- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07256483
Influence of the Menstrual Cycle on the Maximal Strength of the External and Internal Rotators of the Shoulder in High-level Sports Women.
Influence of the Menstrual Cycle on the Maximal Strength of the External and Internal Rotators of the Shoulder in High-level Sports Women From Montpellier Hérault Rugby.
The goal of this prospective interventional study is to measure the strength of the external and internal rotator muscles of both shoulders (dominant and non-dominant) of Montpellier Hérault Rugby players at different stages of their menstrual cycle. During the menstrual phase (beginning of the follicular phase from D0 to D5) and during the ovulatory/early luteal phase (approximately D13 to D18 of the menstrual cycle). The study is conducted on volunteers.
The main question it aims to answer is : Is there an effect of the menstrual cycle on the maximum strength of the internal and external rotators of the shoulder in female athletes who play rugby?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Montpellier, France, 34430
- Clinique St Jean Sud de France
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria :
- Montpellier Hérault Rugby player
- Regular menstrual cycle
- Adult who has received informed consent information about the study and signed the non-objection form
Exclusion Criteria :
- Use or intake of contraception
- Presence of a condition associated with the menstrual cycle
- Recent injury or pain in the upper limbs lasting more than two weeks, incompatible with performing a test of maximum voluntary contraction of the shoulder rotators
- Presence of an infectious disease (fever) that could skew temperature readings during menstrual cycle monitoring.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: follicular phase
Measures during the follicular phase from D0 to D5
|
Measure the strength of the external and internal rotator muscles of both shoulders using a Cybex-type isokinetic dynamometer.
|
|
Active Comparator: early luteal phase
Measures during the ovulatory/early luteal phase (approximately days 13 to 18 of the menstrual cycle)
|
Measure the strength of the external and internal rotator muscles of both shoulders using a Cybex-type isokinetic dynamometer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intra-individual correlation of isokinetic torque peaks
Time Frame: baseline and 15 days
|
The intra-individual correlation of isokinetic torque peaks (in Nm) measured at two distinct phases of the menstrual cycle (D0-D5 and D13-D18), for each type of internal and external rotator contraction, and for each arm.
|
baseline and 15 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A01018-41
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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