Examining the Role of Female Endogenous Sex Hormones in Eccentric Exercise

NCT05934708 | Recruiting

• 1 other identifier: HS-23-00363
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Response

Keywords

menstrual cycle; exercise

Outcome Measures

Primary Outcomes (6)

• Preparedness to perform

  Perceived readiness will be measured on an 11 point numeric rating scale (NRS) with 0 being not ready at all, and 10 being most prepared

  Pre exercise

• Rating of difficulty

  Perceived difficulty will be measured on a 11 point numeric rating scale called the OMNI res throughout the duration of exercise.

  30 minutes

• Inflammatory markers

  Inflammatory markers (IL-6, IL-8, TNF-alpha, and IL-10) will be measured in blood serum to understand how the concentration of estrogen changes the inflammatory response to damaging exercise.

  Change over time (pre/post, 24 hour, 48 hour)

• Counter movement jump height

  A countermovement jump (CMJ) will be performed on VALD ForceDecks to determine muscle function overtime.

  Change over time (pre/post, 24 hour, 48 hour)

• Passive Delayed Onset Muscle Soreness (DOMS)

  DOMS will be assessed as participants are stationary to assess their perception of muscle damage over time.

  Change over time (pre/post, 24 hour, 48 hour)

• Active Delayed Onset Muscle Soreness (DOMS)

  DOMS will be assessed as participants complete a wall sit to assess their perception of muscle soreness over time.

  Change over time (pre/post, 24 hour, 48 hour)

Study Arms (3)

Low estrogen; low progesterone

EXPERIMENTAL

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

Behavioral: Eccentric leg extension

High estrogen; low progesterone

EXPERIMENTAL

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

Behavioral: Eccentric leg extension

Medium estrogen; high progesterone

EXPERIMENTAL

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

Behavioral: Eccentric leg extension

Interventions

Eccentric leg extension 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; Low estrogen; low progesterone; Medium estrogen; high progesterone

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: All participants will be cis-gendered female. This is to control for the potential influence that differing hormonal profiles have on transgender and nonbinary female athletes.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Clinical Exercise Research Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Todd Schroeder, PhD

CONTACT

3234422180; eschroed@pt.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 7, 2023
• Study Start: March 7, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)