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：尽管外科医生会进行手术，但体弱的退伍军人手术结果不佳的风险也会增加。 即使是最年长的老人也是安全的，如果老人也很虚弱，手术的压力可能会导致显着的死亡率， 衰弱是一种以肌肉萎缩、力量减弱为特征的临床综合征。 体力活动减少和疲劳与任何特定疾病无关，但随着年龄的增长而增加。 与围手术期死亡率、发病率、住院时间和费用相比，它是更强有力的预测因素 仅基于年龄或合并症的预测随着退伍军人和美国人的年龄增长和身体虚弱，它变得更加脆弱。 确定改善这些患者手术结果的有效策略至关重要。 先前的研究表明，“预康复”有可能改善体弱者的手术结果。 表明手术后采取的跨学科康复策略可以增强康复效果 在此基础上，通过增强力量、改善营养和优化家庭支持来改善结果。 成功后，人们越来越有兴趣在手术前采取类似的干预措施，有些人称之为 “预康复。”通过改变生理和环境风险，预康复旨在增强患者的能力 补偿手术和康复压力的能力可能会受益。 不成比例地来自预康复，因为他们适应压力的能力最弱 然而，尚未对退伍军人或特别虚弱人群进行预康复研究。 目标：我们将研究一种新颖的、多方面的康复前干预措施的可行性，旨在 改善接受大型腹部手术的体弱退伍军人的术后结果。 (1) 估计招募率、随机化、保留率以及预康复干预的依从性； (2) 测量基线和两周的 (a) 身体表现、(b) 肺功能和 (c) 营养 估计随时间变化的时间间隔并探索预康复的最佳持续时间（2 vs. 4 vs. 6 周）；和 (3) 根据 30 和 30 估计术后结果的总体和特定治疗的汇总统计数据 90 天 (a) 死亡率，(b) 主要并发症，(c) 住院时间，(d) 健康相关生活质量，(e) 手术护理质量，以及 (f) 独立生活水平的变化。 方法：这项随机试点研究将连续招募最多 50 名被确定为体弱的退伍军人 使用虚弱评估和预定的标准化来进行一般或常规的腹部大手术 VA 匹兹堡医疗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。 接受以下任一操作：(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) 预康复 + 标准 IMPACT 优化 6 周。 长期预康复干预将包括（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果。 以及用于测量身体表现的短身体表现电池、最大吸气 测量肺功能、前白蛋白和 7 点主观总体评估的压力 将在手术后 30 或 90 天评估结果。 将通过患者日志和计步器评估预康复方案。 将开展一项更大规模的随机对照试验来测试康复干预的结果。 每年有多达 42,000 名体弱的退伍军人计划接受重大择期手术。