Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT04151095
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2019-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining The Effect of Blood Flow Restricted Aerobic Training on Mitochondrial Adaptations in Young 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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Allocation concealment, assessor blinding'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Citrate Synthase', 'timeFrame': '3 days prior to start of exercise training and 3 days after completing exercise training', 'description': 'Fold change in citrate synthase maximal activity'}], 'secondaryOutcomes': [{'measure': 'Transcription factor A, mitochondrial (TFAM)', 'timeFrame': '3 days before training to 3 days after training', 'description': 'Fold change in TFAM protein'}, {'measure': 'Nuclear respiratory factor, 1 (NRF1)', 'timeFrame': '3 days before training to 3 days after training', 'description': 'Fold change in NRF-1 protein'}, {'measure': 'Maximal oxygen consumption (VO2peak)', 'timeFrame': '3 days before training to 3 days after training', 'description': 'Change in VO2peak (POST-PRE)'}, {'measure': 'Heart rate (HR)', 'timeFrame': 'Every 5 minutes during each of the 7, 30-minute exercise sessions', 'description': 'Average HR'}, {'measure': 'Revolutions per minute (RPM)', 'timeFrame': 'Every 5 minutes during each of the 7, 30-minute exercise sessions', 'description': 'Average RPM'}, {'measure': 'Blood [lactate]', 'timeFrame': 'During all exercise sessions at 10 and 30 minutes', 'description': 'Average blood lactate concentration'}, {'measure': 'Rating of perceived exertion (RPE)', 'timeFrame': 'Every 5 minutes during each of the 7, 30-minute exercise sessions', 'description': 'Average RPE'}, {'measure': 'Nuclear Factor, Erythroid 2 Like 2 (NFE2L2)', 'timeFrame': '3 days before training to 3 days after training', 'description': 'Fold change in NFE2L2'}, {'measure': 'Cytochrome c oxidase (COX)', 'timeFrame': '3 days before training to 3 days after training', 'description': 'Fold change in COX'}, {'measure': 'Electromyography (EMG)', 'timeFrame': 'Throughout each of the 7, 30-minute exercise sessions', 'description': 'Median frequency and average amplitude of EMG signal'}, {'measure': 'Near-infrared spectroscopy (NIRS)', 'timeFrame': 'Throughout each of the 7, 30-minute exercise sessions', 'description': 'Deoxygenated hemoglobin and oxygenated hemoglobin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mitochondria', 'Exercise training', 'VO2', 'Aerobic exercise', 'Citrate Synthase', 'Blood flow restriction'], 'conditions': ['Mitochondrial Biogenesis']}, 'referencesModule': {'references': [{'pmid': '40224168', 'type': 'DERIVED', 'citation': 'Preobrazenski N, Mladen SPS, Causer E, Menezes E, Islam H, Drouin PJ, Tschakovsky ME, Gurd BJ. Mitochondrial and cardiovascular responses to aerobic exercise training in supine and upright positions in healthy young adults: a randomized parallel arm trial. Transl Exerc Biomed. 2025 Mar 26;2(1):9-20. doi: 10.1515/teb-2025-0002. eCollection 2025 May.'}]}, 'descriptionModule': {'briefSummary': 'This parallel-arm trial study investigates the effects of restricting arterial blood flow during cycling exercise on citrate synthase. Participants will be randomized to either a blood flow restricted or non-blood flow restricted exercise training group. Both groups will complete seven, 30-minute exercise sessions over a 14-day period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3 hours of physical activity per week\n* No previous cycling training\n* No concurrent involvement in another training program\n* Body mass index \\< 30 kg/m2\n\nExclusion Criteria:\n\n* Presence of cardiovascular disease\n* Presence of metabolic disease\n* Taking regular oral medication\n* Current smoker'}, 'identificationModule': {'nctId': 'NCT04151095', 'briefTitle': 'Examining The Effect of Blood Flow Restricted Aerobic Training on Mitochondrial Adaptations in Young Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Examining The Effect of Blood Flow Restricted Aerobic Training on Citrate Synthase Activity in Young Healthy Adults', 'orgStudyIdInfo': {'id': 'BFRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BFR', 'interventionNames': ['Other: BFR Exercise Training']}, {'type': 'EXPERIMENTAL', 'label': 'CTL', 'interventionNames': ['Other: CTL Exercise Training']}], 'interventions': [{'name': 'BFR Exercise Training', 'type': 'OTHER', 'description': 'Participants will complete exercise training on a recumbent bike placed on a 45 degree incline (BFR).', 'armGroupLabels': ['BFR']}, {'name': 'CTL Exercise