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

NCT ID: NCT05802277

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-05

Study Completion Date

2024-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menstrual Cycle Oral Contraceptive Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Menstrual cycle group

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

Group Type EXPERIMENTAL

Hamstring muscles function assessment

Intervention Type DIAGNOSTIC_TEST

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

Oral contraceptive group

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

Group Type ACTIVE_COMPARATOR

Hamstring muscles function assessment

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hamstring muscles function assessment

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laboratoire Interuniversitaire de Biologie de la Motricité

OTHER

Sponsor Role collaborator

EZUS-LYON 1

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexandre Fouré, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Claude Bernard Lyon 1

Cyril Martin, PhD

Role: STUDY_DIRECTOR

Université Claude Bernard Lyon 1

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Laboratoire Interuniversitaire de Biologie de la Motricité

Villeurbanne, Rhône, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Melanie PRUDENT, MD

Role: CONTACT

33472071862

Jeremie BOUVIER, MSc

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alexandre FOURE, PhD

Role: primary

33472448344

Cyril MARTIN, PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

004B2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hip Activation and FSDT
NCT05642065 COMPLETED NA