Healthy WomenNCT06985420
The Effect of the Menstrual Cycle on Immune Cell Activity and Recovery After Resistance Exercise
An observational study of Healthy Women and Menstruation, run by University of Central Florida at 1 site in United States.
Trial summary
The goal of this observational study is to learn how the menstrual cycle affects immune cell activation, recruitment, and recovery responses after resistance exercise in healthy, resistance-trained women aged 18-40. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Healthy Women, Menstruation, Resistance Exercise
- What is being tested?
- Resistance exercise and Menstrual Cycle Phases
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to May 2025
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants will be recruited from the local community and university setting, specifically from the University of Central Florida and surrounding areas. The population will consist of healthy, resistance-trained women aged 18 to 40 who are physically active and meet the criteria for regular menstrual cycles. Participants will likely be university students, staff, or individuals involved in local fitness and sports communities, with a focus on those who are familiar with structured resistance training. Recruitment will aim to reflect a diverse range of backgrounds while ensuring participants meet the health and exercise requirements of the study.
Who may be able to join
- Women between the ages of 18 and 40.
- Must weigh at least 110 pounds.
- Healthy as determined by medical history, physical activity readiness, and menstrual cycle questionnaires.
- Actively resistance training for at least 6 months (minimum of 3 resistance training sessions per week, with at least one lower body session).
- Pre-menopausal and have a regular menstrual cycle (eumenorrheic), with a clear start of menses (early follicular phase).
- Not currently pregnant or planning to become pregnant during the study.
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- Have not used hormonal birth control or intrauterine devices in the past 3 months (or three full menstrual cycles).
- Able to recall approximate start dates of their last 6 menstrual cycles.
- Willing to follow study instructions, including avoiding exercise, alcohol, and caffeine before testing visits.
- Free from previous or current lower body injuries that could limit performance.
- Not regularly taking any medications that could interfere with the study.
- Determined to have a high likelihood of successful blood draws by a certified phlebotomist.
Who cannot join
- Do not give consent to participate.
- Have been determined unfit to participate based on medical or activity history (using health questionnaires).
- Currently take prescription or over-the-counter medication that could affect the study results.
- Have a chronic illness requiring medical care.
- Not currently resistance-trained (don't meet the exercise requirement).
- Pregnant or planning to become pregnant during the study.
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- Do not have regular periods or have been diagnosed as amenorrhoeic (absence of menstruation).
- Currently taking any performance-enhancing drugs.
- Currently using hormonal birth control or intrauterine devices (IUDs), or have used them in the past three months (or three full menstrual cycles).
- Determined unlikely to have a successful blood draw by a trained phlebotomist.
- Weigh less than 110 pounds.
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
University of Central Florida
Orlando, Florida, 32816
Jessica M Moon, 407-823-0623, jessica.moon@ucf.edu
Jessica M Moon
About this study
Official title: The Impact of the Menstrual Cycle on Innate Immune Cell Activation, Recruitment, and Adhesion Dynamics During Recovery From Damaging Resistance Exercise: Role of Neutrophils and Systemic Chemokines.
The goal of this observational study is to learn how the menstrual cycle affects immune cell activation, recruitment, and recovery responses after resistance exercise in healthy, resistance-trained women aged 18-40. The main questions it aims to answer are:
Does the menstrual cycle influence neutrophil recruitment and adhesion after resistance exercise? Does the menstrual cycle affect markers of muscle damage and functional recovery? Researchers will compare three menstrual phases (early follicular, late follicular, and mid-luteal) to see if immune responses and recovery outcomes differ across these phases.
Read more
Participants will:
Complete resistance exercise protocols across three different menstrual cycle phases.
Provide blood samples to assess immune cell activation and muscle damage markers.
Track sleep, mood, and recovery with questionnaires and wear an accelerometer.
- Conditions
- Healthy Women, Menstruation, Resistance Exercise
- Being tested
- Resistance exercise, Menstrual Cycle Phases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
Resistance Exercise Protocols: Participants will perform exercises, including belt squats, hex bar deadlifts, and plyometric drop jumps. The load and intensity will be standardized based on each participant's 1-repetition maximum (1RM) to ensure uniformity across trials.
