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Menstrual CycleMENSESNCT06679491

Impact of Menstrual Cycle-Based Resistance Training on Neuromuscular Performance in Female Athletes

A study testing Resistance periodized training program (N-PF), Resistance peioridized training program (N-PL) and Continuous resistance training program (C) in people with Menstrual Cycle and Resistance Training, run by Universite de La Reunion at 1 site in Reunion.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 : Does varying resistance training intensity according to menstrual phases improve maximal knee extensor strength? How do… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Resistance periodized training program (N-PF), Resistance peioridized training program (N-PL) and Continuous resistance training program (C)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteReunion
Study dates
1 Nov 2024to 31 Dec 2027
Phase
Interventional
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female athletes with natural menstrual cycles (eumenorrheic): Participants must have regular menstrual cycles lasting between 21 and 35 days, with at least 9 cycles per year.
  • Women using a low-dose monophasic estrogen-progestin oral contraceptive.
  • Age 18 or older: Participants must be legal adults.
  • Body Mass Index (BMI) between 18 and 30 kg/m².
  • No medical contraindications to high-level physical training or exercise.
  • Physically active: Engages in at least 3 hours of physical activity per week.
  • Informed consent: Provides written, informed consent to participate in the study.
  • Affiliation with a social security system (if applicable by local regulations).

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Manon DAUVERGNE, PhD student contact

+262693463288

manon.dauvergne@univ-reunion.fr

Josué GAN, Msc. contact

+33680306613

gan.josue@gmail.com

Reunion1 site, 1 recruiting
  • Laboratoire IRISSE (Université de La Réunion)

    Le Tampon, France, 97430

    Manon DAUVERGNE, PhD, +262693463288, manon.dauvergne@univ-reunion.fr

    Recruiting

Other trials in Reunion

About this study

Official title: Effects of Menstrual Cycle-based Undulating Periodized Resistance Training in Women's Neuromuscular Abilities

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 :

Read more
  • Does varying resistance training intensity according to menstrual phases improve maximal knee extensor strength?
  • How do different training protocols affect voluntary activation, rate of force development, muscle stiffness, and vertical jump height?

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:

  • Undergo 2 weekly resistance training sessions over 13 weeks with intensity adjustments based on menstrual phase
  • Complete periodic neuromuscular assessments across three menstrual phases: early follicular, late follicular, and mid-luteal before and after resistance training intervention
Read the detailed description

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.

Being tested
Resistance periodized training program (N-PF), Resistance peioridized training program (N-PL), Continuous resistance training program (C)
Keywords
Menstrual Cycle, Resistance training, Periodized training, neuromuscular function, Female athlete, Hormones, oral contraceptive pill, women health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance periodized training program (N-PF)Other

    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.

  • Resistance peioridized training program (N-PL)Other

    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.

  • Continuous resistance training program (C)Other

    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.

Study groups in NCT06679491
Study groupRoleWhat they receive
N-PF (Natural Cycle - Follicular Phase-Intensified Training)ExperimentalFemale 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.
Receives: Other: Resistance periodized training program (N-PF)
N-PL (Natural Cycle - Luteal Phase-Intensified Training)ExperimentalDescription: 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.
Receives: Other: Resistance peioridized training program (N-PL)
N-C (Natural Cycle - Continuous Training)ExperimentalDescription: 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.
Receives: Other: Continuous resistance training program (C)
OCP-C (Oral Contraceptive - Continuous Training, Control Group)Active comparatorDescription: 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.
Receives: Other: Continuous resistance training program (C)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline assessment prior to intervention to post-intervention at 13 weeks.

Secondary outcomes (4)
  1. 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.

    Measured: From baseline assessment prior to intervention to post-intervention at 13 weeks

  2. 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.

    Measured: From baseline assessment prior to intervention to post-intervention at 13 weeks.

  3. 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.

    Measured: From baseline assessment prior to intervention to post-intervention at 13 weeks.

  4. 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.

    Measured: From baseline assessment prior to intervention to post-intervention at 13 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2024
  2. Study start1 Nov 2024 (estimated)
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study uses a parallel-group, randomized, controlled interventional model with four arms. Participants are allocated to one of four groups based on menstrual cycle status and training intensity patterns: Three groups consist of female athletes with natural menstrual cycles who are assigned to different training regimens based on specific menstrual phases (higher intensity in either follicular or luteal phases, or a continuous approach). The fourth group includes female athletes on oral contraceptives who follow a continuous training regimen as a control. Each participant completes a 13-week resistance training program with two weekly sessions. Randomization is stratified by BMI and age to ensure balanced group characteristics. The primary objective is to assess changes in neuromuscular function, with each group experiencing variations in training intensity aligned with hormonal influences across menstrual phases.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06679491
Sponsor's protocol ID
ULaReunion
Other IDs
AU1941 - 24.00913.000257
Acronym
MENSES
Status last verified
Nov 2024
First submitted
5 Nov 2024
Last updated
7 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Resistance periodized training program (N-PF), Resistance peioridized training program (N-PL) and Continuous resistance training program (C) in people with Menstrual Cycle and Resistance Training, run by Universite de La Reunion at 1 site in Reunion.

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 8 inclusion and 1 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 7 Nov 2024. 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 Reunion. 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 Manon DAUVERGNE, PhD student (+262693463288, manon.dauvergne@univ-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal knee extensor strenght (time frame: From baseline assessment prior to intervention to post-intervention at 13 weeks.). 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 7 Nov 2024.

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