Examining the Role of Female Endogenous Sex Hormones in Eccentric Exercise

NCT ID: NCT05934708

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2026-08-31

Brief Summary

The fluctuating concentrations of female sex hormones, namely estrogen and progesterone may have an effect on the ability of the tissue to withstand challenging exercise conditions, such as eccentric exercise. These sex hormones have also been purported to influence the perceived difficulty of exercise. This study aims to uncover how the different estrogen and progesterone concentrations present throughout the menstrual cycle effect perceived readiness to perform, perceptions of difficulty, and different recovery metrics.

Detailed Description

Although nearly half of the population is female, less than 10% of research resources are allocated to understanding how their dynamic physiology impacts athletic readiness, performance, and recovery. The fluctuating concentrations of female sex hormones, namely estrogen and progesterone may have an effect on the ability of the tissue to withstand challenging exercise conditions, such as eccentric exercise. This study aims to uncover how the different estrogen and progesterone concentrations present throughout the menstrual cycle effect perceived readiness to perform, perceptions of difficulty, and the inflammatory environment and quantification of muscle damage.

Conditions

Inflammatory Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Low estrogen; low progesterone

Participants will come in while on their period. During this time estrogen and progesterone concentrations are low.

Group Type: EXPERIMENTAL

Eccentric leg extension

Intervention Type: BEHAVIORAL

Participants will complete a 10 x 10 eccentric leg extension on a Cybex Norm dynamometer. Upon arrival, participants will be asked their perceived readiness to perform on a 11 point numeric rating scale. Before the running protocol a baseline blood sample will be collected, as well as passive and active delayed onset muscle soreness (DOMS), a countermovement jump. Half way through each set (i.e., after the 5th repetition) participants will be asked to rank their level of difficulty on a 11 point OMNI Res scale. This will occur during each set. Participants will have follow up blood draws, measures of muscle function (i.e, jump height) and soreness measured immediately after and 24 and 48 hours post-exercise.

High estrogen; low progesterone

Participants will come in just before ovulation, when estrogen concentrations are high and progesterone concentrations remain low.

Group Type: EXPERIMENTAL

Eccentric leg extension

Intervention Type: BEHAVIORAL

Participants will complete a 10 x 10 eccentric leg extension on a Cybex Norm dynamometer. Upon arrival, participants will be asked their perceived readiness to perform on a 11 point numeric rating scale. Before the running protocol a baseline blood sample will be collected, as well as passive and active delayed onset muscle soreness (DOMS), a countermovement jump. Half way through each set (i.e., after the 5th repetition) participants will be asked to rank their level of difficulty on a 11 point OMNI Res scale. This will occur during each set. Participants will have follow up blood draws, measures of muscle function (i.e, jump height) and soreness measured immediately after and 24 and 48 hours post-exercise.

Medium estrogen; high progesterone

Participants will come in just after ovulation when estrogen concentrations are at a medium level, and progesterone concentrations are high.

Group Type: EXPERIMENTAL

Eccentric leg extension

Intervention Type: BEHAVIORAL

Participants will complete a 10 x 10 eccentric leg extension on a Cybex Norm dynamometer. Upon arrival, participants will be asked their perceived readiness to perform on a 11 point numeric rating scale. Before the running protocol a baseline blood sample will be collected, as well as passive and active delayed onset muscle soreness (DOMS), a countermovement jump. Half way through each set (i.e., after the 5th repetition) participants will be asked to rank their level of difficulty on a 11 point OMNI Res scale. This will occur during each set. Participants will have follow up blood draws, measures of muscle function (i.e, jump height) and soreness measured immediately after and 24 and 48 hours post-exercise.

Interventions

Eccentric leg extension

Participants will complete a 10 x 10 eccentric leg extension on a Cybex Norm dynamometer. Upon arrival, participants will be asked their perceived readiness to perform on a 11 point numeric rating scale. Before the running protocol a baseline blood sample will be collected, as well as passive and active delayed onset muscle soreness (DOMS), a countermovement jump. Half way through each set (i.e., after the 5th repetition) participants will be asked to rank their level of difficulty on a 11 point OMNI Res scale. This will occur during each set. Participants will have follow up blood draws, measures of muscle function (i.e, jump height) and soreness measured immediately after and 24 and 48 hours post-exercise.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-35 years of age
• BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths [15]
• Not taking contraception or other types of medication that could influence reproductive status
• Regular menstruation
• Non-pregnant
• Medically free from chronic diseases
• Novel to downhill running
• Weight greater than or equal to 110 lbs
• Not taking exogenous hormones
• Not suffering from known gynecological disease (i.e., PCOS, endometriosis, etc.) that may influence menstrual cycle regularity

Exclusion Criteria

• Amenorrhea or oligomenorrhea
• Perimenopausal or menopausal
• Recreational or professional trail or downhill runner
• On a form of contraception
• Cardiac disability
• Pacemaker
• Arterial disease
• Uncontrolled hemorrhage
• Blood clots
• Pregnant or trying to become pregnant
• Cancerous lesions
• Sensory or mental impairment
• Unstable fractures
• Weight less than 110 lbs
• Suffering from gynecological disease (i.e., PCOS, endometriosis, etc.) that may influence menstrual cycle regularity
• Taking exogenous hormones

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Todd Schroeder

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Exercise Research Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Todd Schroeder, PhD

Role: CONTACT

eschroed@pt.usc.edu

3234422180

Facility Contacts

Bailey McLagan, MS

Role: primary

mclagan@usc.edu

323-442-2180

Other Identifiers

HS-23-00363

Identifier Type: -

Identifier Source: org_study_id