Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT06844968
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2025-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a 2000-m Ergometer Test on Training Status Indicators and the Muscle Adaptation in Rowers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005082', 'term': 'Physical Exertion'}], 'ancestors': [{'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A group of rowers subjected to an efford on a rowing ergometer. The examined rowers group will be subjected to an effort on a rowing ergometer, consisting of covering a designated distance in the shortest possible time.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EPO (erythropoietin) level', 'timeFrame': 'Immediately before the ergometer test, immediately after and 3 hours after the test', 'description': 'Immunoenzymatic assay method using a diagnostic ELISA Kit'}, {'measure': 'VEGF (vascular endothelial growth factor) level', 'timeFrame': 'Immediately before the ergometer test, immediately after and 3 hours after the test', 'description': 'Immunoenzymatic assay method using a diagnostic ELISA Kit'}, {'measure': 'Hypoxanthine (Hx) level', 'timeFrame': 'Immediately before the ergometer test, immediately after and 3 hours after the test', 'description': 'Immunoenzymatic assay method using a diagnostic ELISA Kit'}, {'measure': 'Glycogen level', 'timeFrame': 'Immediately before the ergometer test, immediately after and 3 hours after the test', 'description': 'Immunoenzymatic assay method using a diagnostic ELISA Kit'}, {'measure': 'Glucose level', 'timeFrame': 'Immediately before the ergometer test, immediately after and 3 hours after the test', 'description': 'Using an Accu-Chek Active glucometer (Roche, Germany)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rowers', 'EPO', 'VEGF', 'hypoxanthine', 'glycogen', 'athletes'], 'conditions': ['Exhaustion - Physiological']}, 'descriptionModule': {'briefSummary': "Intense physical exercise can lead to micro-damage to tissues and activation of inflammatory processes, the body's natural response to exercise-related metabolic stress. Monitoring inflammation and fatigue will enable the observation of athletes in terms of post-exercise regeneration and muscle adaptation to physical effort. The obtained results will allow for estimating the level of fatigue, minimizing the risk of injury, and will show the rate of post-exercise regeneration or its absence.", 'detailedDescription': "The study will involve 40 members of the Polish Youth Rowing Team, both sexes, aged 19-23. The study will be held on three dates related to the specifics of the athletes' training cycle, i.e. in the preparatory period (March), the competition period (June), and the detraining period (November). The participants will perform an intensive exercise test on a rowing ergometer (manufacturer: Concept II, USA), covering a distance of 2,000 meters in the shortest possible time. The study will involve 40 members of the Polish Youth Rowing Team, both sexes, aged 19-23. Each time, before starting the exercise test, a non-invasive anthropometric analysis will be performed using the TANITA MC-780MA body composition analyzer (tanita Japan), to determine the body composition: percentage of body fat, body fat mass, lean tissue mass, muscle mass, body water and body mass index (BMI). On the three indicated dates, before and after the stress test, capillary blood (ear lobe) from the cubital vein will be collected from the participants. Using immunoenzymatic ELISA tests, the following will be determined: EPO (erythropoietin), VEGF (vascular endothelial growth factor), CRP (C-reactive protein), glycogen, hypoxanthine (Hx). Glucose level will be determined using an Accu-Chek Active glucometer (Roche, Germany)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '23 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* members of the Polish Youth Rowing Team - competitors officially called up to the Polish national rowing team,\n* no musculoskeletal injuries that would prevent them from performing the exercise test,\n* written consent of the competitor to participate in the study.\n\nExclusion Criteria:\n\n* anti-inflammatory drugs, other supplements in the last 3 months before starting the study,\n* failure to complete the test,\n* current injury, post-traumatic condition, illness,\n* lack of informed consent of the athlete.'}, 'identificationModule': {'nctId': 'NCT06844968', 'acronym': 'ETTETTSIAMAR', 'briefTitle': 'The Effect of a 2000-m Ergometer Test on Training Status Indicators and the Muscle Adaptation in Rowers', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': 'Multi-Faced Optimization of Sports Training Focused on Training Status Energy and Muscle Adaptation to Effort', 'orgStudyIdInfo': {'id': 'Rowers 2024'}, 'secondaryIdInfos': [{'id': 'RPW/8857/2024', 'type': 'OTHER', 'domain': 'Ministry of Sport and Tourism'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Physical effort', 'description': 'The effort on the rowing ergometer, based on swimming a specified distance in the shortest possible time.', 'interventionNames': ['Other: Physical effort']}], 'interventions': [{'name': 'Physical effort', 'type': 'OTHER', 'otherNames': ['Rowing ergometer test'], 'description': 'The examined rowers will be subjected to an effort on a rowing ergometer, consisting of covering a designated distance in the shortest possible time.', 'armGroupLabels': ['Physical effort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66-400', 'city': 'Gorzów Wielkopolski', 'state': 'Polska', 'country': 'Poland', 'facility': 'Poznań University of Physical Education, Faculty of Physical Culture in Gorzów Wielkopolski', 'geoPoint': {'lat': 52.73371, 'lon': 15.22505}}], 'overallOfficials': [{'name': 'Anna Kasperska, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poznań University of Physical Education, Faculty of Sport Sciences in Gorzów Wielkopolski, Poland;'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}