- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05697263
The Impact of the Menstrual Cycle on Physical Exercise and Performance
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Angelica L Hirschberg, Med dr
- Phone Number: +46702559924
- Email: angelica.hirschberg.linden@ki.se
Study Contact Backup
- Name: Cecilia Fridén, Med dr
- Phone Number: +46707415122
- Email: cecilia.friden@ki.se
Study Locations
-
-
-
Stockholm, Sweden, 17176
- Recruiting
- Angelica Lindén Hirschberg
-
Contact:
- Angelica L Hirschberg, Professor
- Email: angelica.linden-hirschberg@regionstockholm.se
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Contact:
- Cecilia Fridén, Ass Prof
- Phone Number: 0046707415122
- Email: cecilia.friden@ki.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Follicle phase based training
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.
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Participants in the three arms will exercise the same dose and number of sessions distributed in three different ways.
|
|
Experimental: Luteal phase based training
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.
|
Participants in the three arms will exercise the same dose and number of sessions distributed in three different ways.
|
|
Experimental: Regular training
Regular training three times a week throughout the menstrual cycle (control group).
|
Participants in the three arms will exercise the same dose and number of sessions distributed in three different ways.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in aerobic performance
Time Frame: Change from baseline aerobic performance at the end of Cycle 4 (each cycle is around 28 days)
|
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.
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Change from baseline aerobic performance at the end of Cycle 4 (each cycle is around 28 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in muscle strength
Time Frame: Change from baseline muscle strength at the end of Cycle 4 (each cycle is around 28 days)
|
A standardized isokinetic device (Biodex®, Corp, Shirley, NY, USA) will be used for measurements of maximal muscle torque (Nm) in the leg extensor muscles at 90 and 120 gr/sec (11).
Change in muscle strength from baseline to end of study will be compared between groups.
|
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
Time Frame: Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
|
Assessment of functional muscle strength in the lower extremities.
|
Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
|
|
Change in one-leg hop test for distance
Time Frame: Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
|
Assessment of functional muscle strength in the lower extremities.
|
Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
|
|
Change in body composition
Time Frame: Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
|
Differences in body fat (%) will be determined by DXA (Lunar equipment).
|
Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
|
|
Change in body composition
Time Frame: Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
|
Differences in muscle mass (g), will be determined by DXA (Lunar equipment).
|
Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
|
|
Premenstrual symptoms
Time Frame: Every day during the study period
|
Prospective ratings of premenstrual symptoms will be performed with the Cyclicity Diagnoser
|
Every day during the study period
|
|
Change in metabolic serum markers
Time Frame: Change from baseline metabolic serum markers at the end of Cycle 4 (each cycle is around 28 days)
|
Blood samples for analysis of IGF-1.
|
Change from baseline metabolic serum markers at the end of Cycle 4 (each cycle is around 28 days)
|
|
Change in mucle morphology
Time Frame: Change from baseline muscle morphology at the end of Cycle 4 (each cycle is around 28 days)
|
Muscle biopsy in mm vastus lateralis
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Change from baseline muscle morphology at the end of Cycle 4 (each cycle is around 28 days)
|
|
Change in muscle tissue steroid hormones
Time Frame: Change from baseline muscle tissue steroid hormones at the end of Cycle 4 (each cycle is around 28 days)
|
Muscle biopsy in mm vastus lateralis
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Change from baseline muscle tissue steroid hormones at the end of Cycle 4 (each cycle is around 28 days)
|
|
Change in muscle protein synthesis
Time Frame: Change from baseline muscle protein synthesis at the end of Cycle 4 (each cycle is around 28 days)
|
Muscle biopsy in mm vastus lateralis
|
Change from baseline muscle protein synthesis at the end of Cycle 4 (each cycle is around 28 days)
|
|
Dysmenorrhea
Time Frame: Through study completion, an average of 4 month
|
Questionnaire
|
Through study completion, an average of 4 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Confirmation of menstrual cycle phase
Time Frame: Through study completion, an average of 4 months
|
Blood sampels will be collected at early follicular phase, ovulation phase and mid luteal phase for analysis of LH, FSH, estradiol and progesterone.
|
Through study completion, an average of 4 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-01650
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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