[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06983184":3,"trial-entities:NCT06983184":98,"trial-summary:NCT06983184":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":55,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":14,"eligibility_criteria":69,"std_ages":81,"locations":84,"central_contacts":94,"overall_officials":95,"references":96,"see_also_links":97},"NCT06983184","STU20250837","Menstrual Cycle-Synced Neuromuscular Training","ENROLLING_BY_INVITATION","2027-05-01","2026-06","2026-07-01","2025-05-01","Sophia Ulman","OTHER",true,"This is a research study of female athletes participating in at least one running\u002Fcutting 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).\n\nThe 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.\n\nThe 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.\n\nParticipants 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.\n\nParticipation in this study is completely voluntary. Participation is expected to last up to 7 months.\n\nThis 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.\n\nThere 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.",null,[18],"ACL Injuries",[20,21,22,23],"ACL","menstruation","Neuromuscular training","female athlete","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},148,"ESTIMATED",[32,37],{"type":13,"name":33,"description":34,"armGroupLabels":35},"MC-synced NTP","Menstrual cycle-synced neuromuscular training program",[36],"MC-Synced NTP",{"type":13,"name":38,"description":39,"armGroupLabels":40},"Blinded NTP","Blinded neuromuscular training program",[38],[42,46,49,52],{"measure":43,"description":44,"timeFrame":45},"Attendance Rate","Rate of attendance at training program","From beginning to end of 8-week training program",{"measure":47,"description":48,"timeFrame":45},"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\".",{"measure":50,"description":51,"timeFrame":45},"Participant feedback survey","Participant feedback on training program through a 3-question participant questionnaire.",{"measure":53,"description":54,"timeFrame":45},"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 \u002F plant, run-cut \u002F change-of-direction).",[56,60,63],{"measure":57,"description":58,"timeFrame":59},"AIMS Questionnaire","Patient reported outcome questionnaire on self-perceptions about being an athlete","6 months, 1 year and 2 years post-training",{"measure":61,"description":62,"timeFrame":59},"SNAC Nutrition Survey","Patient reported outcome measure on athlete nutritional habits",{"measure":64,"description":65,"timeFrame":59},"PSQI Sleep Survey","Patient reported outcome measure on sleep habits","FEMALE","13 Years","19 Years",{"inclusion":70,"exclusion":75,"raw_text":80},[71,72,73,74],"Healthy, female high school athlete who participate in running\u002Fpivoting sports (e.g., soccer and basketball)","Aged 13-19 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.",[76,77,78,79],"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.","Inclusion Criteria:\n\n* Healthy, female high school athlete who participate in running\u002Fpivoting sports (e.g., soccer and basketball)\n* Aged 13-19 years\n* 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.\n* Participants will not be excluded from participation if they report irregular periods (not a typical 28-day cycle) or use of hormonal birth control.\n\nExclusion Criteria:\n\nParticipants will be excluded from enrollment if they:\n\n* Have been diagnosed with any musculoskeletal or neuromuscular condition that would impact their movement patterns or training performance\n* Report not yet starting their menses or not currently menstruating (no period in the prior 3 months).\n* 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.\n* Participants will be withdrawn if they become pregnant during the course of the study.",[82,83],"CHILD","ADULT",[85],{"facility":86,"city":87,"state":88,"zip":89,"country":90,"geoPoint":91},"Scottish Rite for Children","Frisco","Texas","75034","United States",{"lat":92,"lon":93},33.15067,-96.82361,[],[],[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[100],"Injury of anterior cruciate ligament",[],{"nct_id":4,"found":14,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study comparing two different neuromuscular training programs. It plans to enroll 148 female participants.","completed","Menstrual Cycle-Synced Neuromuscular Training for ACL Injury Prevention","This study is looking at how a special exercise program, called Menstrual Cycle-synced Neuromuscular Training Program (MC-synced NTP), can help prevent ACL (anterior cruciate ligament) injuries in young female athletes. It compares this program to a standard, or 'Blinded NTP,' to see if timing exercises with a girl's menstrual cycle makes the training more effective. You might be able to join if you are a healthy female high school athlete, aged 13-19, who plays running or pivoting sports like soccer or basketball, and has regular periods. The study aims to enroll 148 participants and will measure success by how well participants attend and engage with the program, and their feedback. The current recruitment status is unclear.","The primary endpoints are measured from the beginning to the end of the 8-week training program.",116,"You would participate in an 8-week training program and complete participant feedback surveys. You would also need a mobile phone capable of syncing with a wearable device.","Not stated in the trial record.",[33,38],"v2"]