Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT04802005
Status:
WITHDRAWN
Last Update Posted:
2021-09-21
First Post:
2021-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Short-term Aerobic Interval Exercise Program on Cardiac Fat and Function in Women With Obesity: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI moved to another institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2021-03-13', 'studyFirstSubmitQcDate': '2021-03-13', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Cardiac Adipose Tissue (CAT)', 'timeFrame': '2 assessment points: at baseline and week 5', 'description': 'CAT will be measured using cardiac Magnetic Resonance'}, {'measure': 'Changes in Cardiac Function', 'timeFrame': '2 assessment points: at baseline and week 5', 'description': 'Cardiac Function will be measured using cardiac Magnetic Resonance'}], 'secondaryOutcomes': [{'measure': 'Changes in Body Composition', 'timeFrame': '2 assessment points: at baseline and week 5', 'description': 'Body composition will be measured using dual-energy x-ray absorptiometry'}, {'measure': 'Changes in Cardiorespiratory Function', 'timeFrame': '2 assessment points: at baseline and week 5', 'description': 'Cardiorespiratory Function will be measured on a treadmill with a metabolic cart'}, {'measure': 'Changes in Muscular Strength', 'timeFrame': '2 assessment points: at baseline and week 5', 'description': 'Muscular Strength will be assessed through 1 repetition maximum (1RM).'}, {'measure': 'Changes in Blood Pressure', 'timeFrame': '2 assessment points: at baseline and week 5', 'description': 'Blood pressure will be measured using pulse wave analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac fat', 'Cardiac function', 'Aerobic interval training', 'Cardiac Magnetic Resonance', 'Vascular health'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to the study the effects of an aerobic interval training program on cardiac fat, and its relationship to cardiac function using cardiac Magnetic Resonance Imaging.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* females, age 18-40 years old, body mass index (BMI) ≥ 30 kg/m2 and \\< 39.9 kg/m2, without known metabolic and/or cardiovascular disease\n\nExclusion Criteria:\n\n* known CV, metabolic or pulmonary diseases or conditions, muscular-skeletal injuries (i.e. spine, knees, hips or shoulders, taking medications that affect endocrine or cardiovascular function, hypertension, being engaged in moderate intensity exercise more than two times per week or moderate-high intensity training of any type and frequency, being pregnant, cigarette smoking, having non-removable pieces or devices incompatible with DXA and CMR assessment'}, 'identificationModule': {'nctId': 'NCT04802005', 'briefTitle': 'Effects of a Short-term Aerobic Interval Exercise Program on Cardiac Fat and Function in Women With Obesity: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Southern Illinois University Edwardsville'}, 'officialTitle': 'Effects of a Short-term Aerobic Interval Exercise Program on Cardiac Fat and Function in Women With Obesity: A Pilot Study', 'orgStudyIdInfo': {'id': '1063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic interval', 'description': "Aerobic interval will consist of a supervised aerobic interval training sessions 3 times/week. Duration will range between 45-50 min/session depending on the exercise energy expenditure (target expenditure \\~450-500kcal/session). Each interval will have a total duration of 5 min, and it will be divided into 2 periods. The first period will consist of 3 minutes of high-intensity activity at 70-85% of predicted HRmax, and for the second period the intensity will be reduced to 60-65% of predicted HRmax for 2 minutes. The training sessions will be carried out outdoors at the trails located on campus. The activity will consist of walking and/or light jogging. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion (RPE) as needed. The RPE for the first period range will be 13-17 (15-17 at the end of the period) and 10-12 for the second period.", 'interventionNames': ['Other: Aerobic Interval Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants in the control group will not participate in the training programs.'}], 'interventions': [{'name': 'Aerobic Interval Training', 'type': 'OTHER', 'description': 'The aerobic interval training group', 'armGroupLabels': ['Aerobic interval']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62026', 'city': 'Edwardsville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University Edwardsville', 'geoPoint': {'lat': 38.81144, 'lon': -89.95316}}], 'overallOfficials': [{'name': 'Maria Fernandez Del Valle, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Illinois University of Edwardsville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Illinois University Edwardsville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Fernandez Del Valle', 'investigatorAffiliation': 'Southern Illinois University Edwardsville'}}}}