Protein Optimization with Exercise to Improve Muscle Mass and Functional Outcomes (PROXIMUS)

通过运动优化蛋白质以改善肌肉质量和功能结果 (PROXIMUS)

基本信息

批准号：
10609050
负责人：
SAPNA R KUDCHADKAR
金额：
$ 34.46万
依托单位：
BOSTON CHILDREN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-04-15 至 2025-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10609050
关键词：
1 year old Acute Adherence Adverse effects Adverse event Age Bed rest Beds Caring Child Childhood Clinical Clinical Trials Cognitive Computers Country Coupled Creatinine Critical Illness Critically ill children Data Diet Disability Evaluation Disease Dose Enrollment Equilibrium Equipment and supply inventories Equipoise Exercise Goals Health Image Immobilization Impairment Incidence Injury to Kidney Intake Intervention Investigation Measurement Measures Mechanical ventilation Medical Metabolic Mission Morbidity - disease rate Muscle Muscular Atrophy National Institute of Diabetes and Digestive and Kidney Diseases Nutrient Nutritional Study Outcome Parenteral Nutrition Patient-Focused Outcomes Patients Pediatric Intensive Care Units Phase Physical Exercise Pilot Projects Population Proteins Protocol Compliance Protocols documentation Public Health Quality of life Randomized Randomized, Controlled Trials Rehabilitation therapy Reproducibility Research Priority Respiratory Failure Safety Serum Severity of illness Site Stereotyping Strategic Planning Survivors Testing Thick Time United States National Institutes of Health arm exercise regimen exercise rehabilitation experience functional outcomes functional status improved innovation lean body mass mortality muscle form nutrition open label pilot trial preservation programs psychologic quadriceps muscle randomized, clinical trials response safety and feasibility screening secondary analysis secondary outcome standard care trial comparing ultrasound

项目摘要

Mortality in U.S. pediatric intensive care units (PICUs) is improving, resulting in an increased focus on the quality of life of survivors who often have persistent physical, cognitive, and psychological impairments. Mechanically ventilated children in particular experience immobilization and poor nutrient intake, which results in muscle loss during acute illness. Early mobility and optimal nutrition during acute critical illness have been associated with muscle mass preservation and decreased duration of mechanical ventilation. These interventions may have the potential to decrease preventable PICU-acquired morbidities. However, the optimal doses and long-term benefits of these interventions have not been shown in randomized studies of critically ill PICU patients. Thus, we will test the first pediatric-specific, interprofessional intervention that integrates high protein and individualized exercise. This intervention was developed by a team of experts in the fields of nutrition, early mobility, rehabilitative exercise, muscle ultrasound (US), and functional outcomes. We propose a 2-center, pilot feasibility, randomized controlled trial (PROXIMUS) with the following Specific Aims: 1) To determine the feasibility and safety of a randomized open-label trial comparing high protein combined with individualized exercise vs. standard management during the acute phase of critical illness in children; 2) To determine the impact of high protein and individualized exercise on preservation of muscle mass; and 3) To determine the impact of high protein and individualized exercise on functional status at 1 month and 6 months after randomization. Outcomes: We will assess feasibility with a composite measure that combines predetermined thresholds for screening, enrollment, allocation, and compliance/adherence with significant separation in doses of protein and exercise between the two arms. Safety will be defined as absence of difference in rates of new renal injury and exercise-related adverse events. Preservation of muscle mass will be assessed by percent daily change in US-measured quadriceps femoris muscle thickness (QFMT) during the PICU stay. We will use a validated imaging protocol with high reliability and reproducibility. We will also examine the difference in the normative standard scores (T-scores) between the two arms for the Pediatric Evaluation of Disability Inventory – Computer Adaptive Test (PEDI-CAT) assessment. Other secondary outcomes are Functional Status Scale, PedsQL, and muscle quality by US. We hypothesize that a larger trial will be feasible and safe. Patients randomized to the combined intervention will have lower decline in QFMT and better scores on PEDI-CAT assessment. The PROXIMUS intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving long-term outcomes for the growing number of pediatric survivors of critical illness

美国儿科重症监护病房（PICUS）的死亡率正在改善，导致人们对生存质量的关注越来越大，这些生存质量通常具有持久的身体，认知和心理障碍。机械通风的儿童尤其经历了固定和营养不良的经历，从而导致急性疾病期间的肌肉损失。急性疾病期间的早期活动能力和最佳营养与肌肉质量保存和机械通气持续时间有关。这些干预措施可能有可能降低可预防的PICU获得的病因。但是，这些干预措施的最佳剂量和长期益处尚未在重症患者的随机研究中显示。这是我们将测试第一个小儿特异性的，跨性的干预措施，该干预措施整合了高蛋白质和个性化运动。这种干预是由营养，早期流动性，康复运动，肌肉超声（US）和功能性结果的专家团队开发的。我们提出了一个2中心的，试验可行性，随机对照试验（Proximus），其特定目的是：1）确定比较高蛋白与儿童急性疾病急性阶段的个性化运动与标准管理相结合的随机开放标签试验的可行性和安全性； 2）确定高蛋白和个性化运动对制备肌肉质量的影响； 3）确定高蛋白和个性化运动对随机分析后1个月和6个月功能状态的影响。结果：我们将通过一种复合度量来评估可行性，该综合度量结合了预定的阈值，用于筛查，入学，分配和依从性/依从性/依从性/依从性，并在两个臂之间进行显着分离蛋白质和运动。安全将定义为没有新的肾脏损伤率和与运动有关的不良事件的差异。在PICU停留期间，将通过每日变化的股股四头肌肌肉厚度（QFMT）来评估肌肉质量的保存。我们将使用具有高可靠性和可重复性的经过验证的成像协议。我们还将检查两个臂之间正常标准分数（T分数）的差异，以评估残疾库存 - 计算机自适应测试（PEDI-CAT）评估。其他次要结果是我们的功能状态量表，PEDSQL和我们的肌肉质量。我们假设更大的试验将是可行且安全的。随机进行干预措施的患者的QFMT下降量较低，并且在Pedi-CAT评估中得分更好。亲近干预措施有可能通过改善越来越多的危重疾病的小儿冲浪者的长期结局来深刻地改变PICU的医疗服务，并实质上影响了公共卫生