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临床试验/NCT06147596
NCT06147596已完成不适用

Heading in Football: Impact on Neural Blood Biomarkers

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 335 人开始时间: 2024年8月13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
335
试验地点
1
主要终点
Concentration of serum neurofilament light protein

研究概览

简要总结

The goal of this observational study is to evaluate the safety of heading in football. We will study the release of biomarkers in blood that reflect microscopic neural damage. The main questions this study aims to answer are:

  • Does participation in a football match lead to a change in biomarkers that reflect microscopic neural damage?
  • Is the dose of exposure during a football match related to the magnitude of change in biomarkers that reflect microscopic neural damage?

Participants will participate in a regular football match and provide blood samples before and right after the football match. The football match will be recorded on video to count the number of headers of all participants.

详细描述

The objective of this prospective observational study is to determine the potential impact of ball heading in football on brain integrity as assessed by blood biomarkers for neural damage in a real-world setting. Healthy amateur football players will be recruited to participate in the study. Participants will be invited to play a regular football match for investigation purposes. They will provide a blood sample within one hour before the start of the match and a second blood sample within one hour after the match. Participants will be asked to provide a third blood sample within 48 hours after participation, but this is not obligatory. The football match will be recorded on video to determine the number of head impacts of all participants. Furthermore, participants will wear heart rate sensors and local positioning sensors to determine the internal and external training load and account for the possible confounding effects of exercise on neural blood biomarkers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Member of the KNVB;
  • 18 years or older;
  • Self-reported fitness to play 70-90 minutes (absence of injury).

排除标准

  • Sustained a head injury in the last year;
  • History or current neurological condition;
  • Regular participation in other contact sports (e.g. rugby, American football, ice hockey, fighting sports);
  • (Former) military personnel with a history of fighting/blast exposure

结局指标

主要结局

Concentration of serum neurofilament light protein

时间窗: T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match)

The difference in serum neurofilament light protein between pre-match samples and post-match samples.

次要结局

  • Concentration of serum p-tau protein(T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match))
  • Concentration of serum Glial Fibrillary Acidic Protein(T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match))
  • Concentration of serum beta-synuclein(T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match))
  • Concentration of serum Neuron Specific Enolase protein(T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match))
  • Concentration of serum S100B protein(T0 (<1hour pre-match), T1 (<1hour post-match), T2 (<48hour post-match))

研究者

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

Prof. dr. Jaap Oosterlaan

Director Follow me programme

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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