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Universität von ZentralfloridaThe Effect of the Menstrual Cycle on Immune Cell Activity and Recovery After Resistance Exercise
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06985420 ist eine beobachtungsstudie zur Untersuchung von Gesunde Frauen, Menstruation, Widerstandsübung und hat den Status offene rekrutierung. Die Studie startete am 16. August 2024 und soll 40 Teilnehmer aufnehmen. Durchgeführt von Universität von Zentralflorida ist der Abschluss für 1. Mai 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 22. Mai 2025 aktualisiert.
Kurzbeschreibung
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.
Offizieller Titel
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.
Erkrankungen
Gesunde FrauenMenstruationWiderstandsübungWeitere Studien-IDs
- STUDY00006956
NCT-Nummer
Studienbeginn (tatsächlich)
2024-08-16
Zuletzt aktualisiert
2025-05-22
Studienende (vorauss.)
2025-05
Geplante Rekrutierung
40
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Nicht zutreffend | Widerstandstraining 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. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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. |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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. |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Weiblich
- 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.
Universität von Zentralflorida48 aktive klinische Studien zum ErkundenVerantwortliche Partei
Jessica Moon, Hauptprüfer, Graduate Research Assistant, PhD Candidate, Principal Investigator, University of Central Florida
Zentrale Studienkontakte
Kontakt: Jessica M Moon, 407-823-0623, [email protected]
1 Studienstandorte in 1 Ländern
Florida
University of Central Florida, Orlando, Florida, 32816, United States
Jessica M Moon, Kontakt, 407-823-0623, [email protected]
Jessica M Moon, Hauptprüfer
Offene Rekrutierung