Menstrual Cycle-Synced Neuromuscular Training

NCT06983184 | Enrolling By Invitation DMC

• 1 other identifier: STU20250837
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study of female athletes participating in at least one running/cutting sport, who have no current conditions that would limit ability to perform sport-like movement tasks (such as running or jumping), and have reported to be post-menarche (a regular period). The purpose of this study is to leverage the menstrual cycle (MC) to improve the success of a neuromuscular training program (NTP) that has been shown to reduce high-risk movement patterns in adolescent females. The findings of this study may not only help develop more effective, personalized injury prevention strategies for female athletes, but may also have the potential to reduce ACL injury rates while improving long-term physical activity and health for active females. The researchers hope that this information may help reduce ACL injury rates and enhance long-term musculoskeletal health in female athletes, while promoting greater equity in sports medicine and performance training. Participants will be asked to wear an Oura Ring (a ring that is placed on a finger of the non-dominant hand) that will be used to track their menstrual cycle phases. The Oura Ring will be connected using a software called "Natural Cycles", which will sync to either a smart phone via Bluetooth, or data from the device can be downloaded to an iPad utilized by the research team. Participants will also take part in an 8-week Neuromuscular Training Program (NTP), that consists of two 30-minute training sessions per week, which will include dynamic exercises designed to improve strength and power, balance, and stability, as well as help to build a foundation of muscular endurance. Before starting the training program, participants will be asked to complete several questionnaires focused on activity level, sport participation characteristics, sport-related injury history, and menstrual cycle history, and both before and after completing the training program, participant movement patterns may be evaluated. For the training program, participants will be randomized into one of two groups - one that syncs the training type to the participant's menstrual cycle and one that does not. All participants will receive the same exercises, however, a participant's assigned group will determine when they receive certain exercises. Participation in this study is completely voluntary. Participation is expected to last up to 7 months. This is a minimal risk research study. There is a small risk of falling during movement tasks, skin irritation from tape that is used during movement evaluation, psychological stress from survey questions, and loss of confidentiality. To minimize these risks, participants may request rest breaks or stop participating at any time. Participants may also refuse to answer any questions that are asked, and all information collected from this research will be stored in a secure electronic database. This information known as "data" will not be shared with any person outside of the study team. There is no benefit to participants who participate in this research study. However, the investigators hope the information gathered from this research may benefit others in the future.

Conditions

ACL Injuries

Keywords

ACL; menstruation; Neuromuscular training; female athlete

Outcome Measures

Primary Outcomes (4)

• Attendance Rate

  Rate of attendance at training program

  From beginning to end of 8-week training program

• Engagement Rate

  Level of engagement throughout participation in training program as rated by the study team on a scale of "Very Dissatisfied" to "Very Satisfied".

  From beginning to end of 8-week training program

• Participant feedback survey

  Participant feedback on training program through a 3-question participant questionnaire.

  From beginning to end of 8-week training program

• Biomechanical risk factors associated with ACL injury during dynamic, sport-related tasks

  Changes in biomechanical risk factors associated with ACL injury during dynamic, sport-related tasks as evaluated through changes in motion capture analysis of six dynamic, sport-like tasks (step down tap, drop vertical jump, single leg hop, lateral shuffle, deceleration / plant, run-cut / change-of-direction).

  From beginning to end of 8-week training program

Study Arms (2)

MC-Synced NTP

EXPERIMENTAL

Menstrual cycle-synced neuromuscular training program

Other: MC-synced NTP

Blinded NTP

ACTIVE COMPARATOR

Blinded neuromuscular training program

Other: Blinded NTP

Interventions

Blinded NTP OTHER

Blinded neuromuscular training program

Blinded NTP

MC-synced NTP OTHER

Menstrual cycle-synced neuromuscular training program

MC-Synced NTP

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy, female high school athlete who participate in running/pivoting sports (e.g., soccer and basketball)
• Aged 14-19 years
• Participants must also have a mobile phone, personally or via a parent, capable of downloading the Oura Ring app and of syncing to a wearable device via Bluetooth.
• Participants will not be excluded from participation if they report irregular periods (not a typical 28-day cycle) or use of hormonal birth control.

You may not qualify if:

• Participants will be excluded from enrollment if they:
• Have been diagnosed with any musculoskeletal or neuromuscular condition that would impact their movement patterns or training performance
• Report not yet starting their menses or not currently menstruating (no period in the prior 3 months).
• Females in the general student body who are not an active participant of the school's soccer or basketball program will be excluded from the study.
• Participants will be withdrawn if they become pregnant during the course of the study.

Sponsors & Collaborators

• Sophia Ulman: lead
• Texas Scottish Rite Hospital for Children: collaborator

Study Sites (1)

Scottish Rite for Children

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 21, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)