An interventional study of Resistance periodized training program (N-PF) and Resistance peioridized training program (N-PL) in Menstrual Cycle, Resistance Training and Neuromuscular Function, sponsored by Universite de La Reunion. Recruiting at 1 site in Réunion. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Universite de La Reunion · Not applicable, Interventional, and Basic science
The goal of this clinical trial is to assess the impact of menstrual cycle-based resistance training on neuromuscular function in female athletes.
The primary questions it aims to answer are :
Researchers will compare natural menstrual cycle groups with an oral contraceptive control group to determine if menstrual phase-specific training influences neuromuscular adaptations.
Participants will:
This study investigates the neuromuscular effects of menstrual cycle-based resistance training by comparing three distinct training protocols among female athletes with natural menstrual cycles and a control group of athletes using oral contraceptives. Hormonal fluctuations across the menstrual phases can impact muscle performance, recovery, and neuromuscular function. This trial aims to align training intensity with menstrual cycle phases to enhance neuromuscular adaptations.
Study Design and Population
The trial is a controlled, randomized, open-label design involving 60 recreationally active female athletes aged 18 and above. Participants are allocated into four groups:
N-PF: Natural menstrual cycle with increased training intensity during the follicular phase.
N-PL: Natural menstrual cycle with increased training intensity during the luteal phase.
N-C: Natural menstrual cycle with continuous training intensity across all phases.
OCP-C: Oral contraceptive users with continuous training intensity. Each participant completes a 13-week resistance training program tailored to her group's specific phase-aligned training protocol, with two sessions per week. To assess the neuromuscular impact, we perform pre- and post-intervention evaluations across three key menstrual phases: early follicular, late follicular, and mid-luteal.
Neuromuscular Assessments Primary outcomes include maximal knee extensor strength, assessed through isokinetic testing, and secondary measures cover neuromuscular activation, rate of force development (RFD), muscle stiffness, and vertical jump performance (CMJ). These assessments are conducted during each of the three menstrual phases pre- and post-intervention to capture phase-specific neuromuscular adaptations. Blood sampling for hormonal verification (estradiol and progesterone levels) accompanies each phase-specific testing session.
Methodology and Rationale The training intensity and volume are adjusted based on the participant's menstrual phase to leverage hormonal benefits, with estrogen levels typically promoting muscular strength in the follicular phase and progesterone affecting endurance in the luteal phase. We hypothesize that phase-specific training may yield greater improvements in strength, muscle stiffness, and overall neuromuscular efficiency.
This study's findings are expected to provide novel insights into optimizing training loads for female athletes according to hormonal cycles, with implications for improving performance, reducing injury risk, and advancing individualized training and rehabilitation protocols.
Universite de La Reunion is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Female athletes with natural menstrual cycles who follow a resistance training program with increased intensity during the follicular phase and reduced intensity during the luteal phase. This arm aims to evaluate the impact of follicular-phase-focused training on neuromuscular performance, leveraging the potential effects of elevated estrogen levels during this phase. Intervention: Resistance Training Program: 13 weeks, 2 sessions per week, with higher intensity training scheduled during the follicular phase (early and late) and reduced intensity during the luteal phase.
Other: Resistance periodized training program (N-PF)
Description: Female athletes with natural menstrual cycles who undergo a resistance training program with increased intensity during the luteal phase and reduced intensity during the follicular phase. This approach assesses the impact of training when progesterone levels are elevated. Intervention: Resistance Training Program: 13 weeks, 2 sessions per week, with higher intensity training during the luteal phase (early and late) and reduced intensity during the follicular phase.
Other: Resistance peioridized training program (N-PL)
Description: Female athletes with natural menstrual cycles who participate in a continuous intensity training program across all phases of the menstrual cycle. This group provides a comparison to determine the effects of a non-phase-specific training protocol on neuromuscular function. Intervention: Resistance Training Program: 13 weeks, 2 sessions per week, maintaining a consistent training intensity across both follicular and luteal phases.
Other: Continuous resistance training program (C)
Description: Female athletes using oral contraceptives, following a continuous intensity training program regardless of menstrual phase. This group serves as a control, providing insight into the neuromuscular effects of training under the hormonal conditions set by oral contraceptive use. Intervention: Resistance Training Program: 13 weeks, 2 sessions per week, with continuous intensity across all training sessions due to the stable hormonal environment induced by oral contraceptives.
