Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-03 @ 8:11 AM
Study NCT ID:
NCT03297333
Status:
TERMINATED
Last Update Posted:
2021-10-04
First Post:
2017-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise Mode on Cardiac Fat and Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'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'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Covid/19', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2017-09-26', 'studyFirstSubmitQcDate': '2017-09-28', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Epicardial adipose tissue (EAT)', 'timeFrame': '2 assessment points: at baseline and week 4', 'description': 'EAT will be measured using cardiac Magnetic Resonance'}, {'measure': 'Changes in Vascular Health', 'timeFrame': '2 assessment points: at baseline and week 4', 'description': 'Atrial stiffness will be measured using a pulse wave analysis'}], 'secondaryOutcomes': [{'measure': 'Changes in Paracardial adipose tissue (PAT)', 'timeFrame': '2 assessment points: at baseline and week 4', 'description': 'PAT will be measured using cardiac Magnetic Resonance'}, {'measure': 'Changes in Body Composition', 'timeFrame': '2 assessment points: at baseline and week 4', '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 4', '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 4', 'description': 'Muscular Strength will be assessed by 1 repetition maximum (1RM) test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Exercise', 'Cardiac Fat', 'Cardiac Magnetic Resonance', 'Vascular Health'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to study the effects of exercise energy expenditure matched vigorous dynamic resistance training and aerobic training on cardiac fat, and its relationship to cardiac function and geometry using cardiac Magnetic Resonance Imaging.', 'detailedDescription': 'Exercise-induced weight-loss is one of the most common strategies for reducing excess fat in overweight and obese individuals. Although vigorous intensity may be more favorable promoting positive cardiac adaptations compared to low-moderate intensity, evidence of the positive effects of different exercise modes needs to be explored to allow for realistic comparisons with other strategies. Research using cardiac Magnetic Resonance Imaging that compares the effects of different modes of exercise - matched by exercise energy expenditure - on epicardial adipose tissue and paracardial adipose tissue, and how these interventions modify cardiac function and geometry have not been previously explored in obesity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary\n* Caucasian\n* BMI \\>30 kg/m2 and \\< 39.9 kg/m2\n\nExclusion Criteria:\n\n* Known cardiovascular, metabolic, pulmonary disease or conditions\n* Muscular-skeletal injuries\n* Taking medications that affect endocrine or cardiovascular function\n* Hypertension\n* Being engaged in low intensity strength training more than two times per week or moderate-high intensity of any type of frequency\n* Being pregnant\n* Cigarette smoking\n* Having non-removable pieces or devices incompatible with DXA and CMR assessment.'}, 'identificationModule': {'nctId': 'NCT03297333', 'briefTitle': 'Effects of Exercise Mode on Cardiac Fat and Function', 'organization': {'class': 'OTHER', 'fullName': 'Southern Illinois University Edwardsville'}, 'officialTitle': 'Effects of Exercise Mode on Cardiac Fat and Function', 'orgStudyIdInfo': {'id': '16-1208-4C-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance training group', 'description': "Resistance training will consist of a supervised circuit training 3 sessions/week for approximately 45-50 min/session. The circuit will include 7 strength exercises engaging the major muscle groups (leg press, rows, back squats, weighted crunches, deadlifts, bench press, and squat jumps with weights). The participants will perform 3 sets of 10 repetitions with resting periods of 30 seconds between exercises, and 2 minutes between sets. The overall OMNI-Resistance Exercise Scale per set will range between 8-10. Heart rate and exercise energy expenditure during the workout will be monitored. The load will be changed depending on the participants' perception when needed. In addition, the intensity will be monitored assessing Lactate concentrations at baseline and at the end of each session. Circuit will be repeated until meeting the targeted exercise energy expenditure of 450-500 kcal/session.", 'interventionNames': ['Other: Resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic interval training group', '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. 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, and the second period the intensity will be reduced for 2 minutes. The speed/incline will be changed depending on the participants' heart rate and perception using the Borg's rating of perceived exertion as needed. Heart rate and exercise energy expenditure during the workout will be monitored. Intensity will be monitored assessing Lactate concentrations at the end of each session. Intervals will be repeated until meeting the targeted exercise energy expenditure (450-500 kcal/session).", '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': 'Resistance training', 'type': 'OTHER', 'description': 'The resistance training group', 'armGroupLabels': ['Resistance training group']}, {'name': 'Aerobic interval training', 'type': 'OTHER', 'description': 'The aerobic interval training group', 'armGroupLabels': ['Aerobic interval training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62026', 'city': 'Edwardsville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University of Edwardsville', 'geoPoint': {'lat': 38.81144, 'lon': -89.95316}}], 'overallOfficials': [{'name': 'Maria Fernandez del Valle, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Illinois University of Edwardsville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Illinois University Edwardsville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}