Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-04-04 @ 5:51 AM
Study NCT ID:
NCT06906666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Injury Risk Factors in Elite Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001265', 'term': 'Athletic Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measurement of the body mass index', 'timeFrame': 'Screening visit', 'description': 'The measurement of the body mass index (measured in kg/m2) will be a possible confounding variable.'}, {'measure': 'Measurement of the date of tendon injuries', 'timeFrame': 'Screening visit', 'description': 'The date of tendon injuries in that period will be a possible confounding variable.'}, {'measure': 'Measurement of federated time', 'timeFrame': 'Screening visit', 'description': 'The evaluation of federated time (measured in completed months) will be a possible confounding variable.'}], 'primaryOutcomes': [{'measure': 'Measurement of number of lower limb tendon injuries', 'timeFrame': 'Screening visit', 'description': 'The primary variable will be the number of lower limb tendon injuries in the last three seasons'}], 'secondaryOutcomes': [{'measure': 'Measurement of age', 'timeFrame': 'Screening visit', 'description': 'The measurement of age (measured in completed years) will be a secondary variable.'}, {'measure': 'Measurement of the weekly training load', 'timeFrame': 'Screening visit', 'description': 'The measurement of the weekly training load (measured in minutes) will be a secondary variable.'}, {'measure': 'Measurement of the type of footwear', 'timeFrame': 'Screening visit', 'description': 'The evaluation of the type of footwear (with the response options: shoe without carbon plate, shoe with carbon plate, spike shoe without carbon plate and spike shoe with carbon plate) will be a secondary variable.'}, {'measure': 'Measurement of the type of diet', 'timeFrame': 'Screening visit', 'description': 'The evaluation of the type of diet (with the response options: balanced, rich in carbohydrates, rich in proteins and adapted to the training cycle) will be a secondary variable.'}, {'measure': 'Measurement of the practice of another physical activity', 'timeFrame': 'Screening visit', 'description': 'The evaluation of the practice of another physical activity on a regular basis will be a secondary variable.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscle Injury', 'Athletics', 'Risk', 'Secondary Prevention', 'Physiotherapy'], 'conditions': ['Athletic Injuries']}, 'descriptionModule': {'briefSummary': 'Background information. The different disciplines of athletics place high physical demands on athletes. These different categories of running vary in terms of physical effort and duration, generating different levels of risk of injury. The description of the main injuries that affect elite athletes in the different athletics disciplines, as well as the identification of the specific risk factors of each discipline, will allow the identification of preventive measures to be implemented.\n\nObjective. To identify the risk factors for tendon injury in professional long- and middle-distance athletes, according to the type of event, and to identify the best predictive model for tendon injuries based on anthropometric and athletic variables.\n\nMethod. Ambispective cohort study. 81 elite athletes will be recruited. The primary variable will be the number of tendon injuries in the last three seasons. The secondary and modifying variables will be: age (in completed years), weekly training load (in minutes), type of footwear (sneakers without carbon plate, sneakers with carbon plate, spiked sneakers without carbon plate and spiked sneakers with carbon plate), diet (balanced, high in carbohydrates, high-protein, controlled hypocaloric and adapted to the training cycle) and the regular practice of another physical activity. The possible confounding variables will be the body mass index, the date of tendon injuries in that period and the time spent as a federated athlete (in completed months). The analysis will calculate the risk of injury in these athletes and assess the influence of confounding factors and trend analysis on the primary variable, stratified by possible confounding factors.\n\nExpected results. To calculate the risk of injury in elite athletes based on anthropometric and sociodemographic variables. To identify the predictive model of tendon injuries in elite athletes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elite athletes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elite federated athletes\n* Who have not undergone previous musculoskeletal surgery in the seasons under study\n* Who were federated at least one year before the study period\n* Sign the informed consent document.\n\nExclusion Criteria:\n\n* Athletes who have not participated in competition, during the study seasons, for a period of more than 6 months due to a musculoskeletal injury'}, 'identificationModule': {'nctId': 'NCT06906666', 'briefTitle': 'Analysis of Injury Risk Factors in Elite Athletes', 'organization': {'class': 'OTHER', 'fullName': 'University of Oviedo'}, 'officialTitle': 'Analysis of Injury Risk Factors in Elite Athletes. A Cross-sectional Cohort Study.', 'orgStudyIdInfo': {'id': 'ATL-risk'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observacional group', 'interventionNames': ['Other: Athletes sample']}], 'interventions': [{'name': 'Athletes sample', 'type': 'OTHER', 'otherNames': ['Elite athletes group'], 'description': 'Elite athletes in whom the risk of injury will be calculated and the influence of confounding factors will be assessed through a personal interview.', 'armGroupLabels': ['Observacional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'University of Oviedo', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}], 'centralContacts': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'CONTACT', 'email': 'cuestaruben@uniovi.es', 'phone': '607547274'}], 'overallOfficials': [{'name': 'Rubén Cuesta-Barriuso', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Oviedo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oviedo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ruben Cuesta Barriuso', 'investigatorAffiliation': 'University of Oviedo'}}}}