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临床试验/NCT02959216
NCT02959216已完成不适用

Sub-Symptom Aerobic Exercise Therapy to Improve Recovery From Acute Sport-Related Concussion: A Randomized Controlled Trial

Children's Hospital of Philadelphia6 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2018年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
6
主要终点
Time to recovery

研究概览

简要总结

The use of aerobic exercise treatment in the chronic phase of concussion recovery is well-described in the literature but there are limited existing data on the effect of exercise treatment in the acute phase after sport-related concussion (SRC). This study will compare the outcomes of adolescents with a recent SRC who are randomized to sub-threshold aerobic exercise versus those randomized to placebo stretching to evaluate the effect of aerobic exercise in the acute recovery phase.

详细描述

Historically, concussion has been described as a cognitive injury and patients have been advised not to engage in any cognitive or physical exertion while symptomatic. More recently, however, concussion has been described as a physiological injury affecting both the heart and autonomic nervous system, and patients suffering from prolonged concussion-related symptoms and deficits have been encouraged to begin aerobic exercise as part of their concussion care. While intensive exercise too soon after concussion has been associated with delayed recovery and used to justify prolonged periods of rest, recent studies have shown that controlled, sub-symptom threshold aerobic exercise may aid recovery by improving autonomic balance and cerebral blood flow auto-regulation after concussion. This study will randomly assign pediatric patients with concussion to a treatment group in which they will complete sub-symptom threshold aerobic exercise or to a placebo group in which they will complete a standardized stretching protocol. All participants will have routine visits that consist of a physical examination and exercise test until the intervention ends at recovery or 1-month post-randomization.

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
Double (Care Provider, Investigator)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Time to recovery

时间窗: 3 to 28 days

Recovery is defined as symptom resolution, exercise tolerance, and normal clinical examination.

次要结局

  • Persistence of post-concussive symptoms(29 to 112 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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