Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-12 @ 7:18 AM
Study NCT ID:
NCT01718405
Status:
UNKNOWN
Last Update Posted:
2012-10-31
First Post:
2012-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-29', 'studyFirstSubmitDate': '2012-10-10', 'studyFirstSubmitQcDate': '2012-10-29', 'lastUpdatePostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Genetic Variation Associated with Different Cognitive Functioning', 'timeFrame': 'Two years', 'description': 'Genetic variation will be analyzed by extraction of genomic DNA from blood leukocytes, using a salting out procedure, and then by using polymerase chain reaction restriction fragment lengths polymorphism (PCR-RELP) methods for detection of single nucleotide polymorphism. A mutation will be discriminated by digestion with specific restriction endonucleases.'}], 'primaryOutcomes': [{'measure': 'Cognitive Functioning After Exercise', 'timeFrame': 'Five minutes', 'description': 'Computerized battery of tests evaluating cognitive functioning'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Executive Function']}, 'descriptionModule': {'briefSummary': 'Studies have shown that an acute bout of aerobic exercise positively effects cognition, mainly executive functioning; however the effect is not observed among all people and it is not clear whether only aerobic exercise can produce this effect or possibly also resistant exercise. The main purpose of our study is to examine whether genetic variation is a moderator of this effect and whether resistant exercise is comparable to aerobic exercise in improving cognition following a single bout of exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physical Education Students\n* Able to sign consent form\n\nExclusion Criteria:\n\n* Competitive athletes\n* Smokers\n* Neurologic or psychologic orders\n* Chronic diseases\n* Head Injuries\n* Hospitalization in the previous 3 months\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT01718405', 'briefTitle': 'Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': '0049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Group', 'description': 'Each individual subject will give a blood sample for genetic analysis and undertake an exercise session and a rest session as a control. Cognitive function will be tested before and after each session.', 'interventionNames': ['Other: Cognitive function after exercise test', 'Genetic: Blood sample analysis']}], 'interventions': [{'name': 'Cognitive function after exercise test', 'type': 'OTHER', 'description': 'The individual subjects will participate in 3 sessions of either aerobic exercise, resistance exercise or rest, in a random order. Before and after each session, the subject will take computerized cognitive tests.', 'armGroupLabels': ['Exercise Group']}, {'name': 'Blood sample analysis', 'type': 'GENETIC', 'description': 'In the first evaluation session blood samples will be taken from each subject and will be analysed for genetic polymorphism.', 'armGroupLabels': ['Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'country': 'Israel', 'contacts': [{'name': 'Raffael Carasso, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sharon Tsuk, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Wingate Institute', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'centralContacts': [{'name': 'Sharon Tsuk, PhD', 'role': 'CONTACT', 'email': 'sharontsuk1@gmail.com', 'phone': '972-522-640642'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}