Determination of the Physiological Profile and Evaluation of the Effect of Intense Physical Exertion Among Professional Athletes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluate the baseline level of salivary molecular biomarkers
研究概览
简要总结
Concussion (CC) (also called mild head trauma), which accounts for 85% of all head injuries, is very common in professional and amateur athletes. CC is an injury to the brain resulting from the direct or indirect impact of external mechanical forces, momentarily disrupting its function on a cellular level. Unlike more serious head injury (moderate and severe), which can be diagnosed using neuroimaging techniques (CT, MRI, etc.), patients suffering from CC do not necessarily show visible signs of structural abnormalities. As a result, diagnosis of CC is offen difficult.
Recently, several salivary biomarkers (proteins and nucleic acids) of sport related concussion have been identified in professional athletes. However, their reference values have not been determined with sufficient robustness to enable their employment in concussion diagnostic tests.
详细描述
Concussion (CC) (also called mild head trauma), which accounts for 85% of all head injuries, is very common in professional and amateur athletes. CC is an injury to the brain resulting from the direct or indirect impact of external mechanical forces, momentarily disrupting its function on a cellular level. Unlike more serious head injury (moderate and severe), which can be diagnosed using neuroimaging techniques (CT, MRI, etc.), patients suffering from CC do not necessarily show visible signs of structural abnormalities. As a result, diagnosis of CC is offen difficult. It is essentially based on subjective observational criteria and on the determination of the Glasgow Coma Scale (GCS) score, a score of 13 to 15 indicating potential CC. In approximately 15% of cases, symptoms such as momentary loss of consciousness (less than 30 minutes), amnesia lasting less than 24 hours, neurological deficit, or convulsions can be used to make a diagnosis. In the majority of cases, concussion goes undetected and no specific treatment or rehabilitation is put in place.
Recently, certain molecular biomarkers (BMs) of CC in elite athletes have been identified (Di Pietro et al. 2021; McCrea et al. 2020). However, the reference values of these BMs are not determined with sufficient robustness to enable the best use for concussion diagnostic tests.
To detect these biomarkers, it is first necessary to determine their physiological profiles as well as the changes in intensity associated with intense physical efforts during training session and/or matches.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants aged between 18 and 50 years old.
- •Participants willing to comply with the study procedures.
- •Participants capable of understanding the purpose, nature, and methodology of the study.
- •Participants affiliated to a French social security system or beneficiaries of such a system.
- •Participants who have signed the non-opposition form to participate in the research.
- •Non-inclusion Criteria:
- •Participant not affiliated to a French social security system or not a beneficiary of such a system.
- •Participants deprived of liberty, protected adults, vulnerable individuals, or minors.
- •Participants with a proven or suspected chronic infectious disease that may introduce a risk of contamination during sample handling (laboratories not equipped to handle this type of sample).
- •Refusal to sign the non-opposition form to participate in the research.
- •Non-inclusion specific criteria
- •Subject who has had a recent stroke or epilepsy event (within the past two months).
- •Subject suffering from neurological diseases.
排除标准
- 未提供
研究组 & 干预措施
Sub-group S-P
30 professional athletes whose weekly sport practice is more than 8 hours of contact sport.
干预措施: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion (Diagnostic Test)
Sub-group S-L
30 amateur athletes, having moderate physical activity whose weekly sport practice is between 4 and 8 hours of contact sport.
干预措施: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion (Diagnostic Test)
Sub-group S-O
20 control subjects who are occasional sport practitioners, having a low intensity physical activity with weekly practicing time is below 4h, excluding contacted sports.
干预措施: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion (Diagnostic Test)
结局指标
主要结局
Evaluate the baseline level of salivary molecular biomarkers
时间窗: 3 years
Quantification of salivary small non coding RNA (sncRNA) biomarkers of all study subjects: before, during and after intense or moderate sports practice (training and/or matches). Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change.
次要结局
- Differential analysis of expression signatures of salivary sncRNAs of the three groups(3 years)
- Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups(3 years)
- Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout different sport situations(3 years)
- Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout different sport situations(3 years)
- Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout the sports season(3 years)
- Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout the sports season(3 years)
研究者
Thi Nhu Ngoc VAN
Senior Researcher/Project Manager
Sys2Diag