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

• 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
• 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

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.

远程缺血预适应(RIPC)在30年前首次被描述为一种干预措施 重要器官免受缺血损伤。当组织短暂缺血(5分钟)时，就会发生RIPC 在较长时间的缺血性损伤之前重复发作(5次)。最近，它被展示了锻炼的表现 年轻、健康的人在手臂或腿上进行RIPC时，使用 一个简单的血压袖带，用来阻断肢体的血液流动。RIPC在减少的个体中的应用 然而，功能性产能在很大程度上还没有得到开发。我们小组是第一个将RIPC应用于慢性中风的人 身体功能减退的幸存者和两周的RIPC提高了步行速度，麻痹了肌肉 强度和抗疲劳性。高龄和癌症都是虚弱的戏剧性加速器 患者的手术结果很差。因此，我们建议将这种非侵入性、简单的干预应用于 老年结肠癌患者围手术期的“康复”治疗。我们将招收96人 年龄55-85岁的结肠癌患者，在结肠癌手术前17天接受≥。之后 在研究登记时，所有参与者都将进行6分钟的步行测试，以此作为脆弱程度的衡量标准。参与者将 然后随机在手术前14天每天在他们的上臂、非优势臂上接受RIPC， 或接受标准护理(无干预)。在RIPC或不干预14天后，6分钟 步行测试将在手术后48小时内重新评估。我们的主要研究结果将是六年内的差异- RIPC组患者与标准护理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6分钟的步行测试中，组将比标准护理组走得更远，因为 RIPC对改善健康人的运动成绩、心血管功能和力量的明确效果 个人。第二项研究结果将是RIPC和RIPC之间6分钟步行测试距离的差异 和标准护理组术后4周(目标2)。我们假设RIPC组的患者 从手术中恢复得更快，这将从术后步行耐力的增加中得到证明。 从操作上讲。另一个次要研究结果将是术中血压变异性的大小。 RIPC和对照组之间(时间收缩压分别高于或低于135 mm Hg或95 mm Hg) 分组(目标3)。我们假设RIPC将由于井的原因降低术中血压变异性 描述了RIPC改善全身血管功能的效果。未来更大规模的研究将检验这些影响。 RIPC康复对老年虚弱患者住院时间和全因死亡率等手术结果的影响 结肠癌患者以及其他功能能力降低的患者队列。