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首页> 外文OA文献 >Critical Care Cycling Study (CYCLIST) trial protocol: A randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill
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Critical Care Cycling Study (CYCLIST) trial protocol: A randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill

机译：重症监护骑自行车研究（CYCLIST）试验方案：常规护理的随机对照试验，以及重症患者常规卧床护理与常规护理的比较

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\ud\udIn-bed cycling with patients with critical illness has been shown to be safe and feasible, and improves physical function outcomes at hospital discharge. The effects of early in-bed cycling on reducing the rate of skeletal muscle atrophy, and associations with physical and cognitive function are unknown.\ud\ud\ud\udA single-centre randomised controlled trial in a mixed medical-surgical intensive care unit (ICU) will be conducted. Adult patients (n=68) who are expected to be mechanically ventilated for more than 48 hours and remain in ICU for a further 48 hours from recruitment will be randomly allocated into either (1) or (2) . The primary outcome is change in rectus femoris cross-sectional area at day 10 in comparison to baseline measured by blinded assessors. Secondary outcome measures include muscle strength, incidence of ICU-acquired weakness, handgrip strength, time to achieve functional milestones (sitting out of bed, walking), Functional Status Score in ICU, ICU Mobility Scale, 6 min walk test 1 week post-ICU discharge, incidence of delirium and quality of life (EuroQol Five Dimensions questionnaire Five Levels scale). Quality of life assessments will be conducted post-ICU admission at day 10, 3 and 6 months after acute hospital discharge. Participants in the intervention group will complete an acceptability of intervention questionnaire.\ud\ud\ud\udAppropriate ethical approval from Metro South Health Human Research Ethics Committee has been attained. Results will be published in peer-reviewed publications and presented at scientific conferences to assist planning of future multicentre randomised controlled trials (if indicated) that will test in-bed cycling as an intervention to improve the physical, cognitive and health-related quality of life outcomes of patients with critical illness.
机译：已证明对重症患者进行卧床骑行是安全可行的，并且可以改善出院时的身体机能。床前早期骑自行车对减少骨骼肌萎缩的速度以及与身体和认知功能的关系的影响尚不清楚。\ ud \ ud \ ud \ ud混合医疗-外科重症监护室中的单中心随机对照试验（ICU）。预计将在招募后机械通气超过48小时并在ICU中停留48小时以上的成年患者（n = 68）被随机分配到（1）或（2）中。主要结果是与盲法评估者测量的基线相比，第10天的股直肌横截面积变化。次要结局指标包括肌肉力量，ICU获得性无力的发生率，握力，达到功能里程碑的时间（坐下床，步行），ICU中的功能状态评分，ICU行动量表，ICU后1分钟步行6分钟步行测试出院，of妄的发生率和生活质量（EuroQol五维度问卷五级量表）。急性出院后第10、3和6个月，ICU入院后将进行生活质量评估。干预组的参与者将完成干预问卷的可接受性。\ ud \ ud \ ud \ ud已获得Metro South Health Human Research Ethics Committee的适当伦理批准。研究结果将发表在同行评审的出版物中，并在科学会议上发表，以协助规划未来的多中心随机对照试验（如果有），该试验将测试床内自行车作为干预措施，以改善与身体，认知和健康有关的生活质量重症患者的预后。

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