Effects of the Menstrual Cycle on Triceps Surae Properties in Women

Menstrual Cycle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214442
• Other study ID #: 5.989.983
• Status: Recruiting
• Start date: November 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Federal University of Rio Grande do Sul
• Contact: Marco Vaz
• Phone: 5551993851188
• Email: marco.vaz[@]ufrgs.br
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendon
• Menstrual Cycle

Intervention

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.

Locations

Country	Name	City	State
Brazil	Marco Aurelio Vaz	Porto Alegre

Sponsors (1)

Lead Sponsor	Collaborator
Marco Aurélio Vaz, PhD

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Primary	Achilles tendon stiffness (N/mm)	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	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.	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	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	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	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.	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	Ankle functionality (cm)	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).
Secondary	Blood concentrations (pg/ml)	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).
Secondary	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.	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	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.	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	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.	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	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	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	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.	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).