The Impact of the Menstrual Cycle on Physical Exercise and Performance

Sponsor

Karolinska Institutet (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05697263

Collaborator

(none)

111

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Cycle Exercise Women's Health Athletic Performance	Other: Periodization of training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The testleader will be blinded to which group the subject belongs to.

Primary Purpose:

Basic Science

Official Title:

The Impact of the Menstrual Cycle on Physical Exercise and Performance

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.	Other: Periodization of training 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.	Other: Periodization of training 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).	Other: Periodization of training Participants in the three arms will exercise the same dose and number of sessions distributed in three different ways.

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.

Other: Periodization of training

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.

Other: Periodization of training

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).

Other: Periodization of training

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

Outcome Measures

Primary Outcome Measures

Change in aerobic performance [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.

Secondary Outcome Measures

Change in muscle strength [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 in one-leg sit-to-stand test [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 in one-leg hop test for distance [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 in body composition [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 in body composition [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).
Premenstrual symptoms [Every day during the study period]
Prospective ratings of premenstrual symptoms will be performed with the Cyclicity Diagnoser
Change in metabolic serum markers [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 in mucle morphology [Change from baseline muscle morphology at the end of Cycle 4 (each cycle is around 28 days)]
Muscle biopsy in mm vastus lateralis
Change in muscle tissue steroid hormones [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
Change in muscle protein synthesis [Change from baseline muscle protein synthesis at the end of Cycle 4 (each cycle is around 28 days)]
Muscle biopsy in mm vastus lateralis
Dysmenorrhea [Through study completion, an average of 4 month]
Questionnaire

Other Outcome Measures

Confirmation of menstrual cycle phase [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Angelica Hirschberg Lindén, Professor, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT05697263

Other Study ID Numbers:

2021-01650

First Posted:

Jan 25, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Angelica Hirschberg Lindén, Professor, Karolinska Institutet

Study Results

No Results Posted as of Jan 25, 2023