Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT06246760
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2024-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differences in Ventilatory Function, Body Composition, and Cardiorrespiratory Fitness According to Training Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1272}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Training status', 'timeFrame': 'breath-by-breath during the whole test', 'description': 'Oxygen uptake at ventilatory threshold 1, ventilatory threshold 2 and maximal oxygen uptake'}, {'measure': 'Body composition', 'timeFrame': 'one determination before the test', 'description': 'Fat mass (kg), fat free mass (kg), fat mass percentage, fat-free mass (FFM) percentage, weight (kg), and height (m). These variables are assesed by dual-energy X-ray absorptiometry (DXA).'}, {'measure': 'Bone mineral density', 'timeFrame': 'one determination before the test', 'description': 'Total, lumbar spine and femoral neck bone mineral density (g/cm\\^2). These variables are assesed by dual-energy X-ray absorptiometry (DXA).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Composition', 'Cardiovascular Health', 'Ventilatory Physiology']}, 'referencesModule': {'references': [{'pmid': '40528561', 'type': 'DERIVED', 'citation': 'Benitez-Munoz JA, Alcocer-Ayuga M, Cupeiro R, Guisado-Cuadrado I, Rojo-Tirado MA, Alfaro-Magallanes VM, Romero-Parra N, Aparecida-Castro E, Ramos-Campo DJ, Armero-Sotillo A, Peinado AB, Benito PJ. Ventilatory Thresholds Differences According to Aerobic Fitness Level in 1450 Males and 241 Females on Cycle-Ergometer: A Cross-Sectional Study. Eur J Sport Sci. 2025 Jul;25(7):e12323. doi: 10.1002/ejsc.12323.'}, {'pmid': '39316126', 'type': 'DERIVED', 'citation': 'Benitez-Munoz JA, Benito PJ, Guisado-Cuadrado I, Cupeiro R, Peinado AB. Differences in the ventilatory thresholds in treadmill according to training status in 971 males and 301 females: a cross-sectional study. Eur J Appl Physiol. 2025 Feb;125(2):499-510. doi: 10.1007/s00421-024-05622-z. Epub 2024 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this cross-over study is to evaluate the physiological response to exercise and body composition according to training status in participants with a wide spectrum of fitness states. The main questions it aims to answer are:\n\n* Which are the physiological differences across participants with different training status?\n* Which are the body composition differences across participants with different training status?', 'detailedDescription': 'To satisfy the objective of the project, participants will perform an incremental test until volitional exhaustion. During this test, respiratory gases will be measured via a gas analyser as well as the cardiac response via an electrocardiogram. The same participants will have their body composition measured by dual X-ray densitometry (DXA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be in enough physical fitness to perform the incremental test to volitional exhaustion.\n\nExclusion Criteria:\n\n* Present any health condition preventing to perform the incremental exercise test until volitional exhaustion.'}, 'identificationModule': {'nctId': 'NCT06246760', 'briefTitle': 'Differences in Ventilatory Function, Body Composition, and Cardiorrespiratory Fitness According to Training Status', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Politecnica de Madrid'}, 'officialTitle': 'Prestación de Servicios científicos, evaluación y Control Del Rendimiento', 'orgStudyIdInfo': {'id': 'PSC191100471'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Incremental exercise test', 'description': 'Maximal incremental exercise test on a treadmill or a cycle ergometer until volitional exhaustion', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Incremental exercise test until volitional exhaustion', 'armGroupLabels': ['Incremental exercise test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Comunity of Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Belén Peinado Lozano', 'role': 'CONTACT', 'email': 'lab.exercise.physiology@gmail.com', 'phone': '+34910677866'}, {'name': 'Ana B Peinado Lozano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of physical activity and sport sciences', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Ana B Peinado Lozano', 'role': 'CONTACT', 'email': 'lab.exercise.physiology@gmail.com', 'phone': '910677866', 'phoneExt': '+34'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'In accordance with the law 15/1999 on the protection of personal data, the personal data required are those necessary for scientific purposes, for possible studies that may be carried out. In none of these possible studies will your name appear and your identity will not be revealed to any person except to fulfil the purposes of the study, and in the event of a medical emergency or legal requirement. Any personally identifiable information will be retained and processed under secure conditions for the purpose of determining the results of possible studies. The results of these studies may be communicated to health authorities and the scientific community through conferences and/or publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Politecnica de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ANA BELEN PEINADO LOZANO', 'investigatorAffiliation': 'Universidad Politecnica de Madrid'}}}}