Clinical trial NCT06679491: Impact of Menstrual Cycle-Based Resistance Training on Neuromuscular Performance in Female Athletes
Official title: Effects of Menstrual Cycle-based Undulating Periodized Resistance Training in Women's Neuromuscular Abilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menstrual Cycle
Resistance Training
Neuromuscular Function
Female Athlete
Women Health
Oral Contraceptive Pill
Muscle Strenght
Hormones
Periodized Training
Keywords: Menstrual Cycle
Resistance training
Periodized training
neuromuscular function
Female athlete
Hormones
oral contraceptive pill
women health
Lead sponsor: Universite de La Reunion
Sponsor class: OTHER
Collaborators: name: Physio Formation
First posted: 2024-11-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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 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: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Maximal knee extensor strenght
timeFrame: From baseline assessment prior to intervention to post-intervention at 13 weeks.
Secondary outcomes:
measure: Rate of Force Development (RFD)
timeFrame: From baseline assessment prior to intervention to post-intervention at 13 weeks
measure: Active muscle stiffness
timeFrame: From baseline assessment prior to intervention to post-intervention at 13 weeks.
measure: Voluntary Muscle Activation (%AV)
timeFrame: From baseline assessment prior to intervention to post-intervention at 13 weeks.
measure: Vertical Jump Height (Countermovement Jump - CMJ)
timeFrame: From baseline assessment prior to intervention to post-intervention at 13 weeks.
Other outcomes:
Locations:
city: Le Tampon
country: Réunion
facility: Laboratoire IRISSE (Université de La Réunion)
state: France
Study officials:
affiliation: Université du Mans
name: Nicolas PEYROT, Professor (PU)
role: STUDY_DIRECTOR
affiliation: Universite de La Reunion
name: Manon DAUVERGNE, Professor (Assistant)
role: STUDY_DIRECTOR
References: