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临床试验/NCT02432989
NCT02432989暂停不适用

Rest vs. Early Return to Exercise Following Concussion (H15-00307)

University of British Columbia2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
20
试验地点
2
主要终点
Change in EEG Functional Connectivity Using Graph Theoretical Modeling

研究概览

简要总结

This is a Phase 1 study to determine (1) the safety of an exercise protocol in adolescents and young adults with concussion in the first week post-injury and (2) to evaluate the effects of mild symptoms on brain function using EEG. This pilot study will inform subsequent grant applications, and a Phase II randomized control trial that will explore the influence of age on an early re-introduction to exercise, as well as the influence of varying intensity levels of exercise.

详细描述

The investigators will recruit a total of 20 patients between the ages of 15-25.Ten patients will be randomized to the "rest" group and ten to the "exercise" group.

All patients will then be invited to complete balance testing and a 5 minute resting state EEG at the Perception Action Lab at UBC's Djavad Mowafaghian Centre for Brain Health within 48 hours of their concussion. At this time all patients will be provided with an Actigraph GT3X+ from Actigraph Corp and requested to wear this on their wrist or ankle 24 hours a day, and record times in which the device is removed. The patients will wear this device until returning to UBC on day 7 post-injury. Daily questionnaires describing their physical and mental activity levels, and any concussion related symptoms they experienced will also be completed. This initial meeting will take approximately 90 minutes.

Afterwards, all patients will be invited to attend a standard post-concussion management visit with a physical therapist at FORTIUS Sport and Health in Burnaby BC, 48-72 hours after their injury. Both the rest and exercise groups will receive a "standard post-concussion management visit". In this visit, physical measures of c-spine range of motion (ROM), c-spine proprioception with laser (within 7 cm pass, >7 cm fail), strength, presence/absence of subjective symptoms, numeric c-spine rating scale, and neurocognitive testing will be completed. Those assigned to the exercise group will additionally complete 15 minutes of light-moderate aerobic exercise on a stationary bike. Activity levels will be determined by the physical therapist to individualize each program using heart rate reserve (HHR) and perceived exertion between 11-12 on the Visual Analogue Scale (VAS) for "Rating of Perceived Exertion". Patients will aim to achieve 65% of their HHR. The visit will take approximately 60 minutes, with an additional 20 minutes for those assigned to the exercise group.

On day 4 post-injury, all patients will continue with the standard care and recovery at home, completing their daily questionnaires of activity levels and post-concussion symptom reporting. Those assigned to the exercise group will be asked to complete 30 minutes of continuous leisurely walking at their convenience.

All patients will complete a second standard post-concussion management visit to FORTIUS Sport and Health on day 5 or 6 post-injury to repeat their standard concussion care and neurocognitive testing. Those in the exercise group will be invited to complete 30 minutes of light-moderate aerobic exercise (65% HHR) on the stationary bike following the aforementioned criteria. On the remaining day, all patients will continue with standard care and recovery at home; completing their daily questionnaires of activity levels and post-concussion symptom reporting. Those in the exercise group will again complete 30 minutes of continuous leisurely walking at their convenience while at home.

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
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Enrolled in participating minor sports association in the Greater Vancouver Area
  • •Sustained a recent sports related concussion (within 48 hours of contacting the research coordinators)

排除标准

  • •Less than 15 years of age or over 25 years old.
  • •Diagnosis of concurrent learning disability, ADHD, Autism or Seizure.

研究组 & 干预措施

Resting Control Group

No Intervention

Patients will receive standard concussion management, but will be asked not to exercise for the first 7 days after their concussion.

Exercise Group

Experimental

Patients will receive standard concussion management, but will be asked to exercise on a stationary bike on two different occasions (once for 15 minutes and again for 30 minutes) in their first week of recovery. This group will also be asked to complete a 30 minute leisurely walk at their convenience on the two days they are not tested at UBC or Fortius.

干预措施: Exercise (Behavioral)

结局指标

主要结局

Change in EEG Functional Connectivity Using Graph Theoretical Modeling

时间窗: Within 48 hours of concussion, and 7 days post-injury

Compare 5 minute resting state electroencephalogram (EEG) between rest and exercise groups. We will record the electrical activity (in Hertz) and compare values using Graph Theoretical measures that establish both global and local connectivity. We will look at the changes in composite measures of betweenness, global efficiency, clustering coefficient, and hub value.

次要结局

  • Change in Subjective Symptom Reporting(Days 1,2,3,4,5,6 through 7 inclusive post-injury)
  • Differences in Activity Levels(Days 1,2,3,4,5,6 through 7 inclusive post-injury)

研究者

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

Naznin Virji-Babul

Dr. Naznin Virji-Babul

University of British Columbia

研究点 (2)

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