Study of an Exercise Program (STEP) for Youth With Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Health Behavior Inventory (HBI)
研究概览
简要总结
To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth with persistent concussion symptoms.
详细描述
This is a minimal risk randomized controlled trial whose aim is to test the efficacy of an exercise intervention (STEP) for youth 11-18 yo with persistent concussive symptoms (1-6 months inclusive). The investigators are utilizing an active control (light stretching). The primary outcome will be concussion symptoms measured with the Health-Behavior Inventory (HBI) in the first month after randomization. Long-term efficacy will be examined using standardized measures of quality of life and function over 6 months, and potential mediators will be explored including brain derived neurotrophic factor (BDNF), fear-avoidance and physical fitness. Physical activity will be measured with accelerometry to evaluate fidelity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sports-related concussion that occurred 1-6 months inclusive prior to the start of the study, and was diagnosed by a clinician trained in concussion management consistent with the Zurich definition of concussion ("a complex pathophysiological process affecting the brain, induced by biomechanical forces [that] results in a graded set of clinical symptoms that may or may not involve loss of consciousness")
- •Persistent symptoms as defined by the presence of at least 2 concussive symptoms (from the Health Behavior Inventory, or HBI) at the time of recruitment which were not present prior to injury
- •11 to 18 years of age (inclusive) at time of recruitment
排除标准
- •Non-English speaking youth or parents
- •Unwilling or unable to travel to Seattle Children's Hospital or Seattle Children's Research Institute twice during the course of the study
- •Cervical spine or vestibular issues requiring further targeted intervention
- •Other injuries or medical conditions in addition to concussion which would preclude vigorous exercise
- •Psychiatric hospitalization in the year prior to enrollment
- •Significant cognitive deficits such as mental retardation or autism
- •Lack of worsening of concussive symptoms with exertion
- •Significant abnormalities on routine brain imaging.
研究组 & 干预措施
STEP-mhc + LS
Subjects will be asked to perform exercise at 80% of the heart rate threshold determined using the Balke protocol for 5 minutes greater than their measured minutes of MVPA/day at baseline (Subthreshold exercise program). They will also be given a light stretching protocol (5 stretches). The exercise intervention will last for 6 weeks and will be supported by weekly health coaching.
干预措施: Subthreshold exercise (STEP) with mobile health coaching (Behavioral)
STEP-mhc + LS
Subjects will be asked to perform exercise at 80% of the heart rate threshold determined using the Balke protocol for 5 minutes greater than their measured minutes of MVPA/day at baseline (Subthreshold exercise program). They will also be given a light stretching protocol (5 stretches). The exercise intervention will last for 6 weeks and will be supported by weekly health coaching.
干预措施: Light stretching (LS) (Behavioral)
LS alone
Subjects will be given a light stretching program alone (5 stretches). The exercise program will last for 6 weeks.
干预措施: Light stretching (LS) (Behavioral)
结局指标
主要结局
Health Behavior Inventory (HBI)
时间窗: Baseline, Weekly from 1-6 weeks, 3 months, 6 months
Measure change in concussion symptoms from the baseline evaluation to post-intervention (6 weeks) using HBI.
次要结局
- PedsQL(Baseline, 6 weeks, 3 and 6 months)
- Fear of Pain Questionniare (FOPQ), child and parent(Trajectory from baseline, 6 weeks, 3 months, 6 months)
- Moderate-vigorous physical activity (MVPA)(Baseline and 6 weeks)
研究者
Sara Chrisman
Assistant Professor
Seattle Children's Hospital