Menstrual CycleNCT06214442
Effects of the Menstrual Cycle on Triceps Surae Properties in Women
An observational study of Menstrual Cycle and Achilles Tendon, run by Marco Aurélio Vaz, PhD at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Menstrual Cycle, Achilles Tendon
- What is being tested?
- Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Nov 2023to 31 Dec 2024
- Phase
- Observational
- 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 30 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Menstrual Cycle, Achilles Tendon
- Being tested
- Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle
- Keywords
- mechanical properties, material properties, morphological properites, estrogen, progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycleOther
Monitoring assessments to verify the effect of different phases of the menstrual cycle on the neuromechanical properties of the Achilles tendon.
| Study group | Role | What they receive |
|---|---|---|
| Physically active eumenorrheic women with regular menstrual cycle | Women who practice physical exercise and have regular menstruation ranging from 25 to 38 days. Receives: Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle | |
| Sedentary eumenorrheic women with regular menstrual cycle | Women who do not practice physical exercise and have regular menstruation ranging from 25 to 38 days. Receives: Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle | |
| Physically active women using hormonal contraceptives | Physically active women using oral hormonal contraception combined with estrogen and progesterone within the last six months. Receives: Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle | |
| Sedentary women who use hormonal contraception | Sedentary women using oral hormonal contraception combined with estrogen and progesterone within the last six months. Receives: Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary isometric contraction (Nm)
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
Measured: 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)
Achilles tendon stiffness will be calculated during maximal voluntary contraction in different phases of menstrual cycle and contraception users
Measured: 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 outcomes (10)
Cross-sectional area (mm²)
The evaluation of the cross-sectional area will be carried out using ultrasound, evaluating proximal, medial and distal portions from the calcaneus bone.
Measured: 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
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
Measured: 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)
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.
Measured: 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)
Ankle functionality and ankle dorsiflexion range of motion assessed through functional heel raise theses.
Measured: 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)
Blood concentrations of estrogen and progesterone in different phases of menstrual cycle
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
strain will be evaluated through the relationship relationship between tendon deformation and tendon length at rest. ratio between tendon elongation and TL at rest.
Measured: 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 (%)
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
Measured: 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)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start10 Nov 2023
- Primary completion10 Sep 2024 (estimated)
- Study completion31 Dec 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Aurélio Vaz, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
- Investigators
- Marco Vaz, Study chair, Federal University of Rio Grande do SulMarco Vaz, Study director, Federal University of Rio Grande do SulMarco Vaz, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214442
- Sponsor's protocol ID
- 5.989.983
- Status last verified
- Jun 2024
- First submitted
- 24 Oct 2023
- Last updated
- 10 Jun 2024
- Results posted
- 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 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Menstrual Cycle Phases on Plantar Flexor Neuromechanical Properties and Achilles Tendon Mechanical Properties of Eumenorrheic Women and Hormonal Contraception Users
- ClinicalTrials.gov ID
- NCT06214442
- Acronym / sponsor ID
- 5.989.983
- Conditions
- Menstrual Cycle, Achilles Tendon
- Keywords
- mechanical properties, material properties, morphological properites, estrogen, progesterone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marco Aurélio Vaz, PhDUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Jan 2024 (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 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physically active eumenorrheic women with regular menstrual cycle | – | Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycleWomen who practice physical exercise and have regular menstruation ranging from 25 to 38 days. |
| Sedentary eumenorrheic women with regular menstrual cycle | – | Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycleWomen who do not practice physical exercise and have regular menstruation ranging from 25 to 38 days. |
| Physically active women using hormonal contraceptives | – | Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cyclePhysically active women using oral hormonal contraception combined with estrogen and progesterone within the last six months. |
| Sedentary women who use hormonal contraception | – | Other: Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycleSedentary women using oral hormonal contraception combined with estrogen and progesterone within the last six months. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
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 |
|---|---|---|
| Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycleMonitoring assessments to verify the effect of different phases of the menstrual cycle on the neuromechanical properties of the Achilles tendon. | Other | Physically active eumenorrheic women with regular menstrual cycle, Physically active women using hormonal contraceptives, Sedentary eumenorrheic women with regular menstrual cycle, Sedentary women who use hormonal contraception |
Primary outcome
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
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
10 secondary outcomes
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 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.
Marco Vaz study chair
Federal University of Rio Grande do Sul
Marco Vaz study director
Federal University of Rio Grande do Sul
Marco Vaz principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle and Achilles Tendon, run by Marco Aurélio Vaz, PhD at 1 site in Brazil.
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 11 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 10 Jun 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 Brazil. 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 Marco Vaz (5551993851188, marco.vaz@ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. 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 10 Jun 2024.