Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT03980860
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2019-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Two Exercise Programs on Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a case/control study comparing overweight/obese patients of three different groups (control, HIIT, LIT). The goal of a case/control is to show whether exposure to HIIT, two times a week for 6 weeks will decrease lean body mass versus control and LIT. If it turns out that lean body mass does decrease, then HIIT is not an effective exercise modality for overweight/obese patients, and in fact LIT or control may be a better option.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-24', 'studyFirstSubmitDate': '2019-06-06', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body fat', 'timeFrame': '6 weeks', 'description': 'Reduction in body fat'}, {'measure': 'Lean body mass', 'timeFrame': '6 weeks', 'description': 'Retention of lean body mass'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '6 weeks', 'description': 'Reduction of blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the effectiveness of two exercise programs (High Intensity Interval Training/HIIT and Low Intensity (LIT) Long Duration training) on decreasing fat mass and preserving lean body mass in obese patients. What the investigators are proposing is that HIIT is less effective because it will most likely decrease lean body mass in obese patients, whereas LIT decreases fat mass and conserves lean body tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anyone with a BMI of 25 and above\n\nExclusion Criteria:\n\n* Those that cannot exercise'}, 'identificationModule': {'nctId': 'NCT03980860', 'briefTitle': 'Effect of Two Exercise Programs on Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rowan University'}, 'officialTitle': 'Effect of HIIT vs Low Intensity Training on Fat Loss in Obese Patients', 'orgStudyIdInfo': {'id': 'Pro2019000482'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HIIT (High Intensity Interval Training)', 'description': 'Subjects are undergoing high intensity interval training', 'interventionNames': ['Other: Exercise Type']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low intensity training long duration', 'description': 'Subjects are undergoing a lower intensity training program for a long duration', 'interventionNames': ['Other: Exercise Type']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No exercise program intervention (usual care)'}], 'interventions': [{'name': 'Exercise Type', 'type': 'OTHER', 'description': 'The implementation of 2 types of exercise programs to reduce body fat', 'armGroupLabels': ['HIIT (High Intensity Interval Training)', 'Low intensity training long duration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08084', 'city': 'Stratford', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rowan SOM Family Medicine', 'geoPoint': {'lat': 39.82678, 'lon': -75.01545}}], 'overallOfficials': [{'name': 'Adarsh Gupta, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rowan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rowan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Family Medicine', 'investigatorFullName': 'Adarsh Gupta, DO, MS, FACOFP', 'investigatorAffiliation': 'Rowan University'}}}}