Pilot Testing Prehabilitation Services Aimed at Improving Outcomes of Frail Veterans Following Major Abdominal Surgery

试点康复服务旨在改善体弱的退伍军人在接受重大腹部手术后的结果

• 批准号: 9291841
• 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: 2017-01-01 至 2018-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9291841
• 关键词: Abdomen; Abdomen; Age; Age; Aged, 80 and over; Aged, 80 and over; Balance training; Balance training; Cardiac; Cardiac; Cardiac rehabilitation; Cardiac rehabilitation; Caring; Caring; Chest; Chest; Clinic; Clinic; Clinical; Clinical; Comorbidity; Comorbidity; Consultations; Consultations; Data; Data; Development; Development; Disease; Disease; Elderly; Elderly; Enrollment; Enrollment; Environmental Risk Factor; Environmental Risk Factor; Geriatrics; Geriatrics; Goals; Goals; Habilitation; Habilitation; Healthcare Systems; Healthcare Systems; Home environment; Home environment; Independent Living; Independent Living; Infrastructure; Institutionalization; Institutionalization; Intervention; Intervention; Investigation; Investigation; Length of Stay; Length of Stay; Letters; Life; Life; Long-Term Care; Long-Term Care; Measures; Measures; Medical; Medical; Methods; Methods; Morbidity - disease rate; Morbidity - disease rate; Muscle; Muscle; Muscular Atrophy; Muscular Atrophy; Nutrition Assessment; Nutrition Assessment; Nutritional; Nutritional; Operative Surgical Procedures; Operative Surgical Procedures; Orthopedics; Orthopedics; Outcome; Outcome; Participant; Participant; Patient risk; Patient-Focused Outcomes; Patient-Focused Outcomes; Patients; Patients; Perioperative; Physical Performance; Physical Performance; Physical activity; Physical activity; Physiological; Physiological; Pilot Projects; Pilot Projects; Population; Population; Postoperative Period; Postoperative Period; Prealbumin; Prealbumin; Procedures; Procedures; Randomized; Randomized; Randomized Controlled Trials; Randomized Controlled Trials; Recovery; Recovery; Recruitment Activity; Regimen; Regimen; Research; Research; Research Infrastructure; Research Personnel; Research Personnel; Risk; Risk; Schedule; Schedule; Services; Services; Standardization; Standardization; Stress; Stress; Supplementation; Supplementation; Surgeon; Surgeon; Syndrome; Syndrome; System; System; Testing; Testing; Time; Time; Training; Training; Urologic Surgical Procedures; Urologic Surgical Procedures; Veterans; Veterans; Work; Work; base; base; cohort; cohort; cost; cost; design; design; exercise training; exercise training; exhaustion; exhaustion; experience; experience; frailty; frailty; health related quality of life; health related quality of life; improved; improved; improved outcome; improved outcome; innovation; innovation; interest; interest; mortality; mortality; mortality risk; novel; novel; nutrition; nutrition; nutritional supplementation; nutritional supplementation; pedometer; perioperative mortality; post-operative rehabilitation; post-operative rehabilitation; pressure; pressure; pulmonary function; pulmonary function; recruit; rehabilitation strategy; rehabilitation strategy; statistics; statistics; strength training; strength training; success; success; surgery outcome; surgical risk