Menstrual Cycle PhasesOther
Menstrual Cycle Phases: The key exposure variable is the phase of the menstrual cycle, with participants being assessed during the early follicular, late follicular, and mid-luteal phases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil Recruitment and Adhesion Dynamics
Measure: Neutrophil cell index (impedance reflecting neutrophil migration) using Real-Time Cell Analysis (RTCA). Objective: To assess the differences in neutrophil recruitment and adhesion across menstrual cycle phases (early follicular, late follicular, and mid-luteal).
Time Frame: Assessed at 2 time points (baseline and 4 hours post exercise) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Measured: From enrollment, through study completion, an average of 4 months.
Systemic Concentrations of CXCL8
Measure: Plasma levels of CXCL8 (interleukin-8). Objective: To evaluate if menstrual cycle phases influence systemic chemokine levels in response to exercise.
Time Frame: Collected at 2 time points (baseline and 4 hours post exercise) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Measured: From enrollment, through study completion, an average of 4 months.
Muscle Function and Recovery- Active Range of Motion
Measure: Changes in active range of motion (AROM). Objective: To examine the impact of the menstrual cycle on functional recovery following resistance exercise.
Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Measured: From enrollment, through study completion, an average of 4 months.
Muscle Function and Recovery- Pain Pressure Threshold
Measure: Changes in pain pressure threshold (PPT). Objective: To examine the impact of the menstrual cycle on functional recovery following resistance exercise.
Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Measured: From enrollment, through study completion, an average of 4 months.
Muscle Function and Recovery - Countermovement Jump
Measure: Changes in countermovement jump (CMJ) height. Objective: To examine the impact of the menstrual cycle on functional recovery following resistance exercise.
Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Measured: From enrollment, through study completion, an average of 4 months.
Muscle Function and Recovery - Maximal Voluntary Isometric Contraction
Measure: Changes in maximal voluntary isometric contraction (MVIC). Objective: To examine the impact of the menstrual cycle on functional recovery following resistance exercise.
Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Measured: From enrollment, through study completion, an average of 4 months.
Secondary outcomes (12)
Systemic Concentrations of Myoglobin
Measure: Plasma levels of myoglobin (MYB). Objective: To determine how menstrual cycle phases affect muscle damage/inflammation markers after resistance exercise.
Time Frame: Collected at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days per participant (approximately 16 weeks total).
Measured: From enrollment, through study completion, an average of 4 months.
Systemic Concentrations of Creatine kinase
Measure: Plasma levels of creatine kinase (CK). Objective: To determine how menstrual cycle phases affect muscle damage/inflammation markers after resistance exercise.
Time Frame: Collected at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days per participant (approximately 16 weeks total).
Measured: From enrollment, through study completion, an average of 4 months.
Systemic Concentrations of C-Reactive Protein
Measure: Plasma levels of C-reactive protein (CRP). Objective: To determine how menstrual cycle phases affect muscle damage/inflammation markers after resistance exercise.
Time Frame: Collected at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days per participant (approximately 16 weeks total).
Measured: From enrollment, through study completion, an average of 4 months.
Subjective Measures of Perceived Recovery
Measure: Perceived Recovery Status Scale score. Objective: To assess perceived recovery and performance across menstrual cycle phases.
Time Frame: Assessed at 5 time points (baseline, immediately post, 4 hours, 24 hours, and 48 hours post-exercise) on up to 3 experimental trial days (approximately 16 weeks total).
Measured: From enrollment, through study completion, an average of 4 months.
Subjective Measures of Perceived Recovery
Measure: Visual Analog Scale (VAS) ratings for recovery. Objective: To assess perceived recovery across menstrual cycle phases.
Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on up to 4 experimental trial days per participant (approximately 16 weeks total).
Measured: From enrollment, through study completion, an average of 4 months.
Subjective Measures of Fatigue
Measure: Visual Analog Scale (VAS) ratings for fatigue. Objective: To assess perceived fatigue across menstrual cycle phases.
Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days per participant (approximately 16 weeks total).
Measured: From enrollment, through study completion, an average of 4 months.
Subjective Measures of Soreness
Measure: Visual Analog Scale (VAS) ratings for soreness. Objective: To assess perceived soreness across menstrual cycle phases.
Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days per participant (approximately 16 weeks total).
