Clinical trial NCT05697263: The Impact of the Menstrual Cycle on Physical Exercise and Performance
Official title: The Impact of the Menstrual Cycle on Physical Exercise and Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menstrual Cycle
Exercise
Women's Health
Athletic Performance
Keywords: Menstrual Cycle
Exercise
Women's Health
Athletic Performance
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in aerobic performance
timeFrame: Change from baseline aerobic performance at the end of Cycle 4 (each cycle is around 28 days)
Secondary outcomes:
measure: Change in muscle strength
timeFrame: Change from baseline muscle strength at the end of Cycle 4 (each cycle is around 28 days)
measure: Change in one-leg sit-to-stand test
timeFrame: Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
measure: Change in one-leg hop test for distance
timeFrame: Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
measure: Change in body composition
timeFrame: Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
measure: Change in body composition
timeFrame: Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
measure: Premenstrual symptoms
timeFrame: Every day during the study period
measure: Change in metabolic serum markers
timeFrame: Change from baseline metabolic serum markers at the end of Cycle 4 (each cycle is around 28 days)
measure: Change in mucle morphology
timeFrame: Change from baseline muscle morphology at the end of Cycle 4 (each cycle is around 28 days)
measure: Change in muscle tissue steroid hormones
timeFrame: Change from baseline muscle tissue steroid hormones at the end of Cycle 4 (each cycle is around 28 days)
measure: Change in muscle protein synthesis
timeFrame: Change from baseline muscle protein synthesis at the end of Cycle 4 (each cycle is around 28 days)
measure: Dysmenorrhea
timeFrame: Through study completion, an average of 4 month
Other outcomes:
measure: Confirmation of menstrual cycle phase
timeFrame: Through study completion, an average of 4 months
Locations:
city: Stockholm
country: Sweden
facility: Angelica Lindén Hirschberg
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.