Healthy Volunteer
Conditions
Keywords
ultra endurance
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEchocardiography
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.
PROCEDUREArterial 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.
BIOLOGICALBlood 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.
BEHAVIORALScales 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.
PROCEDUREVital 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.
BIOLOGICALUrinary test
Pregnancy test will be performed before the race.
Sponsors
French Cardiology Society
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac function | 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 | Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race. | Inflammatory profile adjusted for baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hormonal parameters | Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race. | Hormonal profile adjusted for baseline |
| Vascular adaptations | Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race. | Carotid artery and femoral artery diameter adjusted for baseline |
| Defense mechanisms regarding emotional dynamics | Before the race, at the 3 refreshment stations, at the arrival of the race. | Defense Style Questionnaire-26 questionnaire is a standardized questionnaire developed to assess defense mechanisms: adaptive (humor, anticipation, self-assertion, altruism, self-observation) and maladaptive defenses (help rejecting complaining, splitting other, projection, dissociation, intellectualization, devaluation/self, fantasy, devaluation of other). These items are rated on a Likert scale from 1 to 6 points; 1 corresponding to "strongly disagree" and 6 to "strongly agree". |
Countries
France
Contacts
CONTACTTessa BERGOT, MSc
PRINCIPAL_INVESTIGATORRomain JOUFFROY, MD
CHU d'Orléans
Outcome results
None listed