改善重症监护病房后的每日康复及预后（IMPROVE）：一项随机对照试验的研究方案
Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.
作者信息
Wang Sophia, Hammes Jessica, Khan Sikandar, Gao Sujuan, Harrawood Amanda, Martinez Stephanie, Moser Lyndsi, Perkins Anthony, Unverzagt Frederick W, Clark Daniel O, Boustani Malaz, Khan Babar
机构信息
Department of Psychiatry, Indiana University School of Medicine, 355 W 16th Street, Suite 4800 GH, Room 4250, Indianapolis, IN, 46202, USA.
Center of Health Innovation and Implementation Science, Center for Translational Science and Innovation, Indianapolis, IN, USA.
出版信息
Trials. 2018 Mar 27;19(1):196. doi: 10.1186/s13063-018-2569-8.
BACKGROUND
Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE.
METHODS
IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation.
DISCUSSION
This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms of action.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03095417 . Registered on 23 March 2017. Last updated on 15 May 2017.
背景
谵妄影响了近70%入住重症监护病房（ICU）的老年人，其中许多人将遗留持续性认知障碍或痴呆。目前尚无有效且可扩展的康复模式来纠正ICU获得性认知障碍及其伴随的痴呆或阿尔茨海默病（AD）风险升高。ICU后每日改善康复与结局（IMPROVE）试验是一项正在进行的临床试验，旨在评估体育锻炼与认知训练相结合对50岁及以上在ICU住院期间发生谵妄的ICU幸存者认知功能的疗效。本文描述了IMPROVE的研究方案。
方法
IMPROVE是一项四臂随机对照试验。受试者将被随机分为四组之一：认知训练与体育锻炼；认知对照与体育锻炼；认知训练与体育锻炼对照；认知对照与体育锻炼对照。促进者通过使用支持互联网的视频会议以个体和小组形式实施体育锻炼和锻炼对照干预。认知训练和对照干预也由促进者主导，使用Posit Science公司的在线模块，以个体和小组形式直接传送到参与者家中。受试者在基线、3个月和6个月时完成认知评估、情绪问卷、身体性能测试和生活质量量表。还将在基线和3个月时采集血样，以测量促炎细胞因子和急性期反应物；神经营养因子；以及神经胶质功能障碍和星形胶质细胞活化的标志物。
讨论
本研究是首个检验体育锻炼与认知锻炼相结合对伴有谵妄的老年ICU幸存者认知功能疗效的临床试验。研究结果将提供关于联合干预对一系列结局和作用机制的潜在协同效应的信息。
试验注册
ClinicalTrials.gov，NCT03095417。于2017年3月23日注册。最后更新于2017年5月15日。
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