Characterization of the Mechanical Properties of the Hamstring Muscle Group in Female.

NCT05802277 | Recruiting

• 1 other identifier: 004B2022
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menstrual Cycle; Oral Contraceptive Use

Keywords

Menstrual cycle; Oral contraception; Muscle mechanical properties; shear wave elastography; Hamstrings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Maximal voluntary force production

  Length of a menstrual cycle (around on 28 day average)

• Hamstring muscles thickness

  Length of a menstrual cycle (around on 28 day average)

• Hamstring muscles length of fascicles

  Length of a menstrual cycle (around on 28 day average)

• Hamstring muscles pennation angle

  Length of a menstrual cycle (around on 28 day average)

• Hamstring muscles cross sectional area

  Length of a menstrual cycle (around on 28 day average)

Study Arms (2)

Menstrual cycle group

EXPERIMENTAL

Women who are not currently taking any form of hormonal contraception and who present a regular menstrual cycle.

Diagnostic Test: Hamstring muscles function assessment

Oral contraceptive group

ACTIVE COMPARATOR

Women taking a second-generation oral contraceptive estrogen-progestogen pill.

Diagnostic Test: Hamstring muscles function assessment

Interventions

Hamstring muscles function assessment DIAGNOSTIC_TEST

Ultrasound echographic evaluation of the hamstring muscles during stretching and voluntary contractions, before and after a strenuous physical activity.

Menstrual cycle group; Oral contraceptive group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• EZUS-LYON 1: lead
• Laboratoire Interuniversitaire de Biologie de la Motricité: collaborator

Study Sites (1)

Laboratoire Interuniversitaire de Biologie de la Motricité

Villeurbanne, Rhône, 69622, France

RECRUITING

Study Officials

• Alexandre Fouré, PhD

  Université Claude Bernard Lyon 1

  PRINCIPAL INVESTIGATOR

• Cyril Martin, PhD

  Université Claude Bernard Lyon 1

  STUDY DIRECTOR

Central Study Contacts

Melanie PRUDENT, MD

CONTACT

33472071862; melanie.prudent@chu-lyon.fr

Jeremie BOUVIER, MSc

CONTACT

jeremie.bouvier@univ-lyon1.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 6, 2023
• Study Start: October 5, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)