Measured: From enrollment, through study completion, an average of 4 months.
Subjective Sleep Quality
Measure: Groningen Sleep Quality Questionnaire (GSQQ). Objective: To investigate whether menstrual cycle phases impact subjective sleep quality.
Time Frame: Assessed at 3 time points (baseline, 24 hours post, and 48 hours post) on 3 experimental trial days per participant (approximately 16 weeks total)
Measured: Time Frame: From enrollment, through study completion, an average of 4 months.
Subjective Sleep Quality
Measure: Self-Assessment of Sleep Survey (SASS-Y). Objective: To investigate whether menstrual cycle phases impact subjective sleep quality.
Time Frame: Assessed at 1 time point (baseline) on 3 experimental trial days per participant (approximately 16 weeks total)
Measured: From enrollment, through study completion, an average of 4 months.
Objective Sleep Quality
Measure: Actigraph Accelerometer data. Objective: To investigate whether menstrual cycle phases impact objective sleep quality.
Time Frame: Continuously monitored from 72 hours before to 48 hours after exercise on each of 3 experimental trial days (approximately 16 weeks total).
Measured: From enrollment, through study completion, an average of 4 months.
Mood
Measure: Profile of Mood States (POMS). Objective: To examine the influence of the menstrual cycle on mood during recovery from exercise.
Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days per participant (approximately 16 weeks total).
Measured: From enrollment, through study completion, an average of 4 months.
Menstrual Distress
Description: Measure: Menstrual Distress Questionnaire (MEDI-Q). Objective: To examine the influence of the menstrual cycle on menstrual distress reporting. Time Frame: Assessed at 1 time point (baseline) on 3 experimental trial days per participant (approximately 16 weeks total)
Measured: From enrollment, through study completion, an average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start16 Aug 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Moon, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985420
- Sponsor's protocol ID
- STUDY00006956
- Status last verified
- May 2025
- First submitted
- 16 Sep 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Menstrual Cycle on Innate Immune Cell Activation, Recruitment, and Adhesion Dynamics During Recovery From Damaging Resistance Exercise: Role of Neutrophils and Systemic Chemokines.
- ClinicalTrials.gov ID
- NCT06985420
- Acronym / sponsor ID
- STUDY00006956
- Conditions
- Healthy Women, Menstruation, Resistance Exercise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 22 May 2025 (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 goal of this observational study is to learn how the menstrual cycle affects immune cell activation, recruitment, and recovery responses after resistance exercise in healthy, resistance-trained women aged 18-40. The main questions it aims to answer are:
Does the menstrual cycle influence neutrophil recruitment and adhesion after resistance exercise? Does the menstrual cycle affect markers of muscle damage and functional recovery? Researchers will compare three menstrual phases (early follicular, late follicular, and mid-luteal) to see if immune responses and recovery outcomes differ across these phases.
Participants will:
Complete resistance exercise protocols across three different menstrual cycle phases.
Provide blood samples to assess immune cell activation and muscle damage markers.
Track sleep, mood, and recovery with questionnaires and wear an accelerometer.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from the local community and university setting, specifically from the University of Central Florida and surrounding areas. The population will consist of healthy, resistance-trained women aged 18 to 40 who are physically active and meet the criteria for regular menstrual cycles. Participants will likely be university students, staff, or individuals involved in local fitness and sports communities, with a focus on those who are familiar with structured resistance training. Recruitment will aim to reflect a diverse range of backgrounds while ensuring participants meet the health and exercise requirements of the study.
Key inclusion criteria (12 listed)
- Women between the ages of 18 and 40.
- Must weigh at least 110 pounds.
- Healthy as determined by medical history, physical activity readiness, and menstrual cycle questionnaires.
- Actively resistance training for at least 6 months (minimum of 3 resistance training sessions per week, with at least one lower body session).
- Pre-menopausal and have a regular menstrual cycle (eumenorrheic), with a clear start of menses (early follicular phase).
Key exclusion criteria (11 listed)
- Do not give consent to participate.
- Have been determined unfit to participate based on medical or activity history (using health questionnaires).
- Currently take prescription or over-the-counter medication that could affect the study results.
- Have a chronic illness requiring medical care.
- Not currently resistance-trained (don't meet the exercise requirement).