Other: Continuous resistance training program (C)
This intervention consists of a 13-week structured resistance training program tailored to align with the natural menstrual cycle, focusing on intensified training during the follicular phase. Participants perform two resistance training sessions per week, each lasting 90 minutes, with intensity modulated based on the participant's menstrual phase. Intensity Modulation: Follicular Phase (Days 1-14): Training sessions are performed at a higher training load during both early and late follicular phases. The increased intensity leverages higher estrogen levels, which may support greater muscle strength and recovery during this phase. Luteal Phase (Days 15-28): Training sessions are conducted at a lower training load during both early and late luteal phases to accommodate the hormonal shifts associated with elevated progesterone.
This intervention consists of a 13-week structured resistance training program tailored to align with the natural menstrual cycle, focusing on intensified training during the luteal phase. Participants perform two resistance training sessions per week, each lasting 90 minutes, with intensity modulated according to the participant's menstrual phase. Intensity Modulation: Follicular Phase (Days 1-14): Training sessions are conducted at a lower training load during both early and late follicular phases to accommodate the hormonal environment of this phase. Luteal Phase (Days 15-28): Training sessions are performed at a higher training load during both early and late luteal phases. The increased intensity leverages the hormonal environment associated with elevated progesterone, which may affect muscle endurance and neuromuscular adaptations during this phase.
This intervention consists of a 13-week structured resistance training program with a continuous training intensity maintained throughout the menstrual cycle. Participants perform two resistance training sessions per week, each lasting 90 minutes, with a consistent training load applied across all phases. Intensity Modulation: All Phases: Training sessions are conducted at a steady training load regardless of menstrual phase. This continuous approach is designed to provide a baseline for assessing neuromuscular adaptations without the influence of phase-specific intensity adjustments.
Maximal knee extensor strenght
Description: This outcome measure assesses the maximal isokinetic strength of the knee extensor muscles, measured as peak torque (rotational force) in Newton-meters (Nm), using an isokinetic dynamometer. Scoring and Interpretation: Higher scores indicate greater strength, with no theoretical upper limit as scores are determined by the individual's maximal voluntary contraction. Typical Range: In athletic populations, peak torque values generally range from 100 to 250 Nm, but individual results may vary based on factors like muscle size and training status. Criteria for Change: An improvement in peak torque post-intervention indicates a positive neuromuscular adaptation to the training program. This measure quantifies changes in lower limb strength over time, allowing comparison of neuromuscular adaptations between menstrual phase-aligned and continuous training groups.
Time frame: From baseline assessment prior to intervention to post-intervention at 13 weeks.
Rate of Force Development (RFD)
Evaluates the speed at which force is generated by the knee extensor muscles. This is a key indicator of explosive strength, relevant for sports performance. Measurement: Calculated as the slope of the force-time curve from the onset of muscle contraction. Relevance: Higher RFD values suggest improved neuromuscular response and power output.
Time frame: From baseline assessment prior to intervention to post-intervention at 13 weeks
Active muscle stiffness
Measures the active stiffness of the knee extensor muscles during before and after a fatiguing task, at 50%MVC with a shear wave elastrography (SWE) methods.
Time frame: From baseline assessment prior to intervention to post-intervention at 13 weeks.
Voluntary Muscle Activation (%AV)
Description: Assesses the degree of maximal voluntary activation in the knee extensor muscles before, during and after an "all-out" effort. This test captures the participant's capacity to recruit motor units fully, measured using twitch interpolation technique to evaluate the difference between voluntary and stimulated muscle force output. Relevance: This measure reflects the participant's neuromuscular efficiency by indicating their ability to achieve maximal muscle activation without additional external stimulation. It provides insight into central nervous system drive and the efficiency of motor unit recruitment during intense exertion.
Time frame: From baseline assessment prior to intervention to post-intervention at 13 weeks.
Vertical Jump Height (Countermovement Jump - CMJ)
Measures the maximal height achieved during a countermovement jump, recorded as a functional measure of lower body power. Relevance: Vertical jump height reflects overall lower limb strength and power, providing insight into functional athletic performance.
Time frame: From baseline assessment prior to intervention to post-intervention at 13 weeks.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for Jul 2025, 8 months later.
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