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Università della Florida CentraleThe Effect of the Menstrual Cycle on Immune Cell Activity and Recovery After Resistance Exercise
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La sperimentazione clinica NCT06985420 è uno studio osservazionale per Donne sane, Mestruazione, Esercizio di resistenza, attualmente in arruolamento. Avviato il 16 agosto 2024, prevede di arruolare 40 partecipanti. Sotto la guida di l'Università della Florida Centrale, dovrebbe concludersi entro il 1 maggio 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 22 maggio 2025.
Sommario breve
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.
Titolo ufficiale
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.
Condizioni
Donne saneMestruazioneEsercizio di resistenzaAltri ID dello studio
- STUDY00006956
Numero NCT
Data di inizio (effettiva)
2024-08-16
Ultimo aggiornamento pubblicato
2025-05-22
Data di completamento (stimata)
2025-05
Arruolamento (previsto)
40
Tipo di studio
Osservazionale
Stato
In arruolamento
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
N.D. | Esercizio di resistenza 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 Phases 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. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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). | 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). | 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). | 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). | 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). | 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). | From enrollment, through study completion, an average of 4 months. |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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). | 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). | 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). | 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). | 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). | 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). | 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). | 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) | 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) | 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). | 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). | 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) | From enrollment, through study completion, an average of 4 months. |
Criteri di eleggibilità
Età idonea
Adulto
Età minima
18 Years
Sessi idonei
Donna
- 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.
- 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.
- 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.
- 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.
Università della Florida Centrale48 studi clinici attivi da esplorareParte responsabile dello studio
Jessica Moon, Investigatore principale, Graduate Research Assistant, PhD Candidate, Principal Investigator, University of Central Florida
Contatti principali dello studio
Contatto: Jessica M Moon, 407-823-0623, [email protected]
1 Centri dello studio in 1 paesi
Florida
University of Central Florida, Orlando, Florida, 32816, United States
Jessica M Moon, Contatto, 407-823-0623, [email protected]
Jessica M Moon, Investigatore principale
In arruolamento