Effects of the Menstrual Cycle on Triceps Surae Properties in Women

June 7, 2024 updated by: Marco Aurélio Vaz, PhD

Effects of Menstrual Cycle Phases on Plantar Flexor Neuromechanical Properties and Achilles Tendon Mechanical Properties of Eumenorrheic Women and Hormonal Contraception Users

The menstrual cycle is an important biological rhythm, whereby large cyclic fluctuations in endogenous sex hormones, such as estrogen and progesterone, are observed, which can affect performance. Evidence shows that endogenous and exogenous changes in hormone concentrations during the menstrual cycle exert many effects on the nervous and endocrine systems, in addition to the connective tissue, with consequences for the movement system. Pre-clinical studies (i.e., in animal models) show an estrogen association with the structural and mechanical properties of tendons and ligaments. Several elegant studies performed with female participants have tried to establish the mechanism underlying the effect of estrogen on collagen synthesis and its effects on exercise and functionality. Their findings suggest that the tendon properties may be affected when exposed to varying concentrations of estrogen. The largest tendon in humans, the Achilles tendon, has a direct role in functional capacity, activities of daily living, and locomotion. Studies show that the triceps surae's structural and mechanical properties may change throughout the menstrual cycle, and that these changes are related to endogenous and exogenous fluctuations in estrogen and progesterone. Musculotendinous stiffness, which is dependent on the collagen content, has been seen to vary considerably over the course of the menstrual cycle. In addition, it has been reported that females who have been taking the contraceptive pill for at least a year demonstrate lower levels of tendon strain compared to non-pill taking females, indicating a possible influence of hormonal state on tendon mechanical properties. However, the different experimental designs, the varied approaches to the evaluations and the lack of studies with high methodological quality limit our understanding of the effects of the different phases of the menstrual cycle on the triceps surae's neuromechanical properties. The aim of this observational study will be to investigate whether the morphological, mechanical (active and passive), material, and functional properties of the plantar flexor muscles and of the Achilles tendon, as well as functional parameters, change during voluntary contractions throughout the phases of the menstrual cycle in eumenorrheic women and in users of hormonal contraception. Understanding the acute effects of these properties in eumenorrheic women and users of hormonal contraception is essential so that we can adequately plan interventions and prescriptions of physical exercise and rehabilitation aimed for women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • Porto Alegre, Brazil
        • Recruiting
        • Marco Aurelio Vaz
        • Contact:
          • Marco VAZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Over the last three decades, there has been a rise in the number of women participating in exercise, from physical activity to elite sports. However, the number of studies regarding female participants' performance is still small compared to male participants. The menstrual cycle is an important biological rhythm, whereby large cyclic fluctuations in endogenous sex hormones, such as estrogen and progesterone, are observed, which can affect performance.

Description

Inclusion Criteria:

  • Inclusion criteria for the group of eumenorrheic women

    • Being eumenorrheic with a regular menstrual cycle lasting between 21 and 35 days during the last 6 months prior to study participation.
    • Body Mass Index between 20 and 25 kg/m2.
    • Normal ankle function and range of motion.
    • Do not use hormonal contraception of any kind or supplements hormones for at least the 6 months prior to the study.
    • No complaints of pain or history of lower limb injury.
    • In view of the COVID-19 pandemic, have completed vaccination will be used as an inclusion criteria.
    • For the physically active group, practice regular physical exercise at least 3 times a week for the past 6 months.
    • For the sedentary group, not practicing regular physical exercise in the last 6 months.

Inclusion criteria for the group users of hormonal oral contraception:

  • Body Mass Index between 20 and 25 kg/m2.
  • Normal ankle function and range of motion.
  • Make use of any method of oral hormonal contraception (compressed).
  • Make use of combined oral hormonal contraception with estrogen and progesterone (ethinylestradiol + Drospirenone) for at least 6 months before participating in the study.
  • Do not use other hormone supplements for at least 6 months prior to the study.
  • No complaints of pain or presence of pathologies in the lower limb
  • In view of the COVID-19 pandemic, have completed vaccination will be used as an inclusion criteria.
  • For the physically active group, practice regular physical exercise at least 3 times a week for the past 6 months.
  • For the sedentary group, not practicing regular physical exercise in the last 6 months

Exclusion Criteria:

Exclusion Criteria for eumenorrheic and contraception hormonal groups:

