Effects of the Menstrual Cycle on Triceps Surae Properties in Women

NCT06214442 | Recruiting

• 1 other identifier: 5.989.983
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menstrual Cycle; Achilles Tendon

Keywords

mechanical properties; material properties; morphological properites; estrogen; progesterone

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (10)

• Cross-sectional area (mm²)

  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 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 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)

  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)

  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).

Study Arms (4)

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

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

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

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

Interventions

Evaluations of the mechanical properties of the achilles tendon in different phases of the menstrual cycle OTHER

Monitoring assessments to verify the effect of different phases of the menstrual cycle on the neuromechanical properties of the Achilles tendon.

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

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.
• 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.
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marco Aurélio Vaz, PhD: lead

Study Sites (1)

Marco Aurelio Vaz

Porto Alegre, Brazil

RECRUITING

Study Officials

• Marco Vaz

  Federal University of Rio Grande do Sul

  STUDY CHAIR

• Marco Vaz

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

• Marco Vaz

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Vaz

CONTACT

5551993851188; marco.vaz@ufrgs.br

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: January 19, 2024
• Study Start: November 10, 2023
• Primary Completion: September 10, 2024
• Study Completion: December 31, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)