Background: Frail Veterans are at increased risk for poor surgical outcomes. Although surgeons operate safely on even the oldest old, if the elder is also frail, the stress of surgery can result in significant mortality, morbidity, and institutionalization. Frailty is a clinical syndrome marked by muscle atrophy, diminished strength, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age, and 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 and more frail, it is critically important to identify effective strategies for improving the surgical outcomes of these 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, improving nutrition, and optimizing home supports. Based on this success, there is growing interest in deploying similar interventions before surgery in what some call “prehabilitation.” By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of both surgery and recovery. Frail patients will likely benefit disproportionately from prehabilitation because they have the most diminished capacity to adapt to the stress of surgery. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations. Objectives: We will examine the feasibility of a novel, multifaceted pre-habilitation intervention aimed at improving postoperative outcomes for frail Veterans undergoing major abdominal surgery. Specific aims are to: (1) Estimate rates of recruitment, randomization, retention, and compliance with the prehabilitation intervention; (2) Measure (a) physical performance, (b) pulmonary function, and (c) nutrition at baseline and 2-week intervals to estimate changes over time and explore the optimal duration of prehabilitation (2 vs. 4 vs. 6 weeks); and (3) Estimate overall and treatment-specific summary statistics for postoperative outcomes in terms of 30- and 90-day (a) mortality, (b) major complications, (c) length of hospital stay, (d) health-related quality of life, (e) quality of surgical care, and (f) change in level of independent living. Methods: This randomized pilot study will enroll a consecutive cohort of up to 50 Veterans identified as frail using a standardized frailty assessment and scheduled for major abdominal surgery on the general or urological surgery services at the VA Pittsburgh Healthcare System. We will randomize participants 1:1 to receive either: (1) standard preoperative optimization by the Interdisciplinary Medical Preoperative Assessment Consultation & Treatment Clinic (IMPACT), or (2) prehabilitation + standard IMPACT optimization. The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation. Assessments will include standard postoperative outcomes as well as the Short Physical Performance Battery to measure physical performance, Maximal Inspiratory Pressure to measure pulmonary function, and both prealbumin and the 7-point Subjective Global Assessment to measure nutrition. Outcomes will be assessed 30 or 90 days after surgery. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will inform the development of a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the as many as 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。虽然外科医生 即使是最年长的老人，如果老人也很虚弱，手术的压力可能导致显著的死亡率， 发病率和制度化。虚弱是一种临床综合征，其特征是肌肉萎缩，力量减弱， 体力活动减少和疲惫它与任何特定疾病无关，但随着年龄的增长而增加， 并且是围手术期死亡率、发病率、住院时间和费用增加的更有力的预测因子， 仅基于年龄或合并症的预测。随着退伍军人和美国人口年龄的增长和更加虚弱， 对于确定改善这些患者手术结果的有效策略至关重要。 “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、改善营养和优化家庭支持来改善结果。基于此 成功后，人们越来越有兴趣在手术前部署类似的干预措施， “先知”通过改变生理和环境风险，prehistory旨在增加患者的 补偿手术和恢复压力的能力。虚弱的患者可能会受益 因为他们适应压力的能力最弱， 外科手术。然而，尚未在退伍军人或特别虚弱的人群中研究早产。 目的：我们将研究一种新颖的、多方面的预防性干预的可行性， 改善接受腹部大手术的虚弱退伍军人的术后结果。具体目标是： (1)估计招募率、随机化率、保留率和对预防干预的依从性; (2)在基线和2周时测量（a）体能，（B）肺功能和（c）营养 间隔来估计随时间的变化，并探索最佳的早产持续时间（2 vs. 4 vs. 6 周）;以及 (3)估计术后结局的总体和治疗特异性汇总统计量， 90-日（a）死亡率，（B）严重并发症，（c）住院时间，（d）健康相关生活质量，（e） 手术护理质量;（f）独立生活水平的变化。 方法：这项随机的初步研究将招募一个连续的队列，最多50名退伍军人被确定为体弱 使用标准化的虚弱评估，并安排在一般或 弗吉尼亚州匹兹堡医疗保健系统的泌尿外科服务。我们将以1：1的比例随机分配参与者， 接受：（1）通过跨学科医学术前评估进行标准术前优化 咨询和治疗诊所（IMPACT），或（2）prehistory+标准IMPACT优化。6周 长期的术前干预包括：（1）力量和平衡训练;（2）吸气肌训练; （3）营养指导和补充。评估将包括标准术后结局 以及用于测量体能的短体能测试组合，最大吸气量 测量肺功能的压力，以及前白蛋白和7分主观总体评估 来测量营养。将在手术后30或90天评估结局。遵守 将通过患者日志和步数计评估预给药方案。分析将告知 开展一项更大规模的随机对照试验，测试早产儿干预措施。数据的日期及时间为 每年有多达42，000名体弱的退伍军人计划进行重大选择性手术。