Health problems - contraindication to maximal effort exercise. Additionally, the following subjects will be excluded:

  • Women who have anovulatory cycles or phase lutea deficiency.
  • Women in early menopause.
  • Pregnant or lactating women.
  • Women with oligomenorrhea (menstrual cycles longer than 35 days, or delay of menstruation for the same period).
  • Women with hypothalamic amenorrhea.
  • Female smokers.
  • Women with metabolic syndrome.
  • For women using hormonal contraceptives, women who use adhesive, injectable, intrauterine devices, implants, vaginal rings, as well as progesterone-only CH methods.
  • Does not meet the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Physically active eumenorrheic women with regular menstrual cycle
Women who practice physical exercise and have regular menstruation ranging from 25 to 38 days.
Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle
Monitoring assessments to verify the effect of different phases of the menstrual cycle on the neuromechanical properties of the Achilles tendon.
Sedentary eumenorrheic women with regular menstrual cycle
Women who do not practice physical exercise and have regular menstruation ranging from 25 to 38 days.
Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle
Monitoring assessments to verify the effect of different phases of the menstrual cycle on the neuromechanical properties of the Achilles tendon.
Physically active women using hormonal contraceptives
Physically active women using oral hormonal contraception combined with estrogen and progesterone within the last six months.
Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle
Monitoring assessments to verify the effect of different phases of the menstrual cycle on the neuromechanical properties of the Achilles tendon.
Sedentary women who use hormonal contraception
Sedentary women using oral hormonal contraception combined with estrogen and progesterone within the last six months.
Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle
Monitoring assessments to verify the effect of different phases of the menstrual cycle on the neuromechanical properties of the Achilles tendon.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal voluntary isometric contraction (Nm)
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Maximal voluntary isometric contraction (MVIC) of the plantar flexor muscles, i.e., largest plantar flexor torque generated in different phases of menstrual cycle and different moments of contraception use
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Achilles tendon stiffness (N/mm)
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Achilles tendon stiffness will be calculated during maximal voluntary contraction in different phases of menstrual cycle and contraception users
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cross-sectional area (mm²)
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
The evaluation of the cross-sectional area will be carried out using ultrasound, evaluating proximal, medial and distal portions from the calcaneus bone.
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
tendon stress (MPa) during maximal voluntary contractions
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
The stress will be obtained by taking the ratio between Achilles tendon strength and tendon cross sectional area, and tension taking the relationship between tendon elongation and tendon length at rest
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Myotendinous junction displacement (mm)
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
The displacement of the myotendinous junction of the medial gastrocnemius muscle (DTJM) will be evaluated during passive torque assessment.The analysis will be carried out in three core cycles of the five passive torque cycles.
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Ankle functionality (cm)
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Ankle functionality and ankle dorsiflexion range of motion assessed through functional heel raise theses.
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Blood concentrations (pg/ml)
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Blood concentrations of estrogen and progesterone in different phases of menstrual cycle
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Transvaginal ultrasound (cm)
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Transvaginal ultrasound will be evaluated to control the menstrual cycle and take measurements of the ovary and uterus in the different phases of the menstrual cycle.
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Tendon length (mm²)
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
The length of the tendon will be assessed using ultrasound, starting from the myotendinous junction to the calcaneus bone. The measurement will be carried out with a measuring tape.
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Strain (%) during maximal voluntary contractions
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
strain will be evaluated through the relationship relationship between tendon deformation and tendon length at rest. ratio between tendon elongation and TL at rest.
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Hysteresis (%)
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Hysteresis measurements will be obtained from five cycles, but they will begin at 30° of plantar flexion, and the ankle will be passively moved until maximum dorsal flexion that is achieved. Both passive torque and hysteresis will be evaluated at a constant angular velocity of 5°.s
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Passive torque (Nm)
Time Frame: The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).
Passive torque will be evaluated with the isokinetic method dynamometer moving the ankle passively for five cycles, from 0° (i.e. 90° angle between foot and leg) to the maximum ROM previously determined for each participant.
The assessment will be performed at the beginning (1-4 days), middle (10-14 days), and end (22-26 days) of Cycle 1 (each menstrual cycle is between 28-30 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marco Aurélio Vaz, PhD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Marco Vaz, Federal University of Rio Grande do Sul
  • Study Director: Marco Vaz, Federal University of Rio Grande do Sul
  • Principal Investigator: Marco Vaz, Federal University of Rio Grande do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5.989.983

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

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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