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 |
|---|---|---|
| Resistance exerciseResistance Exercise Protocols: Participants will perform exercises, including belt squats, hex bar deadlifts, and plyometric drop jumps. The load and intensity will be standardized based on each participant's 1-repetition maximum (1RM) to ensure uniformity across trials. | Other | – |
| Menstrual Cycle PhasesMenstrual Cycle Phases: The key exposure variable is the phase of the menstrual cycle, with participants being assessed during the early follicular, late follicular, and mid-luteal phases. | Other | – |
Primary outcome
Neutrophil Recruitment and Adhesion Dynamics
Time frame: From enrollment, through study completion, an average of 4 months.
Measure: Neutrophil cell index (impedance reflecting neutrophil migration) using Real-Time Cell Analysis (RTCA). Objective: To assess the differences in neutrophil recruitment and adhesion across menstrual cycle phases (early follicular, late follicular, and mid-luteal). Time Frame: Assessed at 2 time points (baseline and 4 hours post exercise) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Systemic Concentrations of CXCL8
Time frame: From enrollment, through study completion, an average of 4 months.
Measure: Plasma levels of CXCL8 (interleukin-8). Objective: To evaluate if menstrual cycle phases influence systemic chemokine levels in response to exercise. Time Frame: Collected at 2 time points (baseline and 4 hours post exercise) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Muscle Function and Recovery- Active Range of Motion
Time frame: From enrollment, through study completion, an average of 4 months.
Measure: Changes in active range of motion (AROM). Objective: To examine the impact of the menstrual cycle on functional recovery following resistance exercise. Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Muscle Function and Recovery- Pain Pressure Threshold
Time frame: From enrollment, through study completion, an average of 4 months.
Measure: Changes in pain pressure threshold (PPT). Objective: To examine the impact of the menstrual cycle on functional recovery following resistance exercise. Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Muscle Function and Recovery - Countermovement Jump
Time frame: From enrollment, through study completion, an average of 4 months.
Measure: Changes in countermovement jump (CMJ) height. Objective: To examine the impact of the menstrual cycle on functional recovery following resistance exercise. Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
Muscle Function and Recovery - Maximal Voluntary Isometric Contraction
Time frame: From enrollment, through study completion, an average of 4 months.
Measure: Changes in maximal voluntary isometric contraction (MVIC). Objective: To examine the impact of the menstrual cycle on functional recovery following resistance exercise. Time Frame: Assessed at 5 time points (baseline, immediately post-exercise, 4 hours post, 24 hours post, and 48 hours post) on 3 experimental trial days (1 per menstrual cycle; up to 4 cycles per participant, over approximately 16 weeks).
12 secondary outcomes
Systemic Concentrations of Myoglobin
Time frame: From enrollment, through study completion, an average of 4 months.
Systemic Concentrations of Creatine kinase
Time frame: From enrollment, through study completion, an average of 4 months.
Systemic Concentrations of C-Reactive Protein
Time frame: From enrollment, through study completion, an average of 4 months.
Subjective Measures of Perceived Recovery
Time frame: From enrollment, through study completion, an average of 4 months.
Subjective Measures of Perceived Recovery
Time frame: From enrollment, through study completion, an average of 4 months.
Subjective Measures of Fatigue
Time frame: From enrollment, through study completion, an average of 4 months.
Subjective Measures of Soreness
Time frame: From enrollment, through study completion, an average of 4 months.
Subjective Sleep Quality
Time frame: Time Frame: From enrollment, through study completion, an average of 4 months.
Subjective Sleep Quality
Time frame: From enrollment, through study completion, an average of 4 months.
Objective Sleep Quality
Time frame: From enrollment, through study completion, an average of 4 months.
Mood
Time frame: From enrollment, through study completion, an average of 4 months.
Menstrual Distress
Time frame: From enrollment, through study completion, an average of 4 months.
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 22 May 2025.
- Recruitment WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Healthy Women and Menstruation, run by University of Central Florida 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 12 inclusion and 11 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 22 May 2025. 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 Jessica M Moon (407-823-0623, jessica.moon@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil Recruitment and Adhesion Dynamics (time frame: From enrollment, through study completion, an average of 4 months.). 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 22 May 2025.