Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-04 @ 5:00 AM
Study NCT ID:
NCT03675867
Status:
UNKNOWN
Last Update Posted:
2018-09-18
First Post:
2018-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-17', 'studyFirstSubmitDate': '2018-09-17', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise', 'timeFrame': 'Day 1', 'description': 'Correlation between resting respiratory parameters: total lung capacity (TLC), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and cardio-respiratory parameters at exercise: maximal oxygen uptake (VO2 max), power achieved during incremental testing (Pmax), blood gas, at the time of the pulmonary function test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood']}, 'descriptionModule': {'briefSummary': 'In obese adolescents, the severity of obesity should not influence the outcome of resting PFT. The amplitudes of the rest PFT should make it possible to predict the performance achieved while exercising on a cycloergometer.\n\nWe wish to highlight the presence of a significant correlation, probably low, between some respiratory parameters at rest, and cardio-vascular parameters at the exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese teenagers with previous PFT available in the medical record', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged \\>12 y.o and \\<18 y.o\n* BMI \\> 30\n* with a previous pulmonary function test (PFT) available in the medical record'}, 'identificationModule': {'nctId': 'NCT03675867', 'acronym': 'EFRADO', 'briefTitle': 'Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers', 'orgStudyIdInfo': {'id': 'P/2018/390'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese teenagers', 'interventionNames': ['Other: Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise']}], 'interventions': [{'name': 'Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise', 'type': 'OTHER', 'description': 'Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise', 'armGroupLabels': ['Obese teenagers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amine Sediki, Int', 'role': 'CONTACT', 'phone': '0033381218135'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Amine SEDIKI', 'role': 'CONTACT', 'email': 'amine.sediki10@gmail.com', 'phone': '0033381218135'}], 'overallOfficials': [{'name': 'Bruno Degano, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}