Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01407458
Status:
UNKNOWN
Last Update Posted:
2011-08-02
First Post:
2011-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of a Structured Physical Activity Program on Bone Strength and Psycho-Motor Learning of Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-01', 'studyFirstSubmitDate': '2011-07-26', 'studyFirstSubmitQcDate': '2011-08-01', 'lastUpdatePostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone strength', 'timeFrame': 'One year', 'description': 'Examination of bone strength will be carried out by using a measuring device called Sunlight Omnisense. This device uses SOS (Speed of Sound) to check bone strength and density.'}, {'measure': 'Bone density', 'timeFrame': 'One year', 'description': 'Examination of bone density will be carried out by using a measuring device called Sunlight Omnisense. This device uses SOS (Speed of Sound) to check bone strength and density.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bone Strength', 'Bone Density']}, 'descriptionModule': {'briefSummary': 'To examine the impact of a structured physical activity program focused on bone strength in elementary school children in the framework of their physical education classes on:\n\n1. Bone strength of children participating in the activity.\n2. Physical variables and psycho-motor capabilities: vertical jumping strength, horizontal jumping strength, static balance, dynamic balance and coordination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First and second grade pupils\n* Healthy\n\nExclusion Criteria:\n\n* Medical condition does not permit participation in physical education class'}, 'identificationModule': {'nctId': 'NCT01407458', 'briefTitle': 'The Impact of a Structured Physical Activity Program on Bone Strength and Psycho-Motor Learning of Young Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': '0043-11-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental Group', 'description': 'Children doing additional exercises with upper limbs in physical education class', 'interventionNames': ['Other: Upper Limb Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Children doing normal physical education exercises', 'interventionNames': ['Other: Normal physical exercises']}], 'interventions': [{'name': 'Upper Limb Exercises', 'type': 'OTHER', 'description': 'Upper limb exercises', 'armGroupLabels': ['Experimental Group']}, {'name': 'Normal physical exercises', 'type': 'OTHER', 'description': 'Exercises usually done by children in physical education classes', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Eias Kassem, MD', 'role': 'CONTACT', 'email': 'eiask@hy.health.gov.il', 'phone': '972-4-630-4331'}, {'name': 'Eias Kassem, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Eias Kassem', 'oldOrganization': 'Hillel Yaffe Medical Center'}}}}