Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT04359433
Status:
WITHDRAWN
Last Update Posted:
2024-05-14
First Post:
2020-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intermittent Exercise Among Students
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding issue', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal of cardiometabolic risk related index', 'timeFrame': '3th month after enrollment', 'description': 'Cardiometabolic risk related index includes fasting blood glucose, blood lipids, blood pressure and abdominal obesity.Cardiometabolic risk related index would be set to 1 as at least 2 indexs mentioned were abnormal while 0 for less than 2.'}], 'secondaryOutcomes': [{'measure': 'Change of Waist-to-height ratio', 'timeFrame': 'Baseline, 12th months after enrollment', 'description': "Waist-to-height ratio is calculated by the formula ：Waist-to-height ratio=waistline (cm)/height(cm). All the participates' Waist-to-height ratio would be calculated at baseline and 12th months after enrollment. The change would be manifested in the situatuion of the difference."}, {'measure': 'Change of Body Mass Index', 'timeFrame': 'Baseline, 12th months after enrollment', 'description': "Body Mass Index is calculated by the formula ：Body Mass Index=weight(kg)/(height(cm))\\^2. All the participates' Body Mass Index would be calculated at baseline and 12th months after enrollment. The change would be manifested in the situatuion of the difference."}, {'measure': 'Change of hipline', 'timeFrame': 'Baseline, 12th months after enrollment', 'description': "All the participates' hipline would be measured at baseline and 12th months after enrollment. The change would be manifested in the situatuion of the difference."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiometabolic', 'children', 'Waist to height ratio, WHtR', 'Intermittent Anaerobic Exercise'], 'conditions': ['Cardiometabolic Risk']}, 'descriptionModule': {'briefSummary': 'Evaluate the effectiveness of intermittency anaerobic exercise interventions among the students with high risk of cardiometabolic .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criterias:\n\n* Male: Waist-to-height ratio≥0.463\n* Female： Waist-to-height ratio≥0.469\n* Students with cardiometabolic risk factors include elevated BP, dyslipidaemia, elevated fasting blood glucose (FBG) and central obesity.\n\nExclusion Criterias:\n\n* Participates with severe disease conditions include cardiac insufficiency, respiratory system relate diseases, immunodeficiency or severe malnutrition, ect\n* Taking or having taken weight-loss drugs\n* Participates unsuitable or improper to participate the study'}, 'identificationModule': {'nctId': 'NCT04359433', 'briefTitle': 'Intermittent Exercise Among Students', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Evaluation the Effectiveness of Intermittent Anaerobic Exercise Among the Students With Cardiometabolic Risk', 'orgStudyIdInfo': {'id': 'IES-EKYY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard group', 'description': 'The participates in this group would provide normal health education of scientific and rational diet.'}, {'type': 'EXPERIMENTAL', 'label': 'Exercise intervention group', 'description': 'Besides normal health education of scientific and rational diet，the participates in this group would be suggested to carry out an anaerobic exercise named Tabata.', 'interventionNames': ['Behavioral: Exercise programme']}], 'interventions': [{'name': 'Exercise programme', 'type': 'BEHAVIORAL', 'description': 'Exercise programme includes 8 anaerobic movements choosen from Tabata. This exercise programme workout is aimed at body fat reduction, and the structure is as follows:\n\n* 8 anerobic movements in 20 seconds is a set\n* Rest for 10 seconds before another set\n* Finish 4 sets every time, it shall take you 4 minutes\n* Do 4 sets 2 to 3 times a week', 'armGroupLabels': ['Exercise intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Weili Yan, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}