Women's Heart: Impact of Ultra-endurance and Hormonal Profile on Cardiac and Systemic Inflammatory Parameters in Female Runners
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cardiac function
研究概览
简要总结
The goal of this clinical trial is to describe the cardiac and systemic inflammatory adaptations specific to women practicing ultra-endurance sports.
The objectives are to:
- Improve the understanding of cardiac and systemic inflammatory adaptations specific to women participating in ultra-endurance sports.
- Assess the relationship between observed cardiac and systemic inflammatory alterations and the relative levels of estrogen, testosterone, and progesterone.
- Describe the vascular adaptations specific to women participating in ultra-endurance sports.
- Examine the influence of defense mechanisms on the emotional dynamics observed during and after an ultra-endurance race.
详细描述
This is a French national non-comparative descriptive study. The study is conducted on healthy volunteers. 80 to 100 patients will be included, half of the inclusions on the "Ecotrail de Paris Ile France©"( = a trail running race in the Paris region. It is not possible to translate; it is a registered trademark) the second half of the inclusions on the "6000D©" in Savoie.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must have a Global Positioning System watch during the race;
- •Must participate in one of the following races:
- •"Ecotrail de Paris Ile France©" (=a trail running race in the Paris region, it is not possible to translate; it is a registered trademark) 80 kilometers;
- •Or "la 6000D©" 69 kilometers;
- •Must comply with the race regulations:
- •Medical certificate stating no contraindications to competitive running, dated less than 12 months prior to the race;
- •Or a valid sports license on the day of the race.
- •Must agree to participate in the study, sign the consent form, and allow the sponsor to use their data for the purposes of this study.
排除标准
- •Refusal or linguistic or mental incapacity to sign the informed consent form;
- •Person under guardianship (conservatorship, curators, or legal protection) or deprived of liberty;
- •Person not affiliated with a social security scheme;
- •Pregnant woman;
- •Person participating in a drug study;
- •Women with a medical history (chronic lung disease, heart disease, pharmacologically treated hypertension) or with a known significant chronic inflammatory disease at the time of the enrollment visit;
- •Person who has already participated in this study in a previous race.
研究组 & 干预措施
Intervention group
Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race.
干预措施: Echocardiography (Procedure)
Intervention group
Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race.
干预措施: Arterial ultrasound (Procedure)
Intervention group
Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race.
干预措施: Blood sampling (Biological)
Intervention group
Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race.
干预措施: Scales and questionnaire (Behavioral)
Intervention group
Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race.
干预措施: Vital signs (Procedure)
Intervention group
Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race.
干预措施: Urinary test (Biological)
结局指标
主要结局
Cardiac function
时间窗: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
Echocardiographic measurements of left ventricular ejection fraction as a percentage
Systemic inflammatory parameters
时间窗: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
Inflammatory profile adjusted for baseline
次要结局
- Hormonal parameters(Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.)
- Vascular adaptations(Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.)
- Defense mechanisms regarding emotional dynamics(Before the race, at the 3 refreshment stations, at the arrival of the race.)