The Impact of the Menstrual Cycle on Physical Exercise and Performance

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of the Menstrual Cycle on Physical Exercise and Performance

Conditions
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Women's Health, Menstrual Cycle, Exercise, Athletic Performance

Intervention / Treatment
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* Other: Periodization of training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Follicle phase based training<br>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<br>* Participants in the three arms will exercise the same dose and number of sessions distributed in three different ways.<br>|
| Experimental: Luteal phase based training<br>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<br>* Participants in the three arms will exercise the same dose and number of sessions distributed in three different ways.<br>|
| Experimental: Regular training<br>Regular training three times a week throughout the menstrual cycle (control group). | Other: Periodization of training<br>* Participants in the three arms will exercise the same dose and number of sessions distributed in three different ways.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle strength | 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 | 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 | 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 | 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 | 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 | Prospective ratings of premenstrual symptoms will be performed with the Cyclicity Diagnoser | Every day during the study period | 
| Change in metabolic serum markers | 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 | Muscle biopsy in mm vastus lateralis | Change from baseline muscle morphology at the end of Cycle 4 (each cycle is around 28 days) | 
| Change in muscle tissue steroid hormones | Muscle biopsy in mm vastus lateralis | Change from baseline muscle tissue steroid hormones at the end of Cycle 4 (each cycle is around 28 days) | 
| Change in muscle protein synthesis | 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 | Questionnaire | Through study completion, an average of 4 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menstrual Cycle, Exercise, Women's Health, Athletic Performance