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Universidade da Flórida CentralThe Effect of the Menstrual Cycle on Immune Cell Activity and Recovery After Resistance Exercise
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06985420 é um ensaio observacional para Mulheres saudáveis, Menstruação, Exercício de resistência. Seu status atual é: recrutando. O estudo começou em 16 de agosto de 2024 e pretende incluir 40 participantes. Coordenado por a Universidade da Flórida Central e deve ser concluído em 1 de maio de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 22 de maio de 2025.
Resumo
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.
Título oficial
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.
Condições
Mulheres saudáveisMenstruaçãoExercício de resistênciaOutros IDs do estudo
- STUDY00006956
Número NCT
Data de início (real)
2024-08-16
Última atualização postada
2025-05-22
Data de conclusão (estimada)
2025-05
Inscrição (estimada)
40
Tipo de estudo
Observacional
Status
Recrutando
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
N/A | Exercício de resistência 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. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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. |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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. |
Critérios de elegibilidade
Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Feminino
- 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.
Universidade da Flórida Central48 estudos clínicos ativos para explorarResponsável pelo estudo
Jessica Moon, Investigador principal, Graduate Research Assistant, PhD Candidate, Principal Investigator, University of Central Florida
Contato central do estudo
Contato: Jessica M Moon, 407-823-0623, [email protected]
1 Locais do estudo em 1 países
Florida
University of Central Florida, Orlando, Florida, 32816, United States
Jessica M Moon, Contato, 407-823-0623, [email protected]
Jessica M Moon, Investigador principal
Recrutando