The Impact of the Menstrual Cycle on Physical Exercise and Performance

NCT05697263 | Recruiting

• 1 other identifier: 2021-01650
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The menstrual cycle implies a basic difference in the biology of women and men but the effect of the hormonal variation on training protocols and physical performance is still not fully understood. Despite no existing evidence, the advice to periodize exercise according to the menstrual cycle has been widely spread among elite athletes, coaches, and sports federations. The advice is based on underpowered studies with considerable methodological weaknesses regarding determination of cycle phase, inclusion of athletes and lack of adequate control groups. The purpose of this randomized, controlled study is to evaluate the effect of exercise periodization on aerobic fitness during different phases of the menstrual cycle. Further, the effect will be related to premenstrual symptoms, body composition and skeletal muscle morphology, sex hormone receptors, metabolic enzymes, and markers of muscle protein synthesis. This study will be well controlled and follow methodology recommendations for menstrual cycle research in sports and exercise. Female athletes of fertile age will be randomized to different training regimens during three menstrual cycles (12 weeks): Group A: Training three times a week throughout the menstrual cycle. Group B: Follicular phase-based training five times a week during the follicular phase and thereafter once a week during the luteal phase. Group C: Luteal phase-based training five times a week during the luteal phase and once a week in the follicular phase. The exercise will consist of high intensity intermittent spinning classes. Assessment of aerobic fitness and power will be performed at baseline, and again after three completed menstrual cycles. On the same day, body composition will be examined by DXA and blood samples will be collected for analysis of hormones and binding proteins. To confirm menstrual cycle phase, blood samples will be collected for hormone determination, and urinary stick will be used for detection of ovulation. Subjective ratings of menstrual cycle related symptoms will be performed every day. In a subgroup of women, muscle biopsies will be collected from m vastus lateralis at baseline and at the end of the study. This study will contribute to improved knowledge about exercise periodization in relation to the menstrual cycle. Well-grounded data is crucial to give evidence-based recommendations to female athletes when planning their training protocol to optimize training results and performance.

Conditions

Menstrual Cycle; Exercise; Women's Health; Athletic Performance

Keywords

Menstrual Cycle; Exercise; Women's Health; Athletic Performance

Outcome Measures

Primary Outcomes (1)

• Change in aerobic performance

  Cosmeds K5 Wearable Metabolic System will be used for breath-by-breath gas exchange measurements. Change in VO2peak from baseline to end of study will be evaluated.

  Change from baseline aerobic performance at the end of Cycle 4 (each cycle is around 28 days)

Secondary Outcomes (11)

• Change in muscle strength

  Change from baseline muscle strength at the end of Cycle 4 (each cycle is around 28 days)

• Change in one-leg sit-to-stand test

  Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)

• Change in one-leg hop test for distance

  Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)

• Change in body composition

  Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)

• Change in body composition

  Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)

Other Outcomes (1)

• Confirmation of menstrual cycle phase

  Through study completion, an average of 4 months

Study Arms (3)

Follicle phase based training

EXPERIMENTAL

Follicular phase-based training five times a week during the follicular phase (the first two weeks of the menstrual cycle) and thereafter once a week for the rest of the cycle.

Other: Periodization of training

Luteal phase based training

EXPERIMENTAL

Luteal phase-based training five times a week during the luteal phase (from ovulation to next menstruation) and once a week in the follicular phase.

Other: Periodization of training

Regular training

EXPERIMENTAL

Regular training three times a week throughout the menstrual cycle (control group).

Other: Periodization of training

Interventions

Periodization of training OTHER

Participants in the three arms will exercise the same dose and number of sessions distributed in three different ways.

Follicle phase based training; Luteal phase based training; Regular training

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women exercising at least 3-4 times a week on a high level
• Regular menstrual cycle with 26-32 cycle days.
• Fully healthy and be able to follow the training program.

You may not qualify if:

• Hormonal contraceptive users,
• Users of regular medication
• Chronic disease
• Past or present neurological disorder
• Recent musculoskeletal injury

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Angelica Lindén Hirschberg

Stockholm, 17176, Sweden

RECRUITING

Related Publications (14)

• von Rosen P, Ekenros L, Solli GS, Sandbakk O, Holmberg HC, Hirschberg AL, Friden C. Offered Support and Knowledge about the Menstrual Cycle in the Athletic Community: A Cross-Sectional Study of 1086 Female Athletes. Int J Environ Res Public Health. 2022 Sep 21;19(19):11932. doi: 10.3390/ijerph191911932.

  PMID: 36231231 BACKGROUND

• Ekenros L, von Rosen P, Solli GS, Sandbakk O, Holmberg HC, Hirschberg AL, Friden C. Perceived impact of the menstrual cycle and hormonal contraceptives on physical exercise and performance in 1,086 athletes from 57 sports. Front Physiol. 2022 Aug 30;13:954760. doi: 10.3389/fphys.2022.954760. eCollection 2022.

