Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 10:24 PM
Study NCT ID:
NCT05051306
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2021-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Resistance Exercise on Metabolic Responses
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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in glucose', 'timeFrame': '4-hour during each study intervention', 'description': 'glucose in mg/dL'}, {'measure': 'Changes in insulin', 'timeFrame': '4-hour during each study intervention', 'description': 'insulin in mU/L'}, {'measure': 'Changes in TG', 'timeFrame': '4-hour during each study intervention', 'description': 'TG mg/dL'}, {'measure': 'Changes in uric acid', 'timeFrame': '4-hour during each study intervention', 'description': 'uric acid mg/dL.'}], 'secondaryOutcomes': [{'measure': 'Changes in biomarkers of inflammation', 'timeFrame': '4-hour during each study intervention', 'description': 'Biomarkers of inflammation will be measured such as IL-10 in pg/mL and IL-6 in pg/mL.'}, {'measure': 'Changes in cortisol', 'timeFrame': '4-hour during each study intervention', 'description': 'cortisol in ng/mL'}, {'measure': 'Changes in lactate', 'timeFrame': '4-hour during each study intervention', 'description': 'lactate in mmol/L'}, {'measure': 'Changes in complete blood count', 'timeFrame': '4-hour during each study intervention', 'description': 'blood cell count in count per µL'}, {'measure': 'Borgs Ratings of Perceived Exertion (RPE)', 'timeFrame': '1-hour during each exercise intervention', 'description': 'Borgs RPE is a method of estimating exertion rating, based on a 6 to 20 rating scale (6 being the no exertion at all, 20 being maximal exertion).'}, {'measure': 'Changes in ET-1', 'timeFrame': '4-hour during each study intervention', 'description': 'ET-1 in pg/mL'}, {'measure': 'Changes in NO', 'timeFrame': '4-hour during each study intervention', 'description': 'NO in µmol/L'}, {'measure': 'Changes in biomarkers of muscle damage', 'timeFrame': '4-hour during each study intervention', 'description': 'Biomarkers of muscle damage will be measured such as CK in U/L and LDH in U/L.'}, {'measure': 'Heart rate (HR)', 'timeFrame': '6-hour during each study intervention', 'description': 'HR will be measured during each study intervention.'}, {'measure': 'Visual Analogue Scale (VAS) of appetite', 'timeFrame': '6-hour during each study intervention', 'description': 'Hunger, fullness, desire to eat, and prospective food consumption will be measured via VAS ratings, based on a 100 mm long scale (0 being "not at all", 100 being "extremely").'}, {'measure': 'Changes in biomarkers of appetite', 'timeFrame': '4-hour during each study intervention', 'description': 'Biomarkers of appetite will be measured such as ghrelin in pg/mL and PYY in pg/mL.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['resistance exercise', 'equal training volume', 'immune response'], 'conditions': ['Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'Healthy young adults will complete three trials in a randomized crossover counter-balanced order, including two different loads of resistance exercise and sedentary control. During each trial, blood samples will be collected.\n\nThe investigators hypothesized that high-load and low-load resistance exercise exert similar metabolic responses.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20-30\n* Healthy male\n* Without experience of resistance training\n\nExclusion Criteria:\n\n* No acute or chronic musculoskeletal symptoms\n* Smoking\n* Alcohol or drug abuse\n* Fail to conduct resistance exercise'}, 'identificationModule': {'nctId': 'NCT05051306', 'briefTitle': 'Effects of Resistance Exercise on Metabolic Responses', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan Normal University'}, 'officialTitle': 'Effects of Volume-matched Resistance Exercise With Different Loads on Metabolic Responses', 'orgStudyIdInfo': {'id': '202011HM005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-load resistance exercise', 'description': '4 high-load resistance exercises that target all major muscle groups.', 'interventionNames': ['Other: High-load resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Low-load resistance exercise', 'description': '4 low-load resistance exercises that target all major muscle groups.', 'interventionNames': ['Other: Low-load resistance exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Sedentary control', 'description': 'Subjects in control trial stayed sedentary during the period.'}], 'interventions': [{'name': 'High-load resistance exercise', 'type': 'OTHER', 'description': 'Subjects in high-load trial performed 4 sets per exercise, 8 repetitions with load of 85%-8RM with 90 sec of rest between sets.', 'armGroupLabels': ['High-load resistance exercise']}, {'name': 'Low-load resistance exercise', 'type': 'OTHER', 'description': 'Subjects in low-load trial performed 4 sets per exercise, 15 repetitions with load of 45%-8RM with 90 sec of rest between sets.', 'armGroupLabels': ['Low-load resistance exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '162', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan Normal University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Hung-Wen Liu, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan Normal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}