Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT03300895
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2017-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-intensity Interval Training on Cardiorespiratory Fitness in Overweight Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'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': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in maximal oxygen consumption', 'timeFrame': 'Baseline and after 10 weeks', 'description': 'Maximal oxygen consumption will be obtained using a graded exercise test on a treadmill (Trackmaster® model TMX 425C) using a portable K4b2 gas analyzer (Cosmed Inc., IL, USA)'}], 'secondaryOutcomes': [{'measure': 'Change in total body fat', 'timeFrame': 'Baseline and after 10 weeks', 'description': 'Total body fat will be obtained using an Omron® HBF-510 (Omron Healthcare, Inc. Bannockburn, IL, USA) bioelectrical impedance machine.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '35228846', 'type': 'DERIVED', 'citation': 'Arboleda-Serna VH, Patino-Villada FA, Pinzon-Castro DA, Arango-Velez EF. Effects of low-volume, high-intensity interval training on maximal oxygen consumption, body fat percentage and health-related quality of life in women with overweight: A randomized controlled trial. J Exerc Sci Fit. 2022 Apr;20(2):108-112. doi: 10.1016/j.jesf.2022.01.004. Epub 2022 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'High-intensity interval training (HIIT) is currently considered one of the most effective strategies to improved cardiorespiratory fitness, which is recognized as a protective factor for cardiovascular diseases and metabolic diseases such as overweight and obesity. However, current evidence is still limited and requires clarity (frequency, time per session and intensity) regarding to greater increases attributed to HIIT.\n\nThe aim of this study is to compare the effect of a low-volume high-intensity interval training versus a moderate-intensity continuous exercise on maximal oxygen consumption in overweight women 18 to 44 years old.', 'detailedDescription': 'Thirty-six women will be randomly assigned to one of two aerobic exercise on a real-life setting supervised for a physical activity instructor. The interventions will performed three times a week for ten-weeks (on alternate days).\n\nThe first two weeks will correspond to the conditioning period (30 minutes between 55-65% of maximum heart rate (HRmax). From week three, 18 participants will perform 30 minutes of continuous exercise at an intensity between 65-75 % of HRmax, and the remaining 18 will complete 21.5 minutes of interval exercise at an intensity between 90-95% of HRmax, with recoveries between 50-55% of HRmax.\n\nAll Participants will be evaluated to measure their maximal oxygen consumption, total body fat, waist circumference, body mass index, systolic blood pressure, diastolic blood pressure, prior to start the interventions and at the end of the program (week 11).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight (≥ 25 kg/m-2) women 18 to 44 years.\n* Healthy volunteers.\n* Perform ≤ 600 Met/min/week.\n\nExclusion Criteria:\n\n* Perform high-intensity interval exercise in the last six month.\n* Smoker.\n* History of asthma.\n* History of diabetes.\n* History of hypertension.\n* History of cardiovascular disease.\n* History of coronary heart disease.\n* Arrhythmias.\n* Personal history of surgical procedures in the last three months\n* Uncontrolled non-communicable diseases\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.\n* Psychoactive drug abuse.'}, 'identificationModule': {'nctId': 'NCT03300895', 'briefTitle': 'High-intensity Interval Training on Cardiorespiratory Fitness in Overweight Women', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Antioquia'}, 'officialTitle': 'Effect of Low-volume High-intensity Interval Training on Cardiorespiratory Fitness and Total Body Fat in Overweight Women', 'orgStudyIdInfo': {'id': 'HIIT2-AFIS-UdeA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-intensity interval training', 'interventionNames': ['Other: High-intensity interval training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate-intensity continuous exercise', 'interventionNames': ['Other: Comparator: Moderate-intensity continuous exercise']}], 'interventions': [{'name': 'High-intensity interval training', 'type': 'OTHER', 'description': '21.5 minutes of high-intensity interval exercise at an intensity between 90-95 of HRmax (15x30 s), with recoveries at 50-60% of HRmax (14x60 s). 24 sessions, 3x weekly of walking and running outdoors on a sports field in a supervised manner.', 'armGroupLabels': ['High-intensity interval training']}, {'name': 'Comparator: Moderate-intensity continuous exercise', 'type': 'OTHER', 'description': '30 minutes of continuous exercise at an intensity between 65-75% of HRmax. 24 sessions, 3x weekly of walking and jogging outdoors on a sports field in a supervised manner', 'armGroupLabels': ['Moderate-intensity continuous exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Universidad de Antioquia', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Antioquia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, MSc', 'investigatorFullName': 'Victor Hugo Arboleda Serna', 'investigatorAffiliation': 'Universidad de Antioquia'}}}}