Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-30 @ 7:19 AM
Study NCT ID:
NCT05092061
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Training in Adults With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will consist of both a crossover study model (acute phase) and parallel model (chronic phase).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated haemoglobin (HbA1c)', 'timeFrame': '7 weeks'}], 'secondaryOutcomes': [{'measure': 'Fasting glucose', 'timeFrame': '7 weeks'}, {'measure': 'Blood lipid concentration', 'timeFrame': '7 weeks'}, {'measure': 'C-reactive protein', 'timeFrame': '7 weeks'}, {'measure': 'Systolic blood pressure', 'timeFrame': '7 weeks'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '7 weeks'}, {'measure': 'Body fat', 'timeFrame': '7 weeks', 'description': 'Measured by bioelectrical impedance (InBody 770)'}, {'measure': 'Fat-free mass', 'timeFrame': '7 weeks', 'description': 'Measured by bioelectrical impedance (InBody 770)'}, {'measure': 'Body mass', 'timeFrame': '7 weeks', 'description': 'Measured by bioelectrical impedance (InBody 770)'}, {'measure': 'Visceral fat area', 'timeFrame': '7 weeks', 'description': 'Measured by bioelectrical impedance (InBody 770)'}, {'measure': 'Waist circumference', 'timeFrame': '7 weeks'}, {'measure': 'VO2max (maximal aerobic capacity)', 'timeFrame': '7 weeks'}, {'measure': 'Rate of force development', 'timeFrame': '7 weeks', 'description': 'Measured by Kistler force plate'}, {'measure': 'Muscular strength (1RM)', 'timeFrame': '7 weeks', 'description': 'Leg press and bench press'}, {'measure': 'Muscular endurance', 'timeFrame': '7 weeks', 'description': 'Maximum number of repetitions using 50% of 1-RM'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline (before intervention), 4 and 7 weeks.', 'description': 'Assessed at three timepoints throughout the intervention using SenseWear armband activity monitors and/or Personal Activity IntelligenceTM (using heart rate monitors and smart phone application).'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '7 weeks', 'description': 'Using the Short-Form 36 survey and Satisfaction with Physical Function and Appearance Survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise therapy', 'Muscular strength', 'Resistance training', 'Fitness testing', 'Healthy lifestyle'], 'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is two-fold: (1) to assess if two different resistance training protocols elicit different responses in the acute phase and (2) to assess if the same two different protocols will elicit different long-term responses on muscular strength, body composition and cardiometabolic health. The project will include 30 adults with obesity (defined as BMI ≥ 30 or abdominal obesity according to the International Diabetes Federation). In the acute phase blood lactate, heart rate, enjoyment and perceived exertion will be assessed after the two resistance training protocols. In addition, the mean 24-h blood glucose concentration after exercise will be compared between the two protocols.\n\nFor the long-term effects blood markers of cardiometabolic health, blood pressure, body composition, objectively measured physical activity and physical fitness will be assessed before and after the intervention. Also, perceived health-related quality of life will be assessed before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity (BMI ≥ 30) or\n* Central obesity (defined according to the International Diabetes Federation).\n\nExclusion Criteria:\n\n* Unstable angina\n* recent cardiac infarction (last 4 weeks)\n* uncompensated heart failure\n* severe valvular illness\n* pulmonary disease\n* uncontrolled hypertension\n* kidney failure\n* orthopaedic/neurological limitations\n* cardiomyopathy\n* planned operations during the research period\n* participation in a parallel study'}, 'identificationModule': {'nctId': 'NCT05092061', 'briefTitle': 'Resistance Training in Adults With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Acute and Chronic Effects of Two Different Types of Resistance Training on Cardiometabolic Health in Adults With Obesity', 'orgStudyIdInfo': {'id': '246888'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate-repetition resistance training', 'description': 'The participants will undergo a full-body resistance training protocol with moderate repetitions (6-12), moderate load (70-85% of 1RM), and moderate rest between sets (60-90s). Training will be undertaken three times per week.', 'interventionNames': ['Other: Moderate-repetition resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'High-repetition resistance training', 'description': 'The participants will undergo a full-body resistance training protocol with high repetitions (15+), low load (\\<60% of 1RM), and short rest between sets (30s). Training will be undertaken three times per week.', 'interventionNames': ['Other: High-repetition resistance training']}], 'interventions': [{'name': 'Moderate-repetition resistance training', 'type': 'OTHER', 'description': 'Will undertake resistance training with moderate loads, and moderate repetitions 3 times per week for 7 weeks.', 'armGroupLabels': ['Moderate-repetition resistance training']}, {'name': 'High-repetition resistance training', 'type': 'OTHER', 'description': 'Will undertake resistance training with low loads, and high repetitions 3 times per week for 7 weeks.', 'armGroupLabels': ['High-repetition resistance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7491', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of Circulation and Medical Imaging', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Øystein Risa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}