Women's Heart: Impact of Ultra-endurance and Hormonal Profile on Cardiac and Systemic Inflammatory Parameters in Female Runners

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Echocardiography
  6 transthoracic echocardiography will be performed: 1 before the race, 3 during the race (refreshment station), 1 at the end of the race, 1 at the follow up visit 9 days after the race. It is not possible to specify the intervention time, as this depends on the participants' running pace.
• Процедура Arterial ultrasound
  6 ultrasound of the carotid and femoral arteries will be performed: 1 before the race, 3 during the race (refreshment station), 1 at the end of the race, 1 at the follow up visit 9 days after the race. It is not possible to specify the intervention time, as this depends on the participants' running pace.
• Биопрепарат Blood sampling
  6 blood sampling (2 milliliters) will be performed: 1 before the race, 3 during the race (refreshment station), 1 at the end of the race, 1 at the follow up visit 9 days after the race. It is not possible to specify the intervention time, as this depends on the participants' running pace.
• Поведенческое Scales and questionnaire
  Before the race, during the race (refreshment station), and at the end of the race participant will be asked to complete the study questionnaire and scales. It is not possible to specify the intervention time, as this depends on the participants' running pace.
• Процедура Vital signs
  6 measurements of blood pressure, heart rate, respiratory rate, pulse oxygen saturation, and muscle oxygen saturation will then be taken: 1 before the race, 3 during the race (refreshment station), 1 at the end of the race, 1 at the follow up visit 9 days after the race. It is not possible to specify the intervention time, as this depends on the participants' running pace.
• Биопрепарат Urinary test
  Pregnancy test will be performed before the race.

Первичные конечные точки

• Cardiac function [Срок оценки: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.]
• Systemic inflammatory parameters [Срок оценки: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.]

Вторичные конечные точки (3)

• Hormonal parameters [Срок оценки: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.]
• Vascular adaptations [Срок оценки: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.]
• Defense mechanisms regarding emotional dynamics [Срок оценки: Before the race, at the 3 refreshment stations, at the arrival of the race.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Hôpital Henri Mondor, APHP — Créteil

Идентификаторы

NCT: NCT07372859 · 2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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