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

ConditionHealthy Volunteer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFrench Cardiology Society

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Must have a Global Positioning System watch during the race;

"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;

Medical certificate stating no contraindications to competitive running, dated less than 12 months prior to the race;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Echocardiography

    Procedure/Surgery

    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.

  • Arterial ultrasound

    Procedure/Surgery

    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/Vaccine

    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/Surgery

    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/Vaccine

    Pregnancy test will be performed before the race.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Intervention groupExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Cardiac function

Echocardiographic measurements of left ventricular ejection fraction as a percentage

Time frame
Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
2

Systemic inflammatory parameters

Inflammatory profile adjusted for baseline

Time frame
Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.

Secondary outcomes

1

Hormonal parameters

Hormonal profile adjusted for baseline

Time frame
Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
2

Vascular adaptations

Carotid artery and femoral artery diameter adjusted for baseline

Time frame
Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
3

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".

Time frame
Before the race, at the 3 refreshment stations, at the arrival of the race.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

French Cardiology Society

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: