Scottish Rite for Children
Frisco, Texas, 75034, United States
NCT Number: NCT06983184
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.
Interested in participating?
Request Info13 year–19 year
Female
Interventional
Not applicable
Frisco, Texas, 75034, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be excluded from enrollment if they:
Menstrual cycle-synced neuromuscular training program
Blinded neuromuscular training program
Time frame: From beginning to end of 8-week training program
Rate of attendance at training program
Time frame: From beginning to end of 8-week training program
Level of engagement throughout participation in training program as rated by the study team on a scale of "Very Dissatisfied" to "Very Satisfied".
Time frame: From beginning to end of 8-week training program
Participant feedback on training program through a 3-question participant questionnaire.
Time frame: From beginning to end of 8-week training program
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).
Time frame: 6 months, 1 year and 2 years post-training
Patient reported outcome questionnaire on self-perceptions about being an athlete
Time frame: 6 months, 1 year and 2 years post-training
Patient reported outcome measure on athlete nutritional habits
Time frame: 6 months, 1 year and 2 years post-training
Patient reported outcome measure on sleep habits
Sophia Ulman
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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