Mobile Subthreshold Exercise Program for Concussion (M-STEP)

年轻人的脑震荡越来越被认为是一个全国性的健康问题，影响到的人不止一个 每年有一百万名青年。高达30%的脑震荡青年经历了持续性和致残性 持续一个月以上的脑震荡症状，定义为持续性脑震荡后症状 (购买力平价)。PPC干扰社会关系，并对身体和学习功能产生不利影响。 之前治疗PPCS的建议侧重于认知和身体休息，但在2016年的指南中 这一转变是基于一项新的研究，表明了康复锻炼的好处。使用的背后的理由 运动是指逐渐增加体力活动的强度，以促进完全功能的恢复。 自那以后，康复运动已成为治疗患有PPCS的青少年最常见的方法之一。 然而，大多数项目需要每周与脑震荡专家进行集中访问，从而为 关心。为了弥补这一差距，我们开发了一种mHealth方法来治疗PPCS，利用体力活动跟踪器 (Fitbit)和每周与训练有素的研究人员举行的视频会议，以消除频繁的临床需求 来访。我们用这种方法进行了一系列试点研究，发现了极好的可行性、可接受性和 有证据表明，与对照组相比，脑震荡症状的下降更快。我们还发现了初步的 有证据表明，这种干预背后的机制可能源于两个生理过程，原因是 增加中等到剧烈的体力活动(MVPA)和心理过程，如减少恐惧- 避免脑震荡症状。因此，我们提出了一种完全有效的随机对照试验(RCT)来 严格审查《PPCS青少年活动阈值下锻炼计划》(M-STEP)。我们将招募 N=250名11-18岁的青年，持续1-6个月的PPCS，并将他们随机分为6周 常规护理加M-Step(干预)或常规护理加伸展(对照)。M-Step中的青年将接受指导 通过每周视频会议逐步增加康复锻炼的强度和持续时间 (Zoom)，并将使用Fitbit来指导他们的进展。伸展组中的年轻人将作为注意力控制， 有同等的学习联系人。所有青少年将使用活动记录仪完成MVPA的研究级测量 并在多个时间点进行标准化调查。青少年将接受为期6个月的跟踪调查。我们将使用 混合效应模型检验试验组之间在主要结果、轨迹上的差异 脑震荡症状和次要结果，随着时间的推移，与健康相关的生活质量的变化，对 意向治疗基础。建议的跨学科R01随机对照试验将提供明确的信息 关于M-STEP对患有PPCS的年轻人的疗效，检查包括MVPA在内的潜在介体 和恐惧回避，并探索生物心理社会因素(患者性别和父母)的影响 保护行为)。

Concussion in youth is increasingly being recognized as a national health concern, affecting more than one million youth each year. As many as 30% of youth with concussion experience persistent and disabling concussive symptoms lasting more than one month, defined as Persistent Post-Concussive Symptoms (PPCS). PPCS interferes with social relationships and adversely impacts physical and academic function. Previous recommendations for treating PPCS focused on cognitive and physical rest, but in 2016 guidelines shifted based on new research suggesting the benefit of rehabilitative exercise. The rationale behind the use of exercise is that gradual increases in the intensity of physical activity facilitates return to full function. Rehabilitative exercise has since become one of the most common approaches to treating youth with PPCS. However, most programs require weekly centralized visits with a concussion specialist, creating barriers to care. To bridge this gap, we developed an mHealth approach to treat PPCS, utilizing physical activity trackers (Fitbits) and weekly video conferences with trained research staff to eliminate the need for frequent clinical visits. We conducted a series of pilot studies with this approach, finding excellent feasibility, acceptability, and evidence for more rapid declines in concussive symptoms compared to controls. We also found preliminary evidence that mechanisms behind this intervention may stem from both physiologic processes due to increased moderate-to-vigorous physical activity (MVPA) and psychologic processes such as reducing fear- avoidance of concussive symptoms. We thus propose a fully powered, randomized controlled trial (RCT) to rigorously examine the “Mobile Subthreshold Exercise Program” (M-STEP) for youth with PPCS. We will recruit n=250 youth ages 11-18 years with PPCS lasting 1 to 6 months, and randomize them to 6 weeks of either usual care plus M-STEP (intervention) or usual care plus stretching (control). Youth in M-STEP will be coached through gradual increases in intensity and duration of rehabilitative exercise via weekly video conferencing (Zoom) and will use Fitbits to guide their progress. Youth in the stretching group will act as attention controls, with equivalent study contacts. All youth will complete research-grade measures of MVPA using actigraphy and standardized surveys at multiple time points. Youth will be followed for a total of 6 months. We will use mixed effects models to examine differences between experimental groups in the primary outcome, trajectory of concussive symptoms, and the secondary outcome, changes over time in health-related quality of life, on an intention-to-treat basis. The proposed transdisciplinary R01 RCT will provide definitive information regarding the efficacy of M-STEP for youth with PPCS, examine potential mediators including MVPA and fear-avoidance, and explore the impact of biopsychosocial factors (patient sex and parental protective behaviors).