Inflammatory ResponseNCT05934708
Examining the Role of Female Endogenous Sex Hormones in Eccentric Exercise
A study testing Eccentric leg extension in people with Inflammatory Response, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- Eccentric leg extension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- Amenorrhea or oligomenorrhea
- Perimenopausal or menopausal
- Recreational or professional trail or downhill runner
- On a form of contraception
- Cardiac disability
- Pacemaker
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Exercise Research Center
Los Angeles, California, 90033
Bailey McLagan, MS, 323-442-2180, mclagan@usc.edu
About this study
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.
Read the 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
- Being tested
- Eccentric leg extension
- Keywords
- menstrual cycle, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric leg extensionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low estrogen; low progesterone | Experimental | Participants will come in while on their period. During this time estrogen and progesterone concentrations are low. Receives: 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. Receives: 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. Receives: Behavioral: Eccentric leg extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change over time (pre/post, 24 hour, 48 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start7 Mar 2025
- Primary completion30 May 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Schroeder, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934708
- Sponsor's protocol ID
- HS-23-00363
- Status last verified
- Mar 2026
- First submitted
- 20 Jun 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Role of Female Endogenous Sex Hormones in Eccentric Exercise
- ClinicalTrials.gov ID
- NCT05934708
- Acronym / sponsor ID
- HS-23-00363
- Conditions
- Inflammatory Response
- Keywords
- menstrual cycle, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 7 Jul 2023 (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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low estrogen; low progesterone | Experimental | Behavioral: Eccentric leg extensionParticipants will come in while on their period. During this time estrogen and progesterone concentrations are low. |
| High estrogen; low progesterone | Experimental | Behavioral: Eccentric leg extensionParticipants will come in just before ovulation, when estrogen concentrations are high and progesterone concentrations remain low. |
| Medium estrogen; high progesterone | Experimental | Behavioral: Eccentric leg extensionParticipants will come in just after ovulation when estrogen concentrations are at a medium level, and progesterone concentrations are high. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- Amenorrhea or oligomenorrhea
- Perimenopausal or menopausal
- Recreational or professional trail or downhill runner
- On a form of contraception
- Cardiac disability
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 |
|---|---|---|
| Eccentric leg extensionParticipants 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. | Behavioural | High estrogen; low progesterone, Low estrogen; low progesterone, Medium estrogen; high progesterone |
Primary outcome
Preparedness to perform
Time frame: Pre exercise
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
Rating of difficulty
Time frame: 30 minutes
Perceived difficulty will be measured on a 11 point numeric rating scale called the OMNI res throughout the duration of exercise.
Inflammatory markers
Time frame: Change over time (pre/post, 24 hour, 48 hour)
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.
Counter movement jump height
Time frame: Change over time (pre/post, 24 hour, 48 hour)
A countermovement jump (CMJ) will be performed on VALD ForceDecks to determine muscle function overtime.
Passive Delayed Onset Muscle Soreness (DOMS)
Time frame: Change over time (pre/post, 24 hour, 48 hour)
DOMS will be assessed as participants are stationary to assess their perception of muscle damage over time.
Active Delayed Onset Muscle Soreness (DOMS)
Time frame: Change over time (pre/post, 24 hour, 48 hour)
DOMS will be assessed as participants complete a wall sit to assess their perception of muscle soreness over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric leg extension in people with Inflammatory Response, run by University of Southern California at 1 site in United States.
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 10 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Todd Schroeder, PhD (3234422180, eschroed@pt.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preparedness to perform (time frame: Pre exercise). The study lists 6 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 25 Mar 2026.