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临床试验/NCT02714192
NCT02714192已完成不适用

Evaluation of the Safety of Exercise Testing With Acutely Concussed Adolescent Athletes

University at Buffalo2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Time to Full Recovery

研究概览

简要总结

The purpose of the study was to determine if administration of an exercise stress test within the first ten days after a sports related concussion would delay or otherwise interfere with recovery.

详细描述

The purpose of the study was to determine if administration of an exercise stress test within the first ten days after a sports related concussion would delay or otherwise interfere with recovery. All participants were adolescents injured while playing sports. All concussions were confirmed by an experienced sports medicine physician before random assignment of the participant to receive the treadmill test to determine exercise intolerance or not.

Recovery was defined as (a) return to asymptomatic state; (b) ability to exercise to exhaustion without exacerbation of symptoms and (c) confirmation of recovery by a physician who is blinded to the assignment and to results of exercise testing. Symptoms were self reported on a daily basis using an online data record.

Regardless of recovery rate all participants were assessed at two weeks following their first clinic visit. At the second visit all subjects, regardless of group assignment were assessed on ImPACT, and the treadmill based exercise stress test. Individuals who were not recovered by the second visit were followed until recovered no matter how long that took.

Analysis of data examined recovery rates of the two groups of adolescents to determine whether use of a exercise stress test early after concussion caused any adverse events or interfered in any way with recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents with sports related concussion that appear for their first clinic visit within 10 days of injury

排除标准

  • Evidence of focal neurologic deficit;
  • inability to exercise due to orthopaedic injury;
  • diabetes or known heart disease; increased cardiac risk; ADHD; depression; anxiety; history of moderate or severe brain injury; more than 3 prior concussions;
  • inability to understand spoken English.

结局指标

主要结局

Time to Full Recovery

时间窗: 2-168 days

Asymptomatic; Able to exercise to exhaustion without exacerbation of symptoms, confirmed by examination of a physician blinded to results

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barry Willer

Professor

University at Buffalo

研究点 (2)

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