Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes

NCT06377306 | Recruiting

• 1 other identifier: MC study
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential "noise" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking. The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes. 200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC. Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment.

Conditions

Menstrual Cycle; Athletes; Physical Activity

Keywords

Menstrual cycle; Training load; Microbiome; Elite athletes

Outcome Measures

Primary Outcomes (9)

• Stool Microbiome

  Participants will receive kits in order to collect stool samples at home, and store it in their home freezers until they will be delivered to the Elinav lab at the Weizmann Institute, where they will be stored encoded at -80C. A whole-genome shotgun metagenomics sequencing will be performed on the samples. This will enable the investigators to sample all genes in all organisms present in each sample, including unknown unculturable bacteria.

  3-6 times during 12 months

• Serum metabolomics

  An untargeted high-performance liquid-chromatography mass-spectrometry is used to characterize the small molecules profile in plasma samplesץ

  3-6 times during 12 months

• VO2max

  Maximal Aerobic power

  3-6 times during 12 months

• Countermovement jump

  Countermovement jump performance will be measured using the Optojump Next system. The participants will be instructed to start from an upright position and to descend to a self-selected depth by bending at the hips and knees, immediately followed by a maximal vertical jump effort. Participants' hands will be kept on their hips throughout the entire movement. Participants will perform three attempts, separated by 30 seconds rest. Jump height will be recorded to the nearest 0.1 cm. The best and calculation of average jumps' height will be selected for statistical analysis.

  3-6 times during 12 months

• Flexibility

  Sit and reach and ankle dorsiflexion range of motion

  3-6 times during 12 months

• Grip Strength

  Maximal voluntary isometric hand grip

  3-6 times during 12 months

• Lower leg Strength

  Isokinetic strength during Knee extension and flexion

  3-6 times during 12 months

• Blood tests

  Blood tests will draw in the morning in a fasted state. The following parameters will be evaluated from the plasma: TSH (mlU/l), FT4 (pmol/l), FT3 (pmol/l), GH (ng/ml), IGF-1 (nmol/l), Testosterone total (nmol/l), Testo free (nmol/l), SHBG (nmol/l), Insulin (mU/l), 25OHD (nmol/l), Albumin (g/dl), Cortisol (nmol/l), Glucose (mg/dl)

  3-6 times during 12 months

• Knee valgus

  This test assesses dynamic knee valgus during a double leg drop jump using the reliable method of calculating the frontal plane projection angle. The athlete will perform a drop jump from a 30cm box landing with each foot on a force plate then immediately exploding upwards into a vertical jump. The athlete will be videoed using a video camera placed directly in front of the subject, 5m away. Markers will be placed by an experienced clinician on the midpoint of the femoral condyles, midpoint of the ankle malleoli, and proximal thigh along a line from the ASIS to the knee marker. The angle between line from the proximal thigh to the knee joint and line from the knee joint to the ankle at maximum knee flexion. Knee valgus = positive angle; Knee varus = negative angle. Reactive strength index will be calculated from force plate data providing information on plyometric performance, reactive jump capacity and dynamic explosive ability. The athlete will perform two drop jumps.

  3-6 times during 12 months

Secondary Outcomes (4)

• Anthropometric (Height)

  3-6 times during 12 months

• Psychological questionnaire (Positive-Affect Negative-Affect scale - PANAS)

  3-6 times during 12 months

• Anthropometric (Weight)

  3-6 times during 12 months

• Percentage body fat (%)

  3-6 times during 12 months

Other Outcomes (1)

• Psychological questionnaire (The Sport Emotion Questionnaire (SEQ)

  3-6 times during 12 months

Study Arms (2)

Regular cycle

Regular cycle length between 21-35 days.

Behavioral: Effect of training loads and sport performance level on health and sport performance

Irregular/contraceptives

Irregular cycles (under 21 days or more than 35 days). Contraceptives use of any type (Hormonal intervention).

Behavioral: Effect of training loads and sport performance level on health and sport performance

Interventions

Effect of training loads and sport performance level on health and sport performance BEHAVIORAL

Effect of training loads and sport performance level on health and sport performance

Irregular/contraceptives; Regular cycle

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Biologically female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Competitive elite and non-elite female athletes.

