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Clinical Trials/NCT05576740
NCT05576740
Completed
Not Applicable

Influence of Menstrual Cycle Stages on Physical Fitness in Female Athletes

Universitat Jaume I1 site in 1 country41 target enrollmentMarch 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Menstrual Cycle
Sponsor
Universitat Jaume I
Enrollment
41
Locations
1
Primary Endpoint
Change in 17β-oestradiol concentration (in pg/mL)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The influence of the menstrual cycle on women's sports performance is still uncertain. Research on this topic shows methodological biases. The aim of the study will be to determine whether the menstrual cycle affects women's physical fitness, measuring this in 3 differentiated stages of the cycle: the early follicular phase, late follicular phase, and luteal phase. For this purpose, a blood test will be carried out in each phase, with hormone determination (oestradiol and progesterone) and a haemogram to determine the existence of possible anemia. After the extraction and other complementary tests (measurement of vital signs, bioimpedance...) the woman will undergo 3 physical tests to compare the results in the 3 phases. A group of women taking hormonal contraception will also be included, performing the same interventions. To determine whether the woman is ovulating or not, urinary luteinizing hormone (LH) strips will be given to the women and they will have to take them from day 8 of the cycle. In addition, women will wear an accelerometer to monitor their daily activity and to be able to observe if there is an influence on this stage of the menstrual cycle.

Registry
clinicaltrials.gov
Start Date
March 16, 2022
End Date
July 15, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Universitat Jaume I
Responsible Party
Principal Investigator
Principal Investigator

Paula Recacha Ponce

Investigador principal

Universitat Jaume I

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria natural cycles group:
  • Female sex
  • Women between 18 and 40 years of age
  • Women who are members of a federation and who compete in a sport doing at least 240 minutes of exercise per week.
  • Women with regular menstrual cycles (between 23 and 38 days long).
  • Women who have not taken hormonal contraceptives (HA) for 6 months or more.
  • Inclusion criteria artificial cycles group:
  • Female sex
  • Women between 18-40 years of age
  • Women federated and competed in a sport doing at least 240 minutes of exercise per week.

Exclusion Criteria

  • Exclusion criteria group natural cycles:
  • Refusal to participate in the study
  • Sedentary women
  • Women on HA currently or in the 6 months before the study
  • Women with irregular menstrual cycles, less than 23 or more than 38 days in length
  • Any existing metabolic disease or disorder
  • Regular use of medications or dietary supplements that could affect the results
  • Pregnancy or breastfeeding
  • Exclusion criteria artificial cycles group:
  • Refusal to participate in the study

Outcomes

Primary Outcomes

Change in 17β-oestradiol concentration (in pg/mL)

Time Frame: three times in a month

concentration of 17β-oestradiol in pg/mL

Change from baseline grip strength

Time Frame: three times in a month

measuring of changes in muscle strength by handgrip dynamometer in the hand to be tested (handgrip test). Three attempts on each hand.

Change from baseline indirect maximum oxygen consumption

Time Frame: three times in a month

by the Course Navette test

Change in cortisol concentration (in μg/dL)

Time Frame: three times in a month

concentration of cortisol in μg/dL

Change in TSH concentration (in mcUI/mL)

Time Frame: three times in a month

concentration of thyroid-stimulating hormone (TSH) and basal insulin in mcUI/mL

Change in SHBG concentration (in nmol/L)

Time Frame: three times in a month

concentration of sex hormone binding globulin (SHBG) in nmol/L

Change in LH and FSH concentration (in mUI/mL)

Time Frame: three times in a month

Concentration of luteinizing hormone (LH) and FSH (follicle stimulating hormone) in mUI/mL

Change from baseline sensory and pain threshold

Time Frame: three times in a month

by electrical muscle stimulator (Digitimer DS7A)

Change in progesterone concentration (in ng/mL)

Time Frame: three times in a month

Concentration of progesterone, prolactin and total testosterone in ng/mL

Change in T3 concentration (in ng/dL)

Time Frame: three times in a month

concentration of T3 in ng/dL

Change from baseline physical and mental symptoms associated with the menstrual cycle by The Daily Record of Severity of Problems questionnaire

Time Frame: Duration of a full menstrual cycle (approximately 28 days)

By The Daily Record of Severity of Problems (DRSP) questionnaire. This scale measures symptoms subjectively from 1 to 6, where 1 corresponds to "not at all" and 6 corresponds to "extreme". The higher the score, the more severe the symptom is.

Change in T4 concentration (in mcg/dL)

Time Frame: three times in a month

concentration of T4 in mcg/dL

Change in free testosterone concentration (in pmol/L)

Time Frame: three times in a month

Concentration of free testosterone in pmol/L

Change from baseline jumping height

Time Frame: three times in a month

Measuring of change in muscle power through Squat jump without additional weight, Squat jump with 50% of body weight, Countermovement jump, Abalakov jump, and Drop jump by Chronojump contact mat, in cm. Three tries on each jump.

Change from baseline flexibility

Time Frame: three times in a month

measurement of changes in the range of motion of the hamstring musculature, by sit and reach test (cm). Three tries.

Change from baseline daily activity

Time Frame: Duration of a full menstrual cycle (approximately 28 days)

by accelerometer (GENEActiv): Wrist-worn device measuring accelerations as a measure of daily activity, in cpm, counts per minute.

Secondary Outcomes

  • Change in ferritin concentration (in ng/mL)(three times in a month)
  • Change in hemoglobin concentration (in g/dL)(three times in a month)
  • Change in Basal metabolic rate in kcal(three times in a month)
  • Change in iron concentration (in μg/dL)(three times in a month)
  • Change in total body water in liters (L)(three times in a month)
  • Change in Blood pressure in mmHg(three times in a month)
  • Change in transferrin concentration (in mg/dL)(three times in a month)
  • Change in white blood cells and platelets concentration (in 10^3/μl)(three times in a month)
  • Change in weight, proteins, minerals and body fat mass in kg(three times in a month)
  • Change in heart rate in bpm(three times in a month)
  • Change in hematocrit concentration (in %)(three times in a month)
  • Change in red blood cells concentration (in 10^6/μl)(three times in a month)
  • Change in Body Mass Index (BMI) in kg/m2(three times in a month)

Study Sites (1)

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