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

NCT ID: NCT06679491

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-12-31

Brief Summary

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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 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

Detailed Description

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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.

Conditions

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Menstrual Cycle Resistance Training Neuromuscular Function Female Athlete Women Health Oral Contraceptive Pill Muscle Strenght Hormones Periodized Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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N-PF (Natural Cycle - Follicular Phase-Intensified Training)

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.

Group Type EXPERIMENTAL

Resistance periodized training program (N-PF)

Intervention Type 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.

N-PL (Natural Cycle - Luteal Phase-Intensified Training)

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.

Group Type EXPERIMENTAL

Resistance peioridized training program (N-PL)

Intervention Type 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.

N-C (Natural Cycle - Continuous Training)

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.

Group Type EXPERIMENTAL

Continuous resistance training program (C)

Intervention Type 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.

OCP-C (Oral Contraceptive - Continuous Training, Control Group)

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.

Group Type ACTIVE_COMPARATOR

Continuous resistance training program (C)

Intervention Type 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.

Interventions

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Resistance periodized training program (N-PF)

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.

Intervention Type OTHER

Resistance peioridized training program (N-PL)

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.

Intervention Type OTHER

Continuous resistance training program (C)

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Physio Formation

UNKNOWN

Sponsor Role collaborator

Universite de La Reunion

OTHER

Sponsor Role lead

Responsible Party

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Manon DAUVERGNE

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas PEYROT, Professor (PU)

Role: STUDY_DIRECTOR

Université du Mans

Manon DAUVERGNE, Professor (Assistant)

Role: STUDY_DIRECTOR

Universite de La Reunion

Locations

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Laboratoire IRISSE (Université de La Réunion)

Le Tampon, France, Reunion

Site Status RECRUITING

Countries

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Reunion

Central Contacts

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Manon DAUVERGNE, PhD student

Role: CONTACT

+262693463288

Josué GAN, Msc.

Role: CONTACT

+33680306613

Facility Contacts

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Manon DAUVERGNE, PhD

Role: primary

+262693463288

Other Identifiers

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AU1941 - 24.00913.000257

Identifier Type: OTHER

Identifier Source: secondary_id

ULaReunion

Identifier Type: -

Identifier Source: org_study_id

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