Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-01 @ 11:23 AM
Study NCT ID:
NCT01723293
Status:
UNKNOWN
Last Update Posted:
2014-11-14
First Post:
2012-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetal Cardiovascular Response to Maternal Exercise During Third Trimester
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2012-11-05', 'studyFirstSubmitQcDate': '2012-11-05', 'lastUpdatePostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fetal heart rate', 'timeFrame': 'Up to 34 weeks', 'description': 'Fetal heart rate was measured before and after maternal walking exercise at 40 and 60% MaxHR'}], 'secondaryOutcomes': [{'measure': 'Fetal outcomes', 'timeFrame': 'After labor', 'description': 'Birth weight'}, {'measure': 'Maternal outcomes', 'timeFrame': 'During labor', 'description': 'Type of delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fetal heart rate, pregnancy, fetus, cardiovascular system'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to examine the behavior of the fetal heart rate in response to different intensities of acute maternal exercise in training and non-training pregnant women', 'detailedDescription': 'Fetal heart rate is considered an important index of fetal well-being, especially during the third trimester of pregnancy (Rodney JR, Huntley BJ, Rodney WM, 2012). An increase in the FHR of 5-25 beats per min (bpm) in response to maternal exercise has been established as a normal reaction(Riemann,Kanstrup Hansen, 2000)however the normal FHR response to maternal exercise has remained unclear for several reasons\n\nMost of the studies are focused on obtain data in order to examine the fetal heart rate response to maternal exercise using cardiotocography measurements prior to and following maternal exercise'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines\n* Being able to communicate in spanish\n* Giving birth at Hospital Universitario de Fuenlabrada\n\nExclusion Criteria:\n\n* Multiparity\n* Obstetrician complications\n* Being interested in the study after 18 weeks\n* Not being regular in physical exercise program\n* Younger than 18 years old'}, 'identificationModule': {'nctId': 'NCT01723293', 'briefTitle': 'Fetal Cardiovascular Response to Maternal Exercise During Third Trimester', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Madrid'}, 'officialTitle': 'Effect of a Specific Exercise Program During Whole Pregnancy on Fetal Heart Rate Response to Maternal Effort in Third Trimester. A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'Fetal responses to exercise'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Sedentary pregnant women'}, {'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'interventionNames': ['Behavioral: Exercise group']}], 'interventions': [{'name': 'Exercise group', 'type': 'BEHAVIORAL', 'description': 'The physical conditioning program included a total of three 55-60 minute sessions per week. Pregnant women started in 9-12 weeks and finished in 38-40 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.\n\nEach session included a 25-minutes of aerobic exercise, 10-minutes of strength exercise and balance exercise as well, and 10-minutes of pelvic floor muscles training.', 'armGroupLabels': ['Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Perales, PhD student', 'role': 'CONTACT', 'email': 'm.perales.santaella@gmail.com', 'phone': '913364081'}, {'name': 'Ruben Barakat, PhD', 'role': 'CONTACT', 'email': 'barakatruben@gmail.com', 'phone': '913364020'}, {'name': 'Maria Perales, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universidad Politecnica de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Maria Perales, PhD student', 'role': 'CONTACT', 'email': 'm.perales.santaella@gmail.com', 'phone': '913364081'}, {'name': 'Ruben Barakat, PhD', 'role': 'CONTACT', 'email': 'barakatruben@gmail.com', 'phone': '913364020'}], 'overallOfficials': [{'name': 'Rubén Barakat, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Politecnica de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'María Perales Santaella', 'investigatorAffiliation': 'Technical University of Madrid'}}}}