Dose of Early Therapeutic Mobility: Does Type or Frequency of Activity Matter?

描述(由申请人提供)：早期治疗活动的剂量：活动的类型和频率重要吗？摘要早期治疗活动(ETM)被推荐用于促进康复和改善预后，特别是对于100万危重疾病幸存者。ETM活动的有效剂量(即类型、频率和持续时间)尚不清楚，有关ETM在机械通气重症监护病房(ICU)患者中的应用和效果的报道也有限。三种炎症标志物，白介素6、白介素10和C反应蛋白，可能被一次ETM活动改变。ETM也可能对身体健康的系统指标(即生命体征、精神错乱、肌肉力量、呼吸机相关性肺炎和机械通气时间)产生积极影响。这项跨学科研究的主要目的是比较每天单次和两次ETM活动的即时效果，以及低和中等类型的ETM活动对机械通气成人炎症分子生物标志物和身体健康系统标志物的影响。第二个目标是探索未来多点试验的方法和效果大小。这是一项准实验设计，采用重复测量；受试者将被随机分配，每天接受一或两次ETM活动，持续3天，然后在住院时间超过3天时每周接受一次ETM活动。ETM活动的类型将根据患者的情况而定，频率将是随机的。主要的研究问题是：(1A)炎性生物标志物IL(IL)-6、IL-10和C-反应蛋白(CRP)的ETM活动频率(每天一次和两次)之间的差异？(1B)炎性生物标志物IL-6、IL-10和CRP的ETM活动类型(低或中等)之间的差异？(2A)ETM活动对全身健康指标的差异：生命体征、精神错乱、肌肉力量、呼吸机相关性肺炎和机械通气天数？(2B)ETM活动类型对身体健康的系统指标：生命体征、精神错乱、肌肉力量、呼吸机相关性肺炎和机械通气持续时间有何不同？在这项初步研究中，将收集最多连续3天的ICU患者的数据，这些患者机械通气24小时，然后每周检查患者对ETM活动的短期反应。每日活动的插曲将由研究干预者提供。活动的类型将根据患者的情况而定，活动的频率将被随机分配，每天一到两次，患者在ICU。重复测量MANCOVA和ANCOVA将被用来回答研究问题。这项合作研究评估了跨学科团队中的生物行为方法，该方法与改善结果研究的生物行为方法(PA-07-008)和国家护理研究所基于证据改善治疗和健康的使命一致。公共卫生相关性：早期治疗活动可阻断病理性全身炎症。这项创新性的研究将考察ETM活动对接受机械通气的成人炎症生物标志物的影响。它首次调查了在重症监护病房中被动活动范围对患者康复的影响。分子和系统的健康标记物可用于指导床边临床医生实施和发展活动疗法。这项研究是研究机械通气患者ETM活动的最佳“剂量”的初步步骤，并有可能促进危重疾病的康复。

DESCRIPTION (provided by applicant): Dose of Early Therapeutic Mobility: Does Type and Frequency of Activity Matter? Abstract Early therapeutic mobility (ETM) activity has been recommended to facilitate recovery and improve outcomes, particularly for the one million survivors of critical illness. The effective dose (i.e., type, frequency and duration) of ETM activity is not known and there are limited reports about the application and effects of ETM in mechanically ventilated intensive care unit (ICU) patients. Three inflammatory biomarkers, interleukin (IL)-6, IL-10 and C-reactive protein, are potentially altered by a single episode of ETM activity. Systemic markers of physical health (i.e., vital signs, delirium, muscle strength, ventilator associated pneumonia, and length of time mechanically ventilated) may also be positively influenced by ETM. The primary aim of this interdisciplinary study is to compare the immediate effects of single and twice daily episodes of ETM activity and the effects of low and moderate types of ETM activity on molecular biomarkers of inflammation and systemic markers of physical health in mechanically ventilated adults. The secondary aim is to explore approaches and effect sizes for future multi-site trials. This is a quasi-experimental design, using repeated measures; subjects will be randomized to receive either one or two episodes of ETM activity daily for 3 days, then weekly when length of stay exceeds 3 days. Type of ETM activity will be determined by patient condition and frequency will be randomized. The primary research questions are: (1a) What are the differences between the frequency (once versus twice daily) of ETM activities on inflammatory biomarkers: interleukin (IL)-6, IL-10 and C-reactive protein (CRP)? (1b) What are the differences between the type (low or moderate) of ETM activities on inflammatory biomarkers: IL-6, IL-10 and CRP? (2a) What are the differences between frequency of ETM activities on systemic markers of physical health: vital signs, delirium, muscle strength, ventilator-associated pneumonia and days of mechanical ventilation? (2b) What are the differences between type of ETM activities on systemic markers of physical health: vital signs, delirium, muscle strength, ventilator-associated pneumonia and duration of mechanical ventilation? Data will be collected for a maximum of 3 contiguous days in ICU patients who are mechanically ventilated for >24 hours, then weekly to examine short-term patient responses to ETM activities in this preliminary study. Daily episodes of activity will be provided by a study interventionist. Type of activity will be determined by patient condition and frequency of activity will be randomized as once or twice daily each day the patient is in the ICU. Repeated measures MANCOVA and ANCOVA will be used to answer the research questions. This collaborative study evaluates a biobehavioral methodology within an interdisciplinary team consistent with the biobehavioral methods to improve outcome research (PA-07-008) and the mission of the National Institute of Nursing Research to improve treatments and health based on evidence. Public Health Relevance: Early therapeutic mobility may interrupt pathologic systemic inflammation. This innovative study will examine the impact of ETM activity on inflammatory biomarkers in adults receiving mechanical ventilation. It investigates for the first time the affect of passive range of motion on recovery in patients in the intensive care unit. Molecular and systemic markers of health may be used to guide the bedside clinician in implementing and progressing mobility therapy. This study is a preliminary step in the investigation of the optimal "dose" of ETM activity in mechanically ventilated patients and has the potential to improve recovery from critical illness.