Characterization of the Mechanical Properties of the Hamstring Muscle Group in Female. (MECA_CYCLE)

Characterization of the Mechanical Properties of the Hamstring Muscle Group in Female Athletes: Impact of the Menstrual Cycle and Adaptations to Exercise.

The goal of this clinical trial is to precise the impact of menstrual cycle and physical activity on the hamstrings muscle function in healthy active women. The main question it aims to answer is : is there a moment of the menstrual cycle when the muscle is better able to recover from a strenuous exercise ? Three appointments will be conducted to evaluate the hamstring muscles at difference moments of the menstrual cycle. Echographic and maximal force production measures will be done.

Researchers will compare these results with a group taking oral contraceptives.

Study Overview

• Status: Recruiting
• Conditions: Menstrual Cycle; Oral Contraceptive Use
• Intervention / Treatment: Diagnostic test: Hamstring muscles function assessment

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie PRUDENT, MD; Phone Number: 33472071862; Email: melanie.prudent@chu-lyon.fr
• Study Contact Backup: Name: Jeremie BOUVIER, MSc; Email: jeremie.bouvier@univ-lyon1.fr

Study Locations

• France
  • Rhône
    • Villeurbanne, Rhône, France, 69622
      • Recruiting
      • Laboratoire Interuniversitaire de Biologie de la Motricité
      • Contact: Alexandre FOURE, PhD; Phone Number: 33472448344; Email: alexandre.foure@univ-lyon1.fr
      • Contact: Cyril MARTIN, PhD; Email: cyril.martin@univ-lyon1.fr
      • Principal Investigator: Alexandre FOURE, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subject aged between 18 and 35 years.
• Subjects who practice at least 2 hours of sport per week with a competitive aim.
• Subject who has not presented any musculo-tendinous pathology to the hamstrings in the last 6 months.
• Subject with no musculoarticular pathology having a prolonged (more than 2 weeks) interruption of sports activities in the last 2 years.
• Subject with no muscular pain or pathology currently.
• Subject with no known cardiac disorders or family history that could present a risk known family history that could present a risk in case of intense physical effort.

physical exertion.

• Subjects not taking any medication, which in the opinion of the that, in the opinion of the coordinating investigator, may interfere with the evaluation of the study criteria.
• Subject able and willing to comply with the protocol and agreeing to give written informed consent.
• Subject affiliated or benefiting from a Social Security plan.

Menstrual cycle group:

• Subject whose last 3 menstrual cycles are of a regular duration (± 4 days maximum difference between 2 consecutive menstrual cycles).
• Subject whose last 3 menstrual cycles are of a duration between 24 and 32 days (including milestones).
• Absence of any contraceptive method likely to modulate the hormonal variations linked to the menstrual cycle.

hormonal variations related to the menstrual cycle, during the duration of the duration of the protocol and during the last 6 months after the participant's inclusion.

the participant. Mechanical contraception such as the diaphragm is permitted.

Oral contraceptive group:

- Taking oral contraception, 2nd generation monophasic pill estrogen-progestin pill (Optilova®, Optidril®, Leeloo®, Minidril®, Ludeal®, Zikiale®, Lovavulo®, Lovapharm®) for at least 6 months.

Exclusion Criteria:

• Subjects with a medical contraindication to intense physical activity.
• Subject with a positive pregnancy test result.
• Subject with a medical or surgical history deemed by the coordinating investigator as being incompatible with the study.
• Subjects under guardianship.
• Subjects in a period of exclusion from another study.
• Decision of the volunteer, whatever the reason.
• Adverse event or effect affecting the safety of the volunteer in the opinion of the coordinating investigator.
• Major deviation from the protocol.
• Illness or injury interfering with the normal course of the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menstrual cycle group; Women who are not currently taking any form of hormonal contraception and who present a regular menstrual cycle.	Diagnostic test: Hamstring muscles function assessment; Ultrasound echographic evaluation of the hamstring muscles during stretching and voluntary contractions, before and after a strenuous physical activity.
Active Comparator: Oral contraceptive group; Women taking a second-generation oral contraceptive estrogen-progestogen pill.	Diagnostic test: Hamstring muscles function assessment; Ultrasound echographic evaluation of the hamstring muscles during stretching and voluntary contractions, before and after a strenuous physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamstring muscles shear wave speed	Differences according to menstrual cycle phase in hamstring muscles shear wave speed, as measured by ultrasound elastography	Length of a menstrual cycle (around on 28 day average)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal voluntary force production	Differences according to menstrual cycle phase in maximal voluntary isometric hamstrings force production, as measured by an isokinetic dynamometer	Length of a menstrual cycle (around on 28 day average)
Hamstring muscles thickness	Differences according to menstrual cycle phase in hamstring muscles thickness, as measured by ultrasound echography.	Length of a menstrual cycle (around on 28 day average)
Hamstring muscles length of fascicles	Differences according to menstrual cycle phase in hamstring muscles fascicles' length, as measured by ultrasound echography.	Length of a menstrual cycle (around on 28 day average)
Hamstring muscles pennation angle	Differences according to menstrual cycle phase in hamstring muscles pennation angle, as measured by ultrasound echography.	Length of a menstrual cycle (around on 28 day average)
Hamstring muscles cross sectional area	Differences according to menstrual cycle phase in hamstring muscles cross sectional area, as measured by ultrasound echography.	Length of a menstrual cycle (around on 28 day average)
Hamstring tendons length	Differences according to menstrual cycle phase in hamstring tendons length, as measured by ultrasound echography.	Length of a menstrual cycle (around on 28 day average)
Maximal knee joint range of motion	Measure of the volunteer maximal knee range of motion, the maximum being defined by the volunteer as the greatest hip/leg angle reachable without feeling pain. The process is slowly conducted on an isokinetic ergometer by extending the knee joint (2°/s) until the volunteer reaches her maximal range of motion, at which point the movement is stopped and a security is placed.	Length of a menstrual cycle (around on 28 day average)

Collaborators and Investigators

• Sponsor: EZUS-LYON 1
• Collaborators: Laboratoire Interuniversitaire de Biologie de la Motricité
• Investigators: Principal Investigator: Alexandre Fouré, PhD, Université Claude Bernard Lyon 1; Study Director: Cyril Martin, PhD, Université Claude Bernard Lyon 1

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Oral contraception; shear wave elastography; Menstrual cycle; Hamstrings; Muscle mechanical properties
• Other Study ID Numbers: 004B2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No