Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-31 @ 4:24 AM
Study NCT ID:
NCT00813657
Status:
COMPLETED
Last Update Posted:
2008-12-23
First Post:
2008-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001724', 'term': 'Birth Weight'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2002-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-22', 'studyFirstSubmitDate': '2008-12-22', 'studyFirstSubmitQcDate': '2008-12-22', 'lastUpdatePostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-03', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gestational Age', 'Birth Weight', 'Anaemia', 'Gestational Diabetes Mellitus', 'Type of Delivery']}, 'descriptionModule': {'briefSummary': 'The investigators investigated the effects of a supervised maternal exercise training program (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health outcomes in a group of previously sedentary healthy women. A matched control group was assessed over the same time period. Given the fact that most studies in the field have used aerobic exercises, here the investigators largely focused on very light resistance, toning exercises.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sedentary (not exercising \\>20 minutes on \\>3 days per week)\n* with singleton\n* not at high risk for preterm delivery (no more than one previous preterm deliveries)\n* women planning to give birth in the same obstetrics hospital department (Hospital Severo Ochoa, Madrid, Spain)\n\nExclusion Criteria:\n\n* not being under medical follow-up throughout the entire pregnancy period were not included in the study\n* women having serious medical condition that prevent them from exercising safely'}, 'identificationModule': {'nctId': 'NCT00813657', 'briefTitle': 'Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Politecnica de Madrid'}, 'officialTitle': 'Effects of Resistance Exercise Training Program Performed During the 2nd and 3rd Trimesters of Pregnancy on Maternal and Newborn Health', 'orgStudyIdInfo': {'id': '01562'}, 'secondaryIdInfos': [{'id': '01562'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Women in the intervention group were enrolled in three sessions/week of individually supervised, resistance exercise training performed over the second and third trimester of pregnancy (in total 26 weeks, \\~80 training sessions). Heart rate (HR) was carefully and individually controlled (≤80% of age-predicted maximum HR value, 220-age) through a heart rate monitor during the training sessions. In brief, each session consisted of 35-40 minutes of exercise divided in a light intensity (≤60% maximal heart rate) warm-up period (\\~8 minutes), followed by toning and very light resistance exercises (\\~20 minutes) and a light intensity cool-down (\\~8 minutes) period. Resistance exercises were performed with barbells (≤3kg per exercise) or low-to-medium resistance bands (Therabands).', 'armGroupLabels': ['Lifestyle counseling']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Politecnica de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ruben Barakat', 'oldOrganization': 'Facultad de Ciencias de la Actividad Física y del Deporte - INEF, Universidad Politécnica de Madrid, Madrid, Spain'}}}}