Viewing Study NCT03898518


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Study NCT ID: NCT03898518
Status: COMPLETED
Last Update Posted: 2020-11-03
First Post: 2019-03-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: The Effects of a Jump Rope Exercise Program on Body Composition and Self-efficacy in Obese Adolescent Girls
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058246', 'term': 'Prehypertension'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'exercise intervention group, control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2011-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-30', 'studyFirstSubmitDate': '2019-03-29', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Fat', 'timeFrame': '12 weeks', 'description': 'Body fat percentage was measured to the nearest 0.1%.'}, {'measure': 'Blood Pressure', 'timeFrame': '12 weeks', 'description': 'Blood pressure was measured in duplicate using an automated sphygmomanometer. The average of the was recorded as the resting blood pressure. Both systolic and diastolic blood pressure were recorded.'}, {'measure': 'Body Mass', 'timeFrame': '12 weeks', 'description': 'Body mass was measured to nearest 0.1kg.'}, {'measure': 'Height', 'timeFrame': '12 weeks', 'description': 'Height was measured to the nearest 1 cm.'}, {'measure': 'Waist Circumference', 'timeFrame': '12 weeks', 'description': 'Waist circumference as measured at midpoint between the lower rib and the iliac crest at the end of a normal expiration using a tap measure.'}, {'measure': 'Lean Body Mass', 'timeFrame': '12 weeks', 'description': 'Lean body mass (kg) was determined using a bioelectrical impedance-meter.'}, {'measure': 'Glucose', 'timeFrame': '12 weeks', 'description': 'Blood glucose concentrations were assessed with a glucose reagent kit.'}, {'measure': 'Insulin', 'timeFrame': '12 weeks', 'description': 'Serum insulin was evaluated using an enzyme-linked immunosorbent assay (ELISA) kit.'}, {'measure': 'Homeostatic Model Assessment - Insulin Resistance', 'timeFrame': '12 weeks', 'description': 'Homeostatic model assessment - insulin resistance was calculated from the fasting plasma blood glucose and insulin levels according to previously established models.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescence', 'exercise', 'body composition', 'insulin sensitivity', 'obesity', 'academic self-efficacy'], 'conditions': ['Prehypertension', 'Blood Pressure', 'Abdominal Obesity', 'Self Efficacy', 'Adiposity', 'Insulin Sensitivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to examine the impact of a 12-week jump rope exercise program on body composition, blood pressure, insulin resistance, and academic self-efficacy in prehypertensive adolescent obese girls. Forty-eight prehypertensive adolescent obese girls participated in this study. The girls were randomly divided into the jump rope exercise intervention group (EX, n=24) and control group (CON, n=24). The EX group performed a jump rope training program at 40-70% of their heart rate reserve (HRR) 5 days/week for 12 weeks (sessions 50 minutes in duration). The CON group did not participate in any structure or unstructured exercise protocol. Blood pressure, body fat percentage, waist circumference, blood glucose and insulin, homeostatic model assessment - insulin resistance, and Academic Self-Efficacy were measured before and after the 12-weeks study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prehypertensive\n* sedentary (no regular exercise training or physical activity within the last year)\n* no weight loss diet during the last six months\n* obese\n\nExclusion Criteria:\n\n* pregnancy\n* chronic disease\n* daily medication use'}, 'identificationModule': {'nctId': 'NCT03898518', 'briefTitle': 'The Effects of a Jump Rope Exercise Program on Body Composition and Self-efficacy in Obese Adolescent Girls', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University'}, 'officialTitle': 'The Effects of a 12-week Jump Rope Exercise Program on Body Composition, Insulin Sensitivity, and Academic Self-efficacy in Obese Prehypertensive Adolescent Girls', 'orgStudyIdInfo': {'id': 'UNOVRLJRSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group was in the facility for all jump rope exercise sessions but did not participate in the exercise intervention.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'The experimental group performed the jump rope exercise intervention.', 'interventionNames': ['Other: 12-week jump rope exercise program']}], 'interventions': [{'name': '12-week jump rope exercise program', 'type': 'OTHER', 'description': 'Each jump rope exercise session of the program was performed for 50 minute, with a 5 minute warm-up and cool-down. Sessions were performed once a day, 5 days a week, for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool-down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased form 40-50% heart rate reserve (HRR) in weeks 1-4 and 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Ever subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity.', 'armGroupLabels': ['Experimental Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chonnam National University', 'class': 'OTHER'}, {'name': 'University of Nebraska', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Won-mok son', 'investigatorAffiliation': 'Pusan National University'}}}}