Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-09 @ 6:01 PM
Study NCT ID:
NCT02503995
Status:
COMPLETED
Last Update Posted:
2015-07-22
First Post:
2015-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise in Pregnancy Evaluative Controlled Study
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': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2015-07-10', 'studyFirstSubmitQcDate': '2015-07-17', 'lastUpdatePostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate Variability - Time Point 1', 'timeFrame': '10-12 weeks gestation', 'description': 'Determined from 3-lead ECG, assessed as absolute value'}, {'measure': 'Heart Rate Variability - Time Point 2', 'timeFrame': '24-28 weeks gestation', 'description': 'Determined from 3-lead ECG, assessed as absolute value'}, {'measure': 'Heart Rate Variability - Time Point 3', 'timeFrame': '34-36 weeks gestation', 'description': 'Determined from 3-lead ECG, assessed as absolute value'}, {'measure': 'Heart Rate Variability - Time Point 4', 'timeFrame': '12 weeks post-birth', 'description': 'Determined from 3-lead ECG, assessed as absolute value'}, {'measure': 'Cardiac Stroke Volume - Time Point 1', 'timeFrame': '10-12 weeks gestation', 'description': 'Determined from thoracic impedance cardiogram, assessed as absolute value'}, {'measure': 'Cardiac Stroke Volume - Time Point 2', 'timeFrame': '24-28 weeks gestation', 'description': 'Determined from thoracic impedance cardiogram, assessed as absolute value'}, {'measure': 'Cardiac Stroke Volume - Time Point 3', 'timeFrame': '34-36 weeks gestation', 'description': 'Determined from thoracic impedance cardiogram, assessed as absolute value'}, {'measure': 'Cardiac Stroke Volume - Time Point 4', 'timeFrame': '12 weeks post-birth', 'description': 'Determined from thoracic impedance cardiogram, assessed as absolute value'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '25690105', 'type': 'RESULT', 'citation': "Carpenter RE, D'Silva LA, Emery SJ, Uzun O, Rassi D, Lewis MJ. Changes in heart rate variability and QT variability during the first trimester of pregnancy. Physiol Meas. 2015 Mar;36(3):531-45. doi: 10.1088/0967-3334/36/3/531. Epub 2015 Feb 18."}, {'pmid': '24345774', 'type': 'RESULT', 'citation': "D'Silva LA, Davies RE, Emery SJ, Lewis MJ. Influence of somatic state on cardiovascular measurements in pregnancy. Physiol Meas. 2014 Jan;35(1):15-29. doi: 10.1088/0967-3334/35/1/15. Epub 2013 Dec 17."}, {'pmid': '26296647', 'type': 'DERIVED', 'citation': "Carpenter RE, Emery SJ, Uzun O, D'Silva LA, Lewis MJ. Influence of antenatal physical exercise on haemodynamics in pregnant women: a flexible randomisation approach. BMC Pregnancy Childbirth. 2015 Aug 22;15:186. doi: 10.1186/s12884-015-0620-2."}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate whether there are measurable differences in CHANS function in pregnant women who receive only standard antenatal care compared with those who additionally undertake a programme of regular physical exercise.', 'detailedDescription': "The health benefits of physical exercise in the non-pregnant population are generally appreciated but its influence during pregnancy has not been clearly demonstrated. The focus of this proposal is to obtain for the first time a comprehensive understanding of the influence of regular physical exercise during pregnancy on cardiovascular, haemodynamic and autonomic nervous system (CHANS) parameters during pregnancy and following childbirth. This will involve assessing heart rate variability and cardiac stroke volume. This study will allow the investigators to compare CHANS parameters in pregnant women who are randomly assigned into three groups: a 'standard care' group and two groups who engage in a supervised programme of physical exercise (either land-based or water-based). The investigators will assess CHANS parameters at three stages during pregnancy and on one occasion following childbirth. This will allow the influence of regular (weekly) physical exercise on CHANS physiology to be assessed during advancing gestation. The investigators will thus use this study to provide initial evidence of the health benefits of regular and specific forms of antenatal physical exercise."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants were apparently healthy pregnant women aged 18 years or over, with no existing complications of pregnancy at their 12-week dating scan.\n\nExclusion Criteria:\n\n* Exclusion criteria were: a history of cardiovascular or chronic respiratory problems, sleep apnoea, or central/peripheral nervous system disorder.'}, 'identificationModule': {'nctId': 'NCT02503995', 'acronym': 'EXPECT', 'briefTitle': 'Exercise in Pregnancy Evaluative Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Swansea University'}, 'officialTitle': 'Influence of Regular Antenatal Physical Exercise on Cardiovascular, Haemodynamic and Autonomic Nervous System (CHANS) Function During and After Pregnancy', 'orgStudyIdInfo': {'id': '12/WA/0081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No intervention', 'description': 'Participants not undertaking any additional exercise', 'interventionNames': ['Behavioral: Physical Exercise Participation']}, {'type': 'EXPERIMENTAL', 'label': 'Water-based exercise group', 'description': 'Participants assigned to a water-based exercise group', 'interventionNames': ['Behavioral: Physical Exercise Participation']}, {'type': 'EXPERIMENTAL', 'label': 'Land-based exercise group', 'description': 'Participants assigned to a land-based exercise group', 'interventionNames': ['Behavioral: Physical Exercise Participation']}], 'interventions': [{'name': 'Physical Exercise Participation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Land-based exercise group', 'No intervention', 'Water-based exercise group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Simon J Emery, MB BCh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abertawe Bro Morgannwg University Health Board'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swansea University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr Michael Lewis', 'investigatorAffiliation': 'Swansea University'}}}}