Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout- Protocol for an Exploratory Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- Region Skane
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight.
研究概览
简要总结
Young, healthy elite boxers ≥ 18 years old are recruited. Prior to, and immediately after a competitive boxing bout over 3x2 or 3x3 minutes, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation prior to baseline testing. After the initial post-fight blood sample is drawn and symptom rating using the sports concussion assessment tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 min, or routine post-fight management. The number of head impacts are counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial post-bout blood sample, as well as 3 and 6 days post-fight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female elite boxers ≥18 years old
- •Cleared for participation by the medical staff of the Swedish Boxing Association.
- •Informed consent by each participant prior to the competitive event
- •No boxing fights or match sparring during the initial 6 days after their last boxing fight
- •Signed informed consent.
排除标准
- •>40 years old or <18 years old
- •Participation in competitive fights, match-sparring or any training causing additional head impacts during the first six post-fight days after being included in the study.
- •History of autoimmune neurological diseases or a neurodegenerative disorder.
- •History of previous traumatic brain injury resulting in an intracranial haemorrhage.
研究组 & 干预措施
Boxers
干预措施: PolarCap System (Device)
Controls
结局指标
主要结局
Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight.
时间窗: 6 days
NFL (Neurofilament light), GFAP (Glial fibrillary acidic protein)
次要结局
- Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5).(6 days)