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临床试验/NCT06263179
NCT06263179已完成不适用

Feasibility of Aerobic Exercise for Recovery From Work-related Concussion

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2024年7月1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
11
试验地点
2
主要终点
Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed.

研究概览

简要总结

There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion.

详细描述

Participants who are diagnosed with a concussion and agree to participant in the study will complete a demographics form and other relevant questionnaires. They will then perform a graded exertion test (the Buffalo Concussion Treadmill Test [BCTT]) at the clinic, this takes approximately 15 minutes. Participants will then be prescribed the individualized THRAE based on the results from the BCTT and will be sent home with a commercial heart rate monitor. Participants will perform exercises at home on their free time 4-5 days per week. Participants will return to the clinic weekly to be re-examined by the study physician and obtain a new heart rate prescription for the first six weeks until clinical recovery or the intervention period ends (6-weeks).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-40
  • Received a concussion at work and are engaged with the workers compensation program
  • Within 3 weeks of concussive injury

排除标准

  • 3-point or less difference between current and pre-injury symptoms as measured by the Post-Concussion Symptom Inventory (PCSI)
  • Moderate or severe TBI
  • Injury involving loss of consciousness for >30 minutes or post-traumatic amnesia > 24 hours
  • Pre-existing conditions or presence of polytrauma that prevent participation in active testing and/or rehabilitation
  • History of more than 3 diagnosed concussions
  • Active substance abuse/dependence
  • Report of injury mechanism occurring due to physical assault
  • Unwillingness to perform intervention
  • Limited English proficiency.

结局指标

主要结局

Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed.

时间窗: Up to 6 weeks

Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting exercise sessions completed.

次要结局

  • Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5)(Baseline)
  • Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10)(Baseline, up to week 6)
  • Time to return to work measured in days(Up to week 6)
  • Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale(Baseline, week 1, week 2, week 3, week 4, week 5, week 6)
  • Change in Patient Health Questionnaire-9 (PHQ-9)(Baseline, up to week 6)
  • Work Climate Questionnaire - 6-Item Version(Baseline)
  • Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)(Baseline, up to week 6)
  • Change in Generalized Anxiety Disorder-7 (GAD-7)(Baseline, up to week 6)

研究者

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

Jacob I. McPherson

Clinical Assistant Professor

State University of New York at Buffalo

研究点 (2)

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