Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT03479658
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2018-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose-effect of HIIT on Cardiovascular Health of Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-02', 'studyFirstSubmitDate': '2018-02-20', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cardiorespiratory fitness', 'timeFrame': 'Change from baseline cardiorespiratory fitness at eight weeks', 'description': '20m shuttle run test (Alpha battery)'}], 'secondaryOutcomes': [{'measure': 'Change in Body fat', 'timeFrame': 'Change from baseline body fat at eight weeks', 'description': 'Body fat percent measured by bioimpedance'}, {'measure': 'Change in Ankle-brachial index', 'timeFrame': 'Change from baseline Ankle-brachial index at eight weeks', 'description': 'Automated simultaneous blood pressure measurement'}, {'measure': 'Change in Dietary habits', 'timeFrame': 'Change from baseline Dietary habits at eight weeks', 'description': 'Food frequency questionnaire and 24h recall'}, {'measure': 'Change in Muscular strength', 'timeFrame': 'Change from baseline Muscular strength at eight weeks', 'description': 'Handgrip strength and long jump (Alpha battery)'}, {'measure': 'Change in speed-agility', 'timeFrame': 'Change from baseline speed agility at eight weeks', 'description': '4x10m speed agility test (Alpha battery)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIIT', 'nutritional education', 'Dose-effect', 'school', 'children', 'cardiovascular', 'adiposity', 'blood pressure', 'fitness'], 'conditions': ['Cardiovascular Diseases Risk', 'Adiposity']}, 'descriptionModule': {'briefSummary': 'An adequate physical activity level has important effects on cardiovascular health of children. However, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. High intensity interval training (HIIT) has emerged as an effective strategy for improving physical and mental health in children. To note that HIIT can be completed in a shorter period of time and its results in physical health seem to be equivalent to those obtained in longer sessions of traditional aerobic training. However, there is no information about the dose of HIIT needed to obtain significant effects on cardiovascular health of children.\n\nThe adoption of healthy dietary habits is also important in the prevention of obesity and cardiovascular diseases.\n\nSchool-based programs including physical activity and nutritional education have been recommended as important components of programs aiming to prevent obesity and cardiovascular diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll school children able to attend the physical education sessions of the school\n\n\\-\n\nExclusion Criteria:\n\n* Children with medical condition that limits physical activity'}, 'identificationModule': {'nctId': 'NCT03479658', 'briefTitle': 'Dose-effect of HIIT on Cardiovascular Health of Children', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Pública de Navarra'}, 'officialTitle': 'Dose-effect of HIIT on Cardiovascular Health of Children Aged 9 to 10 Years Old Participating in a School Based Multidisciplinary Intervention Program: a Pilot Study', 'orgStudyIdInfo': {'id': 'PI-018/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIIT two sessions', 'description': 'Two sessions per week of HIIT + nutritional education (1 session/week)', 'interventionNames': ['Behavioral: High intensity interval training', 'Behavioral: Nutritional education']}, {'type': 'EXPERIMENTAL', 'label': 'HIIT one session', 'description': 'One session per week of HIIT + nutritional education (1 session/week)', 'interventionNames': ['Behavioral: High intensity interval training', 'Behavioral: Nutritional education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nutritional education', 'description': 'Nutritional education (1 session/week)', 'interventionNames': ['Behavioral: Nutritional education']}], 'interventions': [{'name': 'High intensity interval training', 'type': 'BEHAVIORAL', 'description': 'Two schools with four classes/groups of 4th degree of children will participate in the pilot study (i.e., age of children 9-10 years old). One of them has two physical education (PE) sessions per week and the other has only one PE session per week. In the school with two PE sessions, two classes will be randomly assigned to HIIT (2 sessions/week) +nutrition group, and two to the nutrition group. Similarly, in the school with one PE session per week, two classes will be randomly assigned to HIIT (1 session/week) + nutrition and two classes to the nutrition goup. Both HIIT and nutritional education sessions will be integrated integrated into the physical education and sciences sessions of the schools. The duration of the intervention will be of eight weeks.', 'armGroupLabels': ['HIIT one session', 'HIIT two sessions']}, {'name': 'Nutritional education', 'type': 'BEHAVIORAL', 'description': 'School-based nutritional education on healthy dietary habits', 'armGroupLabels': ['HIIT one session', 'HIIT two sessions', 'Nutritional education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Department of Health Sciences, Universidad Pública de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Pública de Navarra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Idoia Labayen', 'investigatorAffiliation': 'Universidad Pública de Navarra'}}}}