You may qualify if:

• Elite athletes are defined as participating and competing at national and/or international level at their sports.
• Non-elite athletes are defined as performing at least 3 hours of physical activity per week.

You may not qualify if:

• Currently pregnant or lactating or planning a pregnancy in the following year.
• Regular drug use which may affect performance, including but not limited to performance enhancing drugs.
• Any medical diagnosis, including recent or current injury, which could affect performance and/or health under the discretion of the study team.

Sponsors & Collaborators

• Wingate Institute: lead
• Weizmann Institute of Science: collaborator
• Kaplan Medical Center: collaborator
• Ministry of Innovation, Science and Technology of Israel: collaborator

Study Sites (1)

Wingate Institute

Netanya, Israel

RECRUITING

Related Publications (8)

• Sims ST, Heather AK. Myths and Methodologies: Reducing scientific design ambiguity in studies comparing sexes and/or menstrual cycle phases. Exp Physiol. 2018 Oct;103(10):1309-1317. doi: 10.1113/EP086797. Epub 2018 Aug 15.

  PMID: 30051938 BACKGROUND

• Pallavi LC, D Souza UJ, Shivaprakash G. Assessment of Musculoskeletal Strength and Levels of Fatigue during Different Phases of Menstrual Cycle in Young Adults. J Clin Diagn Res. 2017 Feb;11(2):CC11-CC13. doi: 10.7860/JCDR/2017/24316.9408. Epub 2017 Feb 1.

  PMID: 28384857 BACKGROUND

• Bahr R, Clarsen B, Derman W, Dvorak J, Emery CA, Finch CF, Hagglund M, Junge A, Kemp S, Khan KM, Marshall SW, Meeuwisse W, Mountjoy M, Orchard JW, Pluim B, Quarrie KL, Reider B, Schwellnus M, Soligard T, Stokes KA, Timpka T, Verhagen E, Bindra A, Budgett R, Engebretsen L, Erdener U, Chamari K. International Olympic Committee consensus statement: methods for recording and reporting of epidemiological data on injury and illness in sport 2020 (including STROBE Extension for Sport Injury and Illness Surveillance (STROBE-SIIS)). Br J Sports Med. 2020 Apr;54(7):372-389. doi: 10.1136/bjsports-2019-101969. Epub 2020 Feb 18.

  PMID: 32071062 BACKGROUND

• Nattiv A, Loucks AB, Manore MM, Sanborn CF, Sundgot-Borgen J, Warren MP; American College of Sports Medicine. American College of Sports Medicine position stand. The female athlete triad. Med Sci Sports Exerc. 2007 Oct;39(10):1867-82. doi: 10.1249/mss.0b013e318149f111.

  PMID: 17909417 BACKGROUND

• Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, O'Brien WL, Bassett DR Jr, Schmitz KH, Emplaincourt PO, Jacobs DR Jr, Leon AS. Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S498-504. doi: 10.1097/00005768-200009001-00009.

  PMID: 10993420 BACKGROUND

• Ashley CD, Kramer ML, Bishop P. Estrogen and substrate metabolism: a review of contradictory research. Sports Med. 2000 Apr;29(4):221-7. doi: 10.2165/00007256-200029040-00001.

  PMID: 10783898 BACKGROUND

• D'Eon TM, Sharoff C, Chipkin SR, Grow D, Ruby BC, Braun B. Regulation of exercise carbohydrate metabolism by estrogen and progesterone in women. Am J Physiol Endocrinol Metab. 2002 Nov;283(5):E1046-55. doi: 10.1152/ajpendo.00271.2002.

  PMID: 12376334 BACKGROUND

• Elliott-Sale KJ, Minahan CL, de Jonge XAKJ, Ackerman KE, Sipila S, Constantini NW, Lebrun CM, Hackney AC. Methodological Considerations for Studies in Sport and Exercise Science with Women as Participants: A Working Guide for Standards of Practice for Research on Women. Sports Med. 2021 May;51(5):843-861. doi: 10.1007/s40279-021-01435-8. Epub 2021 Mar 16.

  PMID: 33725341 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool and blood samples

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Rotem Kislev-Cohen, Ph.D

  Wingate Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yotam Shribman, B.Sc

CONTACT

+972-54-5723401; research@wingate.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: April 22, 2024
• Study Start: November 5, 2023
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)