  PMID: 36111164 BACKGROUND

• Ekenros L, Backstrom T, Hirschberg AL, Friden C. Changes in premenstrual symptoms in women starting or discontinuing use of oral contraceptives. Gynecol Endocrinol. 2019 May;35(5):422-426. doi: 10.1080/09513590.2018.1534097. Epub 2019 Jan 22.

  PMID: 30668208 BACKGROUND

• Von Rosen P, Kottorp A, Friden C, Frohm A, Heijne A. Young, talented and injured: Injury perceptions, experiences and consequences in adolescent elite athletes. Eur J Sport Sci. 2018 Jun;18(5):731-740. doi: 10.1080/17461391.2018.1440009. Epub 2018 Mar 3.

  PMID: 29504456 BACKGROUND

• von Rosen P, Heijne A, Frohm A, Friden C. Menstrual irregularity and use of oral contraceptives in female adolescent athletes in Swedish National Sports High Schools. Int J Adolesc Med Health. 2017 Nov 23;32(2):/j/ijamh.2020.32.issue-2/ijamh-2017-0113/ijamh-2017-0113.xml. doi: 10.1515/ijamh-2017-0113.

  PMID: 29168967 BACKGROUND

• Ekenros L, Papoutsi Z, Friden C, Dahlman Wright K, Linden Hirschberg A. Expression of sex steroid hormone receptors in human skeletal muscle during the menstrual cycle. Acta Physiol (Oxf). 2017 Feb;219(2):486-493. doi: 10.1111/apha.12757. Epub 2016 Aug 9.

  PMID: 27438889 BACKGROUND

• Ekenros L, Hirschberg AL, Heijne A, Friden C. Oral contraceptives do not affect muscle strength and hop performance in active women. Clin J Sport Med. 2013 May;23(3):202-7. doi: 10.1097/JSM.0b013e3182625a51.

  PMID: 22948447 BACKGROUND

• Ekenros L, Hirschberg AL, Backstrom T, Friden C. Postural control in women with premenstrual symptoms during oral contraceptive treatment. Acta Obstet Gynecol Scand. 2011 Jan;90(1):97-102. doi: 10.1111/j.1600-0412.2010.01021.x. Epub 2010 Nov 26.

  PMID: 21275922 BACKGROUND

• Friden C, Ramsey DK, Backstrom T, Benoit DL, Saartok T, Linden Hirschberg A. Altered postural control during the luteal phase in women with premenstrual symptoms. Neuroendocrinology. 2005;81(3):150-7. doi: 10.1159/000086592. Epub 2005 Jun 28.

  PMID: 15985762 BACKGROUND

• Friden C, Hirschberg AL, Saartok T, Renstrom P. Knee joint kinaesthesia and neuromuscular coordination during three phases of the menstrual cycle in moderately active women. Knee Surg Sports Traumatol Arthrosc. 2006 Apr;14(4):383-9. doi: 10.1007/s00167-005-0663-4. Epub 2005 Jun 8.

  PMID: 15942744 BACKGROUND

• Friden C, Hirschberg AL, Saartok T, Backstrom T, Leanderson J, Renstrom P. The influence of premenstrual symptoms on postural balance and kinesthesia during the menstrual cycle. Gynecol Endocrinol. 2003 Dec;17(6):433-9. doi: 10.1080/09513590312331290358.

  PMID: 14992161 BACKGROUND

• Friden C, Hirschberg AL, Saartok T. Muscle strength and endurance do not significantly vary across 3 phases of the menstrual cycle in moderately active premenopausal women. Clin J Sport Med. 2003 Jul;13(4):238-41. doi: 10.1097/00042752-200307000-00007.

  PMID: 12855926 BACKGROUND

• Hirschberg AL. Challenging Aspects of Research on the Influence of the Menstrual Cycle and Oral Contraceptives on Physical Performance. Sports Med. 2022 Jul;52(7):1453-1456. doi: 10.1007/s40279-021-01616-5. Epub 2022 Jan 22. No abstract available.

  PMID: 35064914 BACKGROUND

• Ekenros L, von Rosen P, Norrbom J, Holmberg HC, Sundberg CJ, Friden C, Hirschberg AL. Impact of Menstrual cycle-based Periodized training on Aerobic performance, a Clinical Trial study protocol-the IMPACT study. Trials. 2024 Jan 29;25(1):93. doi: 10.1186/s13063-024-07921-4.

  PMID: 38287424 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Angelica L Hirschberg, Med dr

CONTACT

+46702559924; angelica.hirschberg.linden@ki.se

Cecilia Fridén, Med dr

CONTACT

+46707415122; cecilia.friden@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The testleader will be blinded to which group the subject belongs to.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: January 25, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

SE (1)