Healthy
Conditions
Keywords
female elite athlete, menstrual phase, amenorrhea, hormonal contraception, performance, health, Athlete Biological Passport
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)
Interventions
OTHERMultidisciplinary monitoring of healthy women
Multidisciplinary monitoring
Sponsors
Université Paris-Saclay-Assistance publique des hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
2 groups : female athletes and leisure sports women
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline inflammatory parameters | 6 months | concentration of cytokines (TNF-alpha, IL-6) 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 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 respiratory parameters | 6 months | measure of FEV1 (forced expiratory volume in 1 second), expressed in % of vital capacity |
| 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 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 |
Contacts
Primary ContactEmmanuelle DURON, PU-PH
Backup ContactChristine Le-Scanff, PU
Outcome results
None listed