NCT06679491

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Nov 2024Dec 2027

Study Start

First participant enrolled

November 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 5, 2024

Last Update Submit

November 5, 2024

Conditions

Keywords

Menstrual CycleResistance trainingPeriodized trainingneuromuscular functionFemale athleteHormonesoral contraceptive pillwomen health

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

  • Rate of Force Development (RFD)

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

  • Active muscle stiffness

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

  • Voluntary Muscle Activation (%AV)

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

  • Vertical Jump Height (Countermovement Jump - CMJ)

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

Study Arms (4)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

N-C (Natural Cycle - Continuous Training)

EXPERIMENTAL

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)

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

ACTIVE COMPARATOR

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)

Interventions

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

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

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.

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire IRISSE (Université de La Réunion)

Le Tampon, France, 97430, Reunion

RECRUITING

Study Officials

  • Nicolas PEYROT, Professor (PU)

    Université du Mans

    STUDY DIRECTOR
  • Manon DAUVERGNE, Professor (Assistant)

    Universite de La Reunion

    STUDY DIRECTOR

Central Study Contacts

Manon DAUVERGNE, PhD student

CONTACT

Josué GAN, Msc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 7, 2024

Study Start

November 1, 2024

Primary Completion

July 1, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations