Pilot testing a home-based rehabilitation intervention designed to improve outcomes of frail Veterans following cardiothoracic surgery

背景：虚弱的退伍军人手术结果不佳的风险增加。尽管外科手术技术 已经达到了可以对高龄成年人进行手术的水平，如果患者也很虚弱， 手术可能使他们的适应能力不堪重负，使他们面临更高的死亡率、发病率和 即使手术在技术上是成功的。虚弱是一种常见的临床综合征。 肌肉萎缩的以肌肉萎缩、力量和速度减弱、体力活动减少和精疲力竭为特征的 它独立于任何特定的疾病，但它随着年龄的增长而增加，并通过以下方式恶化疾病预后 承受压力源的能力减弱。因此，尽管手术通常适用于年龄较大的患者，但身体虚弱 与健壮的同行相比，候选人不太可能容忍该程序和/或恢复功能能力。 事实上，最近的VA数据表明，虚弱是围手术期死亡率增加的更有力的预测指标， 发病率、住院时间和费用比仅基于年龄或合并症的预测要好。作为老兵和美国 人口老龄化，脆弱性将增加，因此确定有效的战略以应对 改善虚弱患者的手术恢复和预后。 “康复训练”有可能改善体弱者的手术结果。前期研究 表明手术后部署的跨学科康复策略可促进康复和 通过增强体力和改善营养来改善结果。基于这一成功，有越来越多的 对“康复”感兴趣，这是一种在手术前部署的类似干预措施。通过修改生理上的 和环境风险，康复治疗的目的是增强患者补偿压力的能力 手术本身和之后的恢复期。虚弱的患者可能不成比例地受益于 康复是因为他们承受手术和/或康复的能力减弱。初步 有证据表明，术前锻炼干预可以改善手术结果。然而， 康复训练尚未在退伍军人或特别虚弱的人群中进行研究，也没有先前的研究 使用以家庭为基础的康复战略，安全地将与旅行有关的参与障碍降至最低。 目标：我们将研究一种新颖的、多方面的、基于家庭的康复干预的可行性。 旨在改善虚弱退伍军人的功能能力和术后预后 心胸外科手术。具体目标是： (1)估计招募、保留和遵守干预措施的比率；并评估参与情况 障碍。 (2)测量身体虚弱、身体功能、肺功能、营养和与健康有关的时间的变化 在基线、手术当天、手术后30天和90天的生活质量。 (3)探讨术后病死率、主要并发症、住院天数和住院时间的变化。 独立生活，使用病例匹配的历史对照。 方法：这项单臂试验性研究将招募最多30名被确认为虚弱的退伍军人的连续队列 使用标准化的脆弱性评估，并计划在VA匹兹堡进行主要的心胸手术 医疗保健系统。为期4周的康复方案将包括：(A)有氧调理，(B)力量 (C)呼吸肌训练；(D)营养指导和补充。 康复前后的评估将包括：(A)虚弱；(B)身体功能；(C)肺功能； (D)营养；和(E)与健康有关的生活质量。术后结果将包括住院时间、死亡率 和并发症。对康复方案的依从性将通过患者日志和 计步器。分析将为更大规模的随机对照试验提供信息，以测试康复干预。 这一发现将与每年计划接受重大择期手术的4.2万名虚弱退伍军人相关。

Background: Frail Veterans are at increased risk for poor surgical outcomes. Although surgical techniques have advanced to a level where surgery on very old adults is feasible, if a patient is also frail, the stress of surgery may overwhelm their adaptive capacities, placing them at increased risk of mortality, morbidity, and institutionalization even if surgery is technically successful. Frailty is a clinical syndrome that is commonly characterized by muscle atrophy, diminished strength and speed, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age and worsens disease prognoses by diminishing capacity to tolerate stressors. Thus, while surgery is often indicated for older patients, frail candidates are less likely than robust counterparts to tolerate the procedure and/or recover functional capacity. In fact, recent VA data demonstrate that frailty is a more powerful predictor of increased perioperative mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity alone. As the Veteran and US populations grow older, frailty will increase, making it critically important to identify effective strategies for improving the surgical recovery and outcomes of frail patients. “Prehabilitation” has the potential to improve surgical outcomes among the frail. Prior research demonstrates that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. Based on this success, there is growing interest in “prehabilitation”, which is a similar intervention deployed before surgery. By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of surgery itself and the convalescent period thereafter. Frail patients may benefit disproportionately from prehabilitation because they have diminished capacity to endure the procedure and/or recovery. Preliminary evidence suggests that preoperative exercise interventions improve surgical outcomes. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations, and no prior studies used home-based prehabilitation strategies to safely minimize travel-related barriers to participation. Objectives: We will examine the feasibility of a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Specific aims are to: (1) Estimate rates of recruitment, retention, and adherence to the intervention; and evaluate participation barriers. (2) Measure changes over time in frailty, physical function, pulmonary function, nutrition, and health-related quality of life at baseline, the day of surgery, and 30 and 90 days after surgery. (3) Explore changes in postoperative mortality, major complications, length of hospital stay, and level of independent living using case-matched historical controls. Methods: This single-arm pilot study will enroll a consecutive cohort of up to 30 Veterans identified as frail using a standardized frailty assessment and scheduled for major cardiothoracic surgery at the VA Pittsburgh Healthcare System. The 4 week long prehabilitation regimen will include: (a) aerobic conditioning, (b) strength and coordination training, (c) respiratory muscle training, and (d) nutritional coaching and supplementation. Pre- and post-prehabilitation assessments will include: (a) frailty; (b) physical function; (c) pulmonary function; (d) nutrition; and (e) health-related quality of life. Postoperative outcomes will include length of stay, mortality and complications. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will inform a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the 42,000 frail Veterans scheduled for major elective surgery each year.