Menstrual Cycle-Synced Neuromuscular Training

Part of paid clinical trials in Frisco, Texas.

Sponsor
Sophia Ulman
Study ID
NCT06983184
Status
Enrolling By Invitation

Conditions

  • ACL Injuries

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 19 Years
Healthy Volunteers
Accepted

Interventions

  • MC-synced NTP — OTHER
    Menstrual cycle-synced neuromuscular training program
  • Blinded NTP — OTHER
    Blinded neuromuscular training program

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Feb 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
212 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: MC-Synced NTP
    Menstrual cycle-synced neuromuscular training program
  • Active Comparator: Blinded NTP
    Blinded neuromuscular training program

Primary Outcome Measure

Attendance Rate [ Time Frame: From beginning to end of 8-week training program ]

Locations (1)

FacilityCityStateZIPSite coordinators
Scottish Rite for ChildrenFriscoTexas75034-

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Scottish Rite for Children· Frisco, TX

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