Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT03509818
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2018-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059385', 'term': 'Plyometric Exercise'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Description of the sample'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum Klotho levels', 'timeFrame': 'Baseline and one hour', 'description': 'Change from baseline to acute exercise session'}], 'secondaryOutcomes': [{'measure': 'Change in Cardiorespiratory Fitness VO2max', 'timeFrame': 'Baseline', 'description': 'For this Variable All people Will perform a exercise test on treadmill (Tecnhogym run race 1400HC; Gambettola, Italy), in this way we determinate the VO2max. Through the modifies Balke protocol. The gas Exchange data Will measured breath by breath using open circuit spirometry and specific face mask for Fitmate, Cosmed; Vmax 29C, Sensormedics machine.'}, {'measure': 'Change in Body Composition', 'timeFrame': 'Baseline', 'description': 'The age in years; height in centimeters (tallimeter Ano Sayol SL, Barcelona, Spain); weight in kilograms (Inbody 720, Microcaya) and we can derive from this data the variable of Body Mass Index (BMI) calculated as weight (kg)/height (m2).'}, {'measure': 'Change in Body Composition, Body muscle mass Index', 'timeFrame': 'Baseline', 'description': 'For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)'}, {'measure': 'Change in Body Composition, % of Fat Mass', 'timeFrame': 'Baseline', 'description': 'For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)'}, {'measure': 'Change in Body Composition, Total Muscle Mass', 'timeFrame': 'Baseline', 'description': 'For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)'}, {'measure': 'Change in Body Composition, Visceral Fat Index.', 'timeFrame': 'Baseline', 'description': 'For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA). This value is really important to determine a cardiovascular risk.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Klotho', 'Exercise', 'Physical Fitness'], 'conditions': ['Healthy Population']}, 'descriptionModule': {'briefSummary': 'Exercise program in serum Klotho levels', 'detailedDescription': 'This study aims to analiyze the effects of acute exercise in serum Klotho levels attending physical fitness in healthy population'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy people between 20 and 45 years old\n\nExclusion Criteria:\n\n* acute and chronic disease, people who take medication and supplements, smoker.'}, 'identificationModule': {'nctId': 'NCT03509818', 'acronym': 'CoFiKSa', 'briefTitle': 'Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population: Response and Adaptation', 'orgStudyIdInfo': {'id': 'Ref 47/764390.09/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plyometric', 'description': 'Effects of plyometric acute exercise', 'interventionNames': ['Other: plyometric exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic', 'description': 'Effects of aerobic acute exercise', 'interventionNames': ['Other: Aerobic exercise']}], 'interventions': [{'name': 'plyometric exercise', 'type': 'OTHER', 'description': 'acute plyometric exercise', 'armGroupLabels': ['Plyometric']}, {'name': 'Aerobic exercise', 'type': 'OTHER', 'description': 'acute aerobic exercise', 'armGroupLabels': ['Aerobic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28670', 'city': 'Madrid', 'state': 'Villaviciosa de Odon', 'country': 'Spain', 'facility': 'Escuela de Doctorado e Invesitgacion, Universidad Europea', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Valentin Fernandez Elias, Ph', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Europea de Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Exercise Physiology', 'investigatorFullName': 'Margarita Perez', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}