- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462286
Menstrual Cycle and Women's Performance
The Relationship Between the Menstrual Cycle and Physical Performance in Women
This study examines how different phases of the menstrual cycle are associated with selected performance and musculoskeletal parameters in physically active women aged 18-35 years.
Participants will track their menstrual cycle using a mobile app for approximately 2 months and attend 3 laboratory visits scheduled to specific cycle phases.
At each visit, participants will complete non-invasive assessments including lower-limb strength/performance testing, musculoskeletal measurements (muscle and tendon properties), body composition assessment, and symptom-related questionnaires.
The goal is to improve understanding of physiological variability across the menstrual cycle and support evidence-based planning of training, testing, and clinical practice in women.
Study Overview
Status
Conditions
Detailed Description
Background and rationale:
Female physiology changes across menstrual cycle phases, which may influence neuromuscular performance, perceived symptoms, and selected tissue/mechanical properties. Current evidence is heterogeneous, partly due to methodological differences in cycle-phase identification and measurement protocols. This study aims to provide standardized data from repeated within-subject assessments across the menstrual cycle.
Objectives:
Primary objective is to evaluate associations between menstrual cycle phase and selected performance-related outcomes in physically active women.
Secondary objectives are to explore phase-related differences in musculoskeletal parameters, body composition outputs, and self-reported symptoms.
Study design:
Prospective, repeated-measures observational study. Each participant is measured repeatedly across predefined menstrual cycle phases.
Participants:
Women from the general population, 18-35 years, with occasional to recreational physical activity level.
Procedures:
Screening and eligibility confirmation according to protocol criteria.
Menstrual cycle tracking via mobile application for approximately 2 months.
Three laboratory visits timed to predefined cycle phases.
At each visit, non-invasive assessments are performed, including:
lower-limb strength/performance testing,
assessment of muscle and tendon mechanical properties,
body composition measurement,
recording of subjectively perceived menstrual-related symptoms.
Outcomes:
Main outcomes include phase-specific differences/associations in selected performance and musculoskeletal variables; additional outcomes include symptom profiles and selected body-composition variables.
Duration and setting:
Individual participation lasts approximately 2 months including cycle tracking and 3 lab visits (approximately 60-90 minutes per visit). Study procedures are conducted at FTVS UK (Prague).
Ethics and data protection:
Participation is voluntary, and participants may withdraw at any time without giving a reason. Data are processed in compliance with applicable data-protection regulations (including GDPR), pseudonymized for analysis, and reported in aggregate/anonymized form. The study is conducted according to institutional ethics approval and the Declaration of Helsinki.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vendula Soukupová, Mgr.
- Phone Number: +420775976312
- Email: vendula.soukupova@ftvs.cuni.cz
Study Locations
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-
Prague
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Prague, Prague, Czechia, 16252
- Faculty of Physical Education and Sport, Charles University, José Martího 269/31
-
Contact:
- Vendula Soukupová, Mgr.
- Phone Number: +420775976312
- Email: vendula.soukupova@ftvs.cuni.cz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female, age 18-35 years
Premenopausal
Occasional to recreational level of physical activity
Willing and able to track menstrual cycle using a mobile application for approximately 2 months
Willing and able to attend 3 laboratory visits scheduled to predefined menstrual cycle phases
Able to provide written informed consent
Exclusion Criteria:
- Irregular menstrual cycle (outside protocol-defined regularity)
Current pregnancy
Use of hormonal medication for therapeutic purposes (per protocol)
Current acute illness at time of testing
Musculoskeletal injury of the lower limb limiting safe performance testing
Contraindication to body composition assessment methods used in the study (e.g., BIA/DXA, per site protocol)
Any other condition that, in the investigator's judgment, may interfere with safe participation or data quality
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Physically Active Women (18-35 years)
Women aged 18-35 years from the general population with occasional to recreational physical activity level.
Participants undergo repeated non-invasive assessments across predefined menstrual cycle phases, including performance testing, musculoskeletal measurements, body composition assessment, and symptom tracking.
|
Menstrual cycle monitoring using a mobile application for approximately 2 months to schedule laboratory visits to predefined cycle phases.
Repeated lower-limb performance/strength assessments during laboratory visits in different menstrual cycle phases.
Non-invasive assessment of selected muscle and tendon mechanical properties across cycle phases.
Body composition measurement and collection of self-reported menstrual-related symptoms at laboratory visits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phase-specific change in lower-limb neuromuscular performance across the menstrual cycle
Time Frame: Assessed at 3 laboratory visits across approximately 2 months (cycle tracking period)
|
Within-subject differences in lower-limb performance/strength outcomes measured during three laboratory visits scheduled to predefined menstrual cycle phases.
|
Assessed at 3 laboratory visits across approximately 2 months (cycle tracking period)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phase-specific differences in muscle mechanical properties
Time Frame: Assessed at 3 laboratory visits across approximately 2 months
|
Within-subject changes in selected skeletal muscle mechanical properties measured non-invasively across predefined menstrual cycle phases.
|
Assessed at 3 laboratory visits across approximately 2 months
|
|
Phase-specific differences in tendon mechanical properties
Time Frame: Assessed at 3 laboratory visits across approximately 2 months
|
Within-subject changes in selected tendon mechanical properties measured non-invasively across predefined menstrual cycle phases.
|
Assessed at 3 laboratory visits across approximately 2 months
|
|
Phase-specific differences in body composition variables
Time Frame: Assessed at 3 laboratory visits across approximately 2 months
|
Within-subject differences in body composition parameters assessed at laboratory visits scheduled to predefined menstrual cycle phases.
|
Assessed at 3 laboratory visits across approximately 2 months
|
|
Menstrual-related symptom profile across menstrual cycle phases
Time Frame: Collected during cycle tracking and at 3 laboratory visits across approximately 2 months
|
Self-reported menstrual-related symptoms recorded via questionnaires/standardized symptom reporting and compared across predefined cycle phases.
|
Collected during cycle tracking and at 3 laboratory visits across approximately 2 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- body composition
- observational study
- women's health
- luteal phase
- muscle mechanical properties
- follicular phase
- female athletes
- neuromuscular performance
- repeated measures
- symptom tracking
- menstrual cycle phase
- lower limb strength
- physically active women
- tendon mechanical properties
- cycle tracking app
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK 008/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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