Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-03 @ 12:35 AM
Study NCT ID:
NCT01885234
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D059385', 'term': 'Plyometric Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2013-06-05', 'studyFirstSubmitQcDate': '2013-06-19', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'First ventilatory threshold', 'timeFrame': 'day 1 and 10 weeks after training'}], 'primaryOutcomes': [{'measure': 'glycated hemoglobin', 'timeFrame': 'day 1 and 10 weeks after training'}], 'secondaryOutcomes': [{'measure': 'HOMA', 'timeFrame': 'day 1 and 10 weeks after training'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glycated hemoglobin', 'HOMA', 'Pregnancy', 'aerobic exercise'], 'conditions': ['Pregnancy', 'Gestational Diabetes Mellitus', 'Chronic Hypertension in Obstetric Context']}, 'descriptionModule': {'briefSummary': "The aim of the present study is verify glycated hemoglobin (HbA1c) and HOMA behavior in pregnant women with gestational diabetes or chronic hypertension after an aerobic training in cycle-ergometer. The sample is composed by 64 pregnant and sedentary women, 20 weeks' pregnant.\n\nTwo experimental groups (gestational diabetes and chronic hypertension, n = 16 each) will perform a low-intensity aerobic training in cycle-ergometer, three times/week, for 45 minutes each session. Two control groups (gestational diabetes and chronic hypertension, n = 16 each) will perform an unique session/week of relaxation and stretching.\n\nOutcomes: first ventilatory threshold, HbA1c,HOMA, type of delivery, weight and height of the newborn.", 'detailedDescription': "The statistical analysis will consist of:\n\n* descriptive statistic;\n* Levene's test\n* Shapiro Wilk's normality test\n* Parametric or non-parametric test\n* a=0.05\n* SPSS 17.0"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '27 Weeks', 'minimumAge': '20 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 20 years;\n* gestational age between 20 and 27 weeks (date of the last period and confirmed by ultrasound);\n* Only one foetus in the womb;\n* Without orthopedic limitations;\n* Non-smoker;\n* Medical clearance for exercise\n\nExclusion Criteria:\n\n* Pre-eclampsia;\n* fetal malformations;\n* Intrauterine fetal death'}, 'identificationModule': {'nctId': 'NCT01885234', 'briefTitle': 'Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Aerobic Training Effect in Pregnant Women With Gestational Diabetes and Chronic Hypertension: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'GDM-HAS120008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise', 'description': 'Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week', 'interventionNames': ['Other: Aerobic exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stretch exercise', 'description': 'Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week', 'interventionNames': ['Other: Stretch exercise']}], 'interventions': [{'name': 'Aerobic exercise', 'type': 'OTHER', 'description': 'Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week', 'armGroupLabels': ['Aerobic exercise']}, {'name': 'Stretch exercise', 'type': 'OTHER', 'description': 'Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week', 'armGroupLabels': ['Stretch exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'José Geraldo L Ramos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HC Porto Alegre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}