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

试点测试一种家庭康复干预措施，旨在改善心胸外科手术后体弱退伍军人的预后

• 批准号: 9922125
• 负责人: Daniel E Hall
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-01 至 2020-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9922125
• 关键词: Abdomen; Activities of Daily Living; Adherence; Adult; Aerobic; Age; Cardiac; Caring; Chest; Clinical; Data; Day Surgery; Development; Disease; Enrollment; Environmental Risk Factor; Geriatrics; Healthcare Systems; Home environment; Hospitals; Hybrids; Independent Living; Institutionalization; Intervention; Length of Stay; Life; Long-Term Care; Lung; Measures; Methods; Morbidity - disease rate; Muscular Atrophy; Nutritional; Operative Surgical Procedures; Orthopedics; Outcome; Patients; Phenotype; Physical Function; Physical Performance; Physical activity; Physiological; Pilot Projects; Population; Postoperative Period; Prealbumin; Procedures; Randomized Controlled Trials; Recovery; Regimen; Rehabilitation Outcome; Rehabilitation therapy; Research; Respiratory Muscles; Risk; Schedule; Speed; Standardization; Stress; Supplementation; Syndrome; Techniques; Testing; Thoracic Surgical Procedures; Time; Training; Travel; Veterans; Walking; arm; base; cohort; comorbidity; conditioning; cost; design; exercise intervention; exercise training; exhaustion; frailty; health related quality of life; improved; improved outcome; indexing; innovation; interest; mortality; mortality risk; novel; nutrition; nutritional supplementation; older patient; pedometer; perioperative mortality; post-operative rehabilitation; programs; pulmonary function; recruit; rehabilitation strategy; stressor; success; surgery outcome; surgical risk; therapy design

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.

背景：虚弱的退伍军人手术效果差的风险增加。虽然手术技术 已经发展到一个水平，在非常老的成年人手术是可行的，如果病人也很虚弱， 手术可能会压倒他们的适应能力，使他们面临更高的死亡率，发病率和死亡率的风险。 即使手术在技术上是成功的。虚弱是一种临床综合征， 以肌肉萎缩、力量和速度下降、体力活动减少和疲惫为特征。 它独立于任何特定的疾病，但它随着年龄的增长而增加， 承受压力的能力下降。因此，虽然手术通常适用于老年患者，但虚弱的 候选者比健壮的对应者更不可能容忍该过程和/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因素， 发病率，住院时间和费用比基于年龄或合并症单独预测。作为退伍军人和美国 人口老龄化，脆弱性将增加，因此确定有效的战略至关重要， 改善虚弱患者的手术恢复和结果。 “Prehestival”有可能改善体弱者的手术结果。先前的研究 表明手术后部署的跨学科康复策略可促进恢复， 通过增强力量和改善营养来改善结果。基于这一成功， 对“早产儿”感兴趣，这是一种类似的手术前干预措施。通过改变生理 和环境风险，旨在增强患者的能力，以补偿压力， 手术本身和之后的康复期。虚弱的患者可能会不成比例地受益于 因为他们承受手术和/或康复的能力减弱。初步 有证据表明，术前运动干预可改善手术结果。然而，在这方面， 尚未在退伍军人或特别虚弱的人群中研究过早产儿， 使用基于家庭的预防策略，以安全地最大限度地减少与旅行有关的参与障碍。 目的：我们将研究一种新颖的、多方面的、以家庭为基础的早产儿干预的可行性 旨在改善虚弱退伍军人的功能能力和术后结果， 心胸外科手术具体目标是： (1)估计招募率、保留率和对干预措施的坚持率;并评估参与情况 隔栏. (2)测量虚弱、身体功能、肺功能、营养和健康相关方面随时间的变化 基线、手术当天、手术后30天和90天的生活质量。 (3)探讨术后死亡率、主要并发症、住院时间和 使用病例匹配的历史对照进行独立生活。 方法：这项单臂初步研究将招募一个连续队列，最多30名被确定为体弱的退伍军人 使用标准化的虚弱评估，并计划在VA匹兹堡进行重大心胸手术 医疗系统。为期4周的预训练方案将包括：（a）有氧训练，（B）力量训练 和协调训练，（c）呼吸肌训练，和（d）营养指导和补充。 术前和术后评估将包括：（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。术后结局将包括住院时间、死亡率 和并发症。将通过患者日志评估预治疗方案的依从性， 计步器分析结果将为一项更大规模的随机对照试验提供信息，以测试预防干预措施。 调查结果将与每年计划进行重大择期手术的42，000名虚弱的退伍军人有关。