Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 7:29 PM
Study NCT ID:
NCT06451367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular and Endocrine Response to Muscular Training Program of Young Soccer Players Aged 14-18 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to either a control group or an intervention group (N=30, with 15 participants in each group). This study focuses on football players aged 14 to 18 who are part of the elite team of the football society of Fribourg, Switzerland.\n\nIn the control group, participants engage exclusively in regular football training, whereas participants in the intervention group also participate in a 12-week neuromuscular development program.\n\nMeasurements\n\nBefore and after the intervention, various measurements are taken for each participant, including:\n\nBlood steroid profile Heart rate variability Lung function using ergospirometry (VO2 max with lactate) Body composition using the Inbody 770 machine Muscular strength using a Newton measurement'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VO2 max, lactate', 'timeFrame': 'Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).', 'description': 'The study aims to examine the effects of a 12-week supplemental muscle program on cardiopulmonary exercise testing, focusing on key metrics such as maximum oxygen uptake (VO2max in mL/kg/min with capillary lactate measurement in mmol/L)'}, {'measure': 'Heart rate variability', 'timeFrame': 'Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).', 'description': 'The study aims to examine the effects of a 12-week supplemental muscle program on cardiopulmonary exercise testing, focusing on key metrics such as heart rate variability (HRV in ms).'}, {'measure': 'Body composition', 'timeFrame': 'Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).', 'description': 'The study aims to examine the effects of a 12-week supplemental muscle program on cardiopulmonary exercise testing, focusing on key metrics such as body composition (percentage of body fat, muscle mass in kg). Height will be measured in centimeters (cm) and weight in kilograms (kg) to calculate the Body Mass Index (BMI) in kg/m²'}], 'secondaryOutcomes': [{'measure': 'Hormonal changes: Cortisol', 'timeFrame': 'Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).', 'description': 'The study includes a secondary endpoint involving the measurement of cortisol levels (in μg/dL) before and after the muscular training program. These measurements offer valuable insights into the endocrine adaptations induced by the training regimen. By analyzing changes in cortisol levels, researchers can gain a deeper understanding of the hormonal milieu associated with muscle development, recovery, and overall physiological balance.'}, {'measure': 'Hormonal changes: Testosterone', 'timeFrame': 'Before the start of the 12-week muscular training program (pre-intervention) and immediately after the 12-week intervention (post-intervention).', 'description': 'The study includes a secondary endpoint involving the measurement of testosterone levels (in ng/dL) before and after the muscular training program. These measurements offer valuable insights into the endocrine adaptations induced by the training regimen. By analyzing changes in testosterone levels, researchers can gain a deeper understanding of the hormonal milieu associated with muscle development, recovery, and overall physiological balance.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sport Injury', 'Hormone Disturbance', 'Cardiovascular Abnormalities']}, 'descriptionModule': {'briefSummary': "This study focuses on understanding the cardiovascular and endocrine responses of young soccer players aged 14 to 18 years to a muscular training program. Adolescence is a critical period for physiological development, and investigating these responses can provide insights crucial for athletic performance and overall health. The benefits include promoting overall health, reducing injury risk, and enhancing scientific knowledge. However, intensive training programs may lead to overtraining and potential negative health outcomes if not carefully monitored. The study aims to assess whether additional neuromuscular development over 12 weeks can enhance players' physical fitness and hormonal changes. By examining these outcomes, the study seeks to inform evidence-based training protocols for optimizing adolescent athletes' health and performance in soccer. The study design involves a prospective single-center randomized cohort to investigate these responses comprehensively.", 'detailedDescription': 'In this study, participants aged 14 to 18, who are part of an elite football team in Fribourg, Switzerland, are randomly assigned to either a control group or an intervention group (N=30, with 15 participants in each group). The control group undergoes regular football training, while the intervention group additionally participates in a 12-week neuromuscular development program. Before and after the intervention, various measurements are taken for each participant, including blood steroid profile, heart rate variability, lung function (VO2 max with lactate), body composition using the Inbody 770 machine, and muscular strength. The control group exclusively engages in regular football training throughout the study duration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Engaging in a football training program.\n* No history of injuries in the last 6 months requiring surgical intervention.\n* No intake of anabolic supplements.\n* Age 14-18 years old.\n* Normal BMI (18.5 - 24.9 kg/m²).\n\nParents and participants must consent to receive all pertinent information discovered during the study, such as potential cardiovascular diseases or hormonal disorders.\n\nParticipants must also consent to the sharing of certain private information with their parents or legal guardians. This includes information regarding cannabis use, as well as the consumption of anabolic steroids and other controlled substances. This additional consent ensures transparency and openness in sharing relevant health-related information with parents or legal guardians, particularly for participants under 18 years of age.\n\nFor participants under the age of 18, parental consent or consent from a legal guardian is mandatory in addition to the participant's consent. This ensures that minors have parental approval to take part in the study.\n\nAll participants, regardless of age, must provide their voluntary consent to participate in the study. For participants under the age of 18, consent from one of their parents or legal guardians is also required in addition to the participant's consent.\n\nExclusion Criteria:\n\n* Engaging in other supplemental individual exercise programs.\n* Being a smoker (\\>1 cigarette/week).\n* Using any medication at the time of testing.\n* Having any disease."}, 'identificationModule': {'nctId': 'NCT06451367', 'acronym': 'YoungSoccer', 'briefTitle': 'Cardiovascular and Endocrine Response to Muscular Training Program of Young Soccer Players Aged 14-18 Years', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Fribourgeois'}, 'officialTitle': 'Cardiovascular and Endocrine Response to Muscular Training Program of Young Soccer Players Aged 14-18 Years', 'orgStudyIdInfo': {'id': 'YoungSoccer_14-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Regular football training and neuromuscular training program for 12 weeks', 'interventionNames': ['Other: neuromuscular programm']}, {'type': 'NO_INTERVENTION', 'label': 'Controle', 'description': 'Regular football training'}], 'interventions': [{'name': 'neuromuscular programm', 'type': 'OTHER', 'description': 'neuromuscular programm during 12 weeks (3 times a week, 10 minutes each time)', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maristella Santi, Dr. med', 'role': 'CONTACT', 'email': 'maristella.santi@h-fr.ch', 'phone': '079 720 95 20'}, {'name': 'Johannes Wildhaber-Brooks, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'maristella.santi@h-fr.ch', 'phone': '026 306 00 00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Fribourgeois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}