Menstrual CycleMECA_CYCLENCT05802277
Characterization of the Mechanical Properties of the Hamstring Muscle Group in Female.
A study testing Hamstring muscles function assessment in people with Menstrual Cycle and Oral Contraceptive Use, run by EZUS-LYON 1 at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Oral Contraceptive Use
- What is being tested?
- Hamstring muscles function assessment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Jeremie BOUVIER, MSc contact
France1 site, 1 recruiting
- Recruiting
Laboratoire Interuniversitaire de Biologie de la Motricité
Villeurbanne, Rhône, 69622
Alexandre FOURE, PhD, 33472448344, alexandre.foure@univ-lyon1.fr
Cyril MARTIN, PhD, cyril.martin@univ-lyon1.fr
About this study
Official title: 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.
- Conditions
- Menstrual Cycle, Oral Contraceptive Use
- Being tested
- Hamstring muscles function assessment
- Keywords
- Menstrual cycle, Oral contraception, Muscle mechanical properties, shear wave elastography, Hamstrings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamstring muscles function assessmentDiagnostic test
Ultrasound echographic evaluation of the hamstring muscles during stretching and voluntary contractions, before and after a strenuous physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Menstrual cycle group | Experimental | Women who are not currently taking any form of hormonal contraception and who present a regular menstrual cycle. Receives: Diagnostic Test: Hamstring muscles function assessment |
| Oral contraceptive group | Active comparator | Women taking a second-generation oral contraceptive estrogen-progestogen pill. Receives: Diagnostic Test: Hamstring muscles function assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstring muscles shear wave speed
Differences according to menstrual cycle phase in hamstring muscles shear wave speed, as measured by ultrasound elastography
Measured: Length of a menstrual cycle (around on 28 day average)
Secondary outcomes (7)
Maximal voluntary force production
Differences according to menstrual cycle phase in maximal voluntary isometric hamstrings force production, as measured by an isokinetic dynamometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Length of a menstrual cycle (around on 28 day average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start5 Oct 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EZUS-LYON 1
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Interuniversitaire de Biologie de la Motricité
- Responsible party
- Sponsor
- Investigators
- Alexandre Fouré, PhD, Principal investigator, Université Claude Bernard Lyon 1Cyril Martin, PhD, Study director, Université Claude Bernard Lyon 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802277
- Sponsor's protocol ID
- 004B2022
- Acronym
- MECA_CYCLE
- Status last verified
- Feb 2024
- First submitted
- 3 Mar 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Mechanical Properties of the Hamstring Muscle Group in Female Athletes: Impact of the Menstrual Cycle and Adaptations to Exercise.
- ClinicalTrials.gov ID
- NCT05802277
- Acronym / sponsor ID
- MECA_CYCLE / 004B2022
- Conditions
- Menstrual Cycle, Oral Contraceptive Use
- Keywords
- Menstrual cycle, Oral contraception, Muscle mechanical properties, shear wave elastography, Hamstrings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- EZUS-LYON 1University, hospital or other
- Collaborators
- Laboratoire Interuniversitaire de Biologie de la Motricité
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menstrual cycle group | Experimental | Diagnostic Test: Hamstring muscles function assessmentWomen who are not currently taking any form of hormonal contraception and who present a regular menstrual cycle. |
| Oral contraceptive group | Active comparator | Diagnostic Test: Hamstring muscles function assessmentWomen taking a second-generation oral contraceptive estrogen-progestogen pill. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamstring muscles function assessmentUltrasound echographic evaluation of the hamstring muscles during stretching and voluntary contractions, before and after a strenuous physical activity. | Diagnostic test | Menstrual cycle group, Oral contraceptive group |
Primary outcome
Hamstring muscles shear wave speed
Time frame: Length of a menstrual cycle (around on 28 day average)
Differences according to menstrual cycle phase in hamstring muscles shear wave speed, as measured by ultrasound elastography
7 secondary outcomes
Maximal voluntary force production
Time frame: Length of a menstrual cycle (around on 28 day average)
Hamstring muscles thickness
Time frame: Length of a menstrual cycle (around on 28 day average)
Hamstring muscles length of fascicles
Time frame: Length of a menstrual cycle (around on 28 day average)
Hamstring muscles pennation angle
Time frame: Length of a menstrual cycle (around on 28 day average)
Hamstring muscles cross sectional area
Time frame: Length of a menstrual cycle (around on 28 day average)
Hamstring tendons length
Time frame: Length of a menstrual cycle (around on 28 day average)
Maximal knee joint range of motion
Time frame: Length of a menstrual cycle (around on 28 day average)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremie BOUVIER, MSc contact
Alexandre Fouré, PhD principal investigator
Université Claude Bernard Lyon 1
Cyril Martin, PhD study director
Université Claude Bernard Lyon 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hamstring muscles function assessment in people with Menstrual Cycle and Oral Contraceptive Use, run by EZUS-LYON 1 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie PRUDENT, MD (33472071862, melanie.prudent@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamstring muscles shear wave speed (time frame: Length of a menstrual cycle (around on 28 day average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.