Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT05042167
Status:
COMPLETED
Last Update Posted:
2023-01-13
First Post:
2021-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Resistance Exercise on Inflammation in Young and Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in biomarkers of inflammation', 'timeFrame': '24-hour during each study intervention', 'description': 'Biomarkers of inflammation will be measured such as IL-10 in pg/mL, IL-6 in pg/mL, TNF-α in pg/mL.'}], 'secondaryOutcomes': [{'measure': 'Changes in glucose', 'timeFrame': '24-hour during each study intervention', 'description': 'glucose in mg/dL'}, {'measure': 'Changes in metabolic parameters', 'timeFrame': '24-hour during each study intervention', 'description': 'Metabolic parameters will be measured such as TC in mg/dL, TG in mg/dL, and HDL in mg/dL.'}, {'measure': 'Changes in biomarkers of muscle damage', 'timeFrame': '24-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': 'Changes in molecular markers in peripheral blood mononuclear cells (PBMC)', 'timeFrame': '24-hour during each study intervention', 'description': 'Molecular markers in PBMC will be measured such as STAT3 in arbitrary units, IKK in arbitrary units, IkB in arbitrary units, p65 in arbitrary units, SOCS3 in arbitrary units, AMPK in arbitrary units, and SIRT1 in arbitrary units.'}, {'measure': 'Changes in complete blood count (CBC)', 'timeFrame': '24-hour during each study intervention', 'description': 'The white blood cell count and the count of each white blood cell type will be measured.'}, {'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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging', 'Inflammatory Response']}, 'referencesModule': {'references': [{'pmid': '39475859', 'type': 'DERIVED', 'citation': 'Tsai SH, Cheng HC, Little JP, Islam H, Liu HW. Elevated Plasma IL-6 Coincides with Activation of STAT3 in PBMC After Acute Resistance Exercise. Med Sci Sports Exerc. 2024 Nov 1;56(11):2117-2124. doi: 10.1249/MSS.0000000000003503.'}]}, 'descriptionModule': {'briefSummary': 'Healthy young and older adults will complete two trials in a randomized crossover counter-balanced order, including resistance exercise and sedentary control. During each trial, blood samples will be collected.\n\nThe investigators hypothesized that an acute bout of resistance exercise exert different inflammation responses in young and older adults.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20-80\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': 'NCT05042167', 'briefTitle': 'The Effect of Resistance Exercise on Inflammation in Young and Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan Normal University'}, 'officialTitle': 'The Acute Effect of High-load Resistance Exercise on Inflammation in Young and Older Adults', 'orgStudyIdInfo': {'id': '202012HM020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-load resistance exercise', 'description': 'Subjects in high-load trial performed 3 sets per exercise, 8 repetitions with load of 70%-1RM with 90 sec of rest between sets, followed by a fourth set to voluntary failure.', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Sedentary control', 'description': 'Subjects in control trial stayed sedentary during the period.'}], 'interventions': [{'name': 'Resistance exercise', 'type': 'OTHER', 'description': '4 total resistance exercises that target all major muscle groups.', 'armGroupLabels': ['High-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'}}}}