Viewing Study NCT02288403


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Study NCT ID: NCT02288403
Status: COMPLETED
Last Update Posted: 2016-06-24
First Post: 2014-11-04
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Interval Versus Continuous Training in Healthy Adults
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-22', 'studyFirstSubmitDate': '2014-11-04', 'studyFirstSubmitQcDate': '2014-11-06', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in maximal oxygen uptake', 'timeFrame': 'Baseline and 8-weeks'}], 'secondaryOutcomes': [{'measure': 'Change in systolic blood pressure', 'timeFrame': 'Baseline and 8-weeks'}, {'measure': 'Change in diastolic blood pressure', 'timeFrame': 'Baseline and 8-weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aerobic Exercise', 'Oxygen Consumption', 'Blood Pressure'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '31584766', 'type': 'DERIVED', 'citation': 'Arboleda-Serna VH, Feito Y, Patino-Villada FA, Vargas-Romero AV, Arango-Velez EF. Effects of high-intensity interval training compared to moderate-intensity continuous training on maximal oxygen consumption and blood pressure in healthy men: A randomized controlled trial. Biomedica. 2019 Sep 1;39(3):524-536. doi: 10.7705/biomedica.4451.'}, {'pmid': '27538896', 'type': 'DERIVED', 'citation': 'Arboleda Serna VH, Arango Velez EF, Gomez Arias RD, Feito Y. Effects of a high-intensity interval training program versus a moderate-intensity continuous training program on maximal oxygen uptake and blood pressure in healthy adults: study protocol for a randomized controlled trial. Trials. 2016 Aug 18;17:413. doi: 10.1186/s13063-016-1522-y.'}]}, 'descriptionModule': {'briefSummary': 'Aerobic exercise produces increases in cardiorespiratory fitness (CF), which constitute a protective factor for cardiovascular disease and all-cause mortality. Therefore, aerobic exercise is a key strategy to promoting cardiovascular. There is some evidence that aerobic high intensity interval training may lead to greater increases in CF compared with continuous moderate-intensity training.\n\nThe main objective of this study is to examine the effects of an aerobic high intensity training program versus a continuous moderate intensity training program on CF in men 18 to 44 years.', 'detailedDescription': 'Forty-four individuals will be randomly assigned to one of two aerobic training programs on a treadmill. Both groups will performed three times a week for eight-weeks (on alternate days). Half will run 40 minutes of continuous exercise at an intensity between 65-75% of maximum heart rate, and the remaining 22 will complete 21.5 minutes of interval exercise at an intensity between 90-95% of maximum heart rate, with recoveries between 50-55 % of maximum heart rate. After each session both groups will complete eight strength exercises mainly including large muscle groups for two sets and 8-12 repetitions at an intensity equivalent to 60-70% of one repetition maximum (controlled by perceived effort). Rest between sets will be kept between 60 and 90 seconds.\n\nAll participants will be evaluated at the start and completion of the intervention for their maximal oxygen consumption, blood pressure, waist circumference, BMI, body composition, and steps per week.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Perform aerobic exercise maximum 3 sessions per week\n\nExclusion Criteria:\n\n* Currently participating in an aerobic high intensity training program\n* Smoker\n* History of cardiovascular disease\n* History of coronary heart disease\n* Arrhythmias\n* Heart failure/insufficiency\n* Hypertension\n* Diabetes\n* Under medical treatment with anticoagulants, beta-blockers, calcium antagonists, bronchodilators, and/or steroids\n* Psychological, neuromotor and/or osteo-muscular conditions that may affect participation in an exercise program.'}, 'identificationModule': {'nctId': 'NCT02288403', 'briefTitle': 'Interval Versus Continuous Training in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Antioquia'}, 'officialTitle': 'Effects of a High-intensity Interval Training Program Compared to a Moderate Intensity Program in Adults 18-44 Years', 'orgStudyIdInfo': {'id': 'HIIT-1-UdeA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic interval training', 'description': 'Interval exercise at an intensity between 90-95% of maximum heart rate (15x30 s), with recoveries at an equivalent speed to 50-55 % of maximal oxygen consumption at baseline (14x60 s).\n\n24 training sessions, 3x weekly (on alternate days).', 'interventionNames': ['Behavioral: Aerobic interval training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous training', 'description': '40 minutes of continuous exercise at an intensity between 65-75% of maximum heart rate.\n\n24 training sessions, 3x weekly (on alternate days).', 'interventionNames': ['Behavioral: Continuous training']}], 'interventions': [{'name': 'Aerobic interval training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Aerobic interval training']}, {'name': 'Continuous training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Continuous training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Universidad de Antioquia', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'overallOfficials': [{'name': 'Víctor H Arboleda, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}, {'name': 'Elkin F Arango, MD. MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}, {'name': 'Rubén D Gómez, PhD. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}, {'name': 'Yuri Feito, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Antioquia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Victor Hugo Arboleda Serna', 'investigatorAffiliation': 'Universidad de Antioquia'}}}}