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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac function | Echocardiographic measurements of left ventricular ejection fraction as a percentage | Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race. |
| Systemic inflammatory parameters | Inflammatory profile adjusted for baseline | Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race. |
| Measure | Description | Time Frame |
|---|---|---|
| Hormonal parameters | Hormonal profile adjusted for baseline | Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race. |
| Vascular adaptations | Carotid artery and femoral artery diameter adjusted for baseline |
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Inclusion Criteria:
Must have a Global Positioning System watch during the race;
Must participate in one of the following races:
Must comply with the race regulations:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tessa BERGOT, MSc | Contact | +33144907033 | tessa.bergot@sfcariod.fr |
| Name | Affiliation | Role |
|---|---|---|
| Romain JOUFFROY, MD | CHU d'Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor, APHP | Créteil | France |
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|
| Arterial ultrasound | Procedure | 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. |
|
| Blood sampling | Biological | 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. |
|
| Scales and questionnaire | Behavioral | 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. |
|
| Vital signs | Procedure | 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. |
|
| Urinary test | Biological | Pregnancy test will be performed before the race. |
|
| Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race. |
| Defense mechanisms regarding emotional dynamics | 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". | Before the race, at the 3 refreshment stations, at the arrival of the race. |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D014894 | Weights and Measures |
| D011795 | Surveys and Questionnaires |
| D000919 | Antibody-Coated Bacteria Test, Urinary |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D005455 | Fluorescent Antibody Technique |
| D007150 | Immunohistochemistry |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D006652 | Histological Techniques |
| D007159 | Immunologic Tests |
| D003950 | Diagnostic Techniques, Urological |
| D007158 | Immunologic Techniques |
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