148 Participants Needed

Menstrual Cycle-Synced Training for ACL Injury

Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: Sophia Ulman
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for female athletes who participate in running/cutting sports, have regular menstrual cycles, and no current limitations to sport-like movements. They must be post-menarche with no conditions affecting their ability to perform tasks like running or jumping.

Inclusion Criteria

My menstrual cycle is irregular or I use hormonal birth control, but I can still participate.
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
I am between 13 and 19 years old.
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Exclusion Criteria

Report not yet starting their menses or not currently menstruating (no period in the prior 3 months)
I am not part of my school's soccer or basketball teams.
Participants will be withdrawn if they become pregnant during the course of the study
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neuromuscular Training Program

Participants take part in an 8-week Neuromuscular Training Program (NTP) with two 30-minute training sessions per week, including dynamic exercises to improve strength, power, balance, and stability.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after the training program, including evaluation of movement patterns.

4 weeks

Treatment Details

Interventions

  • Blinded NTP
  • MC-synced NTP
Trial Overview The study tests if syncing neuromuscular training programs (NTP) with the menstrual cycle can reduce risky movement patterns and ACL injuries. Participants will wear an Oura Ring to track their cycle and do NTP twice a week for 8 weeks, with some receiving MC-synced exercises.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: MC-Synced NTPExperimental Treatment1 Intervention
Menstrual cycle-synced neuromuscular training program
Group II: Blinded NTPActive Control1 Intervention
Blinded neuromuscular training program

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sophia Ulman

Lead Sponsor

Texas Scottish Rite Hospital for Children

Collaborator

Trials
23
Recruited
9,000+
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