Hormonal Status, Performance and Health in Elite Female Athlete
- Conditions
- Healthy
- Interventions
- Other: Multidisciplinary monitoring of healthy women
- Registration Number
- NCT05028959
- Lead Sponsor
- Université Paris-Saclay-Assistance publique des hôpitaux de Paris
- Brief Summary
The repercussions of the hormonal status of high-level sportswomen on their performance and health as well as on the Athlete's Biological Passport (ABP) have been little studied and remain poorly known. The investigators therefore propose to contribute to the improvement of current knowledge by determining, thanks to the implementation of a multidisciplinary monitoring, with the use of various tests and matrices, in female elite athletes and recreational athletes (control group):
* 1) the impact of cycle phase, absence of cycle or contraceptive use on physical and psychological performance, health as well as on ABP;
* 2) the potential confounding effects of the athlete's environment
* 3) correlations between the different matrices analyzed
- Detailed Description
Volunteers to be studied: 80 healthy female subjects (16 to 30 years old), divided into 2 groups:
Group 1: 60 athletes, from different sports disciplines, in amenorrhea, with menstrual cycle or taking contraceptives
Group 2: 20 leisure sports subjects with menstrual cycle or taking contraceptives
Following the oral and written information of the project, the subjects have a minimum of 15 days of reflection before signing the written consent form. They will have the possibility, at any time, to voluntarily interrupt the study without having to justify themselves.
Investigations to be performed:
1. Annual complete clinical examination :
2. "Out-of-competition" follow-up, time frame 6 months
* medical, nutritional and respiratory monitoring
* biological monitoring
* psychological monitoring
* performance monitoring
3. Non-invasive "in-competition" monitoring, only for Group 1, once in a year on the day before/after a major competition:
* biological monitoring
* psychological monitoring
* performance monitoring (interview)
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- Group 1: high-level athletes (qualified for national/international championships and/or training at least 15 hours/week)
- Group 2: recreational athletes who practice a regular physical activity
- Participation in another trial
- History of cardiac pathology
- High blood pressure
- History of ulcers and other gastrointestinal disorders
- Myasthenia
- Renal insufficiency
- Person not affiliated or not benefiting from a social security system
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Leisure sport women Multidisciplinary monitoring of healthy women recreational sportswomen practicing regular physical activity Female athletes Multidisciplinary monitoring of healthy women highly trained subjects
- Primary Outcome Measures
Name Time Method Change from baseline metabolic parameters 6 months concentration of blood glucose, blood lactate, lipid profile, insulin, GH, IGF1, T3, IgA, PRL and leptin in mol/L
Change from baseline weight 6 months in kg, by impedancemeter
Change from baseline fat and lean mass 6 months in kg, by impedancemeter
Change from baseline height 6 months in cm, by height gauge
Change from baseline sex and stress hormones 6 months concentration of oestradiol, progesterone, testosterone, DHEA, cortisol, LH and FSH in mol/L
Change from baseline food intake 6 months food intake questionnaire to complete over 3 days, expressed in kcal/day
Change from baseline inflammatory parameters 6 months concentration of cytokines (TNF-alpha, IL-6) in mol/L
Change from baseline executive function 6 months assessed by instability via static and dynamic postures (eyes open/closed) on platform
Change from baseline visual-spatial processing 6 months 3 D mental rotation test, assessed by scores: range from 0 - 24, with 24 representing a perfect total score
Change from baseline attention and working memory 6 months Stroop Color Word Task, assessed by scores : range of interference from -15 - +15, with higher scores representing decreased selective attention
Change from baseline performance monitoring 6 months field performance test, performance expressed in time
Change from baseline Athlete Biological Passport (Group 2) 6 months assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
Change from baseline respiratory parameters 6 months measure of FEV1 (forced expiratory volume in 1 second), expressed in % of vital capacity
Change from baseline affects (Group 2) 6 months Positive Affect and Negative Affect Schedule (PANAS), assessed by scores. Positive Affect Score: range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: range from 10 - 50, with lower scores representing lower levels of negative affect.
Change from baseline anxiety (Group 2) 6 months Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
Change from baseline Athlete Biological Passport (Group 1) 8 months assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
Change from baseline affects (Group 1) 8 months Positive Affect and Negative Affect Schedule (PANAS), assessed by scores. Positive Affect Score: range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: range from 10 - 50, with lower scores representing lower levels of negative affect.
Change from baseline anxiety (Group 1) 8 months Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
Interview (Group 1) 8 months Self-confrontation interview for questioning the action
- Secondary Outcome Measures
Name Time Method