurs when a tissue is made transiently ischemic (5 minutes) for repeated bouts (5 times) prior to the longer ischemic insult. Recently it has been shown exercise performance and motor function are improved in young, healthy individuals when RIPC is performed on the arm or leg using a simple blood pressure cuff to occlude blood flow to the limb. The application of RIPC to individuals with reduced functional capacity, however, is largely unexplored. Our group was the first to apply RIPC to chronic stroke survivors with reduced physical function, and two weeks of RIPC increases walking speed, paretic muscle strength and fatigue resistance. Advanced age and cancer are both dramatic accelerators of frailty and frail patients have poor surgical outcomes. Therefore, we propose to apply this non-invasive, simple intervention as a “prehabiliative” therapy to elderly patients with colon cancer during the perioperative period. We will enroll 96 colon cancer patients aged 55-85 who are ≥17 days prior to scheduled curative resection of colon cancer. After study enrollment, all participants will perform the six-minute walk test as a measure of frailty. Participants will then be randomized to receive either RIPC on their upper, non-dominant arm daily for 14 days prior to surgery, or to receive standard of care (no intervention). After 14 days of either RIPC or no intervention, the 6-minute walk test will be re-assessed within 48 hours of surgery. Our primary study outcome will be the difference in six- minute walk distance (in meters) between patients in the RIPC group vs. those in the standard of care group following the two-week pre-operative intervention period (Aim 1). We hypothesize that patients in the RIPC group will walk further during the six-minute walk test than those in the standard of care group due to the well- defined effects of RIPC to improve athletic performance, cardiovascular function, and strength in healthy individuals. A secondary study outcome will be the difference in six-minute walk test distance between the RIPC and standard of care group 4-weeks postoperatively (Aim 2). We hypothesize that patients in the RIPC group will have more rapid recovery from surgery, which would be evidenced by increased walking endurance post- operatively. Another secondary study outcome will be the amount of intraoperative blood pressure variability (time systolic pressure is above or below 135 mmHg or 95 mmHg, respectively) between the RIPC and control groups (Aim 3). We hypothesize that RIPC will reduce intraoperative blood pressure variability due to the well described effects of RIPC to improve systemic vascular function. Future larger studies will examine the effects of RIPC prehabilitation on surgical outcomes such as length of hospital stay and all-cause mortality in frail, elderly patients with colon cancer as well as other patient cohorts with reduced functional capacity.

远程缺血预处理（RIPC）是三十年前首次描述的一种干预措施，重要器官的缺血性损伤当组织短暂缺血（5分钟）在较长的缺血性损伤之前重复发作（5次）。最近它的运动表现在年轻、健康的个体中，当在手臂或腿部进行RIPC时，一个简单的血压袖带来阻断流向肢体的血液。RIPC在减少的个体中的应用然而，功能能力在很大程度上尚未得到探索。我们小组是第一个将RIPC应用于慢性中风的研究小组。身体功能下降的幸存者，两周的RIPC增加了行走速度，强度和抗疲劳性。高龄和癌症都是脆弱和虚弱的戏剧性加速器患者的手术效果不佳。因此，我们建议采用这种非侵入性的简单干预，老年结肠癌患者围手术期的“预消化”治疗。我们将招收96名年龄55-85岁的结肠癌患者，在计划的结肠癌根治性切除术前≥17天。后研究入组后，所有参与者都将进行6分钟步行测试，作为虚弱程度的测量。参与者将然后在手术前14天内，随机在其上臂、非优势臂每日接受RIPC，或接受标准护理（无干预）。经过14天的RIPC或无干预后，6分钟将在手术后48小时内重新评估步行试验。我们的主要研究结果将是六个方面的差异- RIPC组与标准治疗组患者之间的分钟步行距离（米）术后两周的术前干预期（目标1）。我们假设RIPC中的患者在六分钟步行测试期间，组将比标准护理组中的那些人走得更远，这是由于良好的- RIPC对改善健康人的运动表现、心血管功能和力量的明确作用个体次要研究结果将是RIPC与对照组之间6分钟步行测试距离的差异。术后4周标准治疗组（目标2）。我们假设RIPC组的患者将有更快的恢复手术，这将证明增加步行耐力后，有效地另一个次要研究结果是术中血压变异性的数量 (time收缩压分别高于或低于135 mmHg或95 mmHg （目标3）。我们假设RIPC将降低术中血压变异性，描述了RIPC改善全身血管功能的作用。未来更大规模的研究将检验 RIPC对手术结果的影响，如住院时间和体弱，老年人的全因死亡率，结肠癌患者以及其他功能能力降低的患者群体。