Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT07264751
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2025-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a Single Training Session on Changes in Inflammatory, Hormonal, and Metabolic Markers in Athletes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-11-23', 'studyFirstSubmitQcDate': '2025-11-23', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'UA', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'Uric acid'}], 'primaryOutcomes': [{'measure': 'hsCRP', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'highly sensitive reactive C-protein'}, {'measure': 'CK', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'creatine kinase'}, {'measure': 'TNF-alpha', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'tumor necrosis factor alpha'}, {'measure': 'IL-6', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'Interleukine-6'}, {'measure': 'A', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'Adrenaline'}, {'measure': 'Noradrenaline', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'Noradrenaline'}], 'secondaryOutcomes': [{'measure': 'Kortisol', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'Noradrenaline'}, {'measure': 'TP', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'total protein'}, {'measure': 'Urea', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'Urea'}, {'measure': 'Albumin', 'timeFrame': '1. Before training (at rest), 2. Immediately after training, 3. 24 hours after exercise.', 'description': 'Albumin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wrestlers', 'catecholamines', 'Single training session', 'Inflammatory markers', 'Hormonal response'], 'conditions': ['Training', 'Inflammation Biomarkers', 'Hormone', 'Exercise Training']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the acute response of wrestlers to a single training session. Short-term changes in inflammatory, hormonal, and metabolic markers will be analyzed, which may reflect the development of fatigue and recovery processes following intense exercise. Participation in the study involves performing a standard training session and collecting blood samples at three time points to assess the physiological response. The results will provide a better understanding of the mechanisms of adaptation to exercise in strength and endurance athletes.', 'detailedDescription': "The study aims to assess how wrestlers' bodies respond to a single, intense training session. The study focuses on short-term changes in markers of inflammation, the hormonal system (stress hormones, catecholamines), and the metabolic system. This enables a deeper understanding of the physiological mechanisms underlying fatigue development and post-exercise recovery.\n\nEach participant will attend one standard training session, as outlined in the training plan. As part of the study, three venous blood samples will be collected:\n\n* Before training - at rest, to determine baseline values;\n* Immediately after training;\n* 24 hours after exercise - to evaluate recovery processes.\n\nBlood samples will be analyzed in the lab to determine:\n\n* inflammatory markers (hsCRP, IL-6, TNF-α),\n* muscle damage marker (CK),\n* stress hormones (adrenaline, noradrenaline, cortisol),\n* metabolic indicators (urea, creatinine, total protein, albumin, uric acid). The project does not require any additional supplementation, dietary changes, or modifications to the training plan.\n\nParticipating in the study will provide insights into your individual body's response to intense exercise, including fatigue levels, inflammation, and hormonal balance. The results can help you better tailor your training load and improve your recovery.\n\nParticipation in the study is completely voluntary. Participants may withdraw from participation at any time, without giving a reason, without any consequences. Withdrawal from the study will not affect their subsequent athletic training. All data obtained during the study will be treated confidentially and processed solely for scientific purposes. Results will be compiled in aggregate form, preventing the identification of individual participants.\n\nThe study protocol was approved by the bioethics committee."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study participants are elite wrestlers who are also members of a national-level sports club and members of the national team. All athletes have experience competing in international events. The group includes athletes who have won medals at both national and international competitions. Participants are highly trained, with extensive experience in strength-endurance wrestling disciplines, and represent the top competitive level in their sport. The study aims to evaluate acute physiological responses to a single high-intensity training session in this highly specialized discipline.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently engaged in regular strength-endurance wrestling training.\n* Medically cleared for high-intensity exercise by a sports physician.\n* Willingness to participate and provide written informed consent.\n* Availability to attend the training session and all blood sampling time points (pre-training, immediately post-training, 24 hours post-training)\n\nExclusion Criteria:\n\n* Presence of acute or chronic illness that may affect exercise performance or physiological response\n* Recent musculoskeletal injury limiting participation in high-intensity training.\n* Use of medications or supplements that may interfere with hormonal, inflammatory, or metabolic markers\n* History of endocrine disorders, adrenal insufficiency, or other conditions affecting catecholamine or cortisol levels\n* Inability or unwillingness to comply with study procedures.'}, 'identificationModule': {'nctId': 'NCT07264751', 'briefTitle': 'The Effect of a Single Training Session on Changes in Inflammatory, Hormonal, and Metabolic Markers in Athletes.', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': 'The Effect of a Single Training Session on Changes in Inflammatory, Hormonal, and Metabolic Markers in Athletes.', 'orgStudyIdInfo': {'id': 'AKS wrestlers'}}, 'armsInterventionsModule': {'interventions': [{'name': 'physical training', 'type': 'BEHAVIORAL', 'description': 'The intervention consists of a standardized, high-intensity wrestling training session designed to simulate typical strength-endurance exercise performed by elite wrestlers. The session includes sport-specific drills, resistance exercises, and aerobic conditioning components appropriate for this athletic discipline. All participants will perform the session under supervision to ensure safety and adherence to the planned intensity and duration.'}]}, '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', 'description': 'IPD will not be shared to protect participant confidentiality and to meet ethical and legal standards regarding sensitive health and performance data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Kasperska', 'investigatorAffiliation': 'Poznan University of Physical Education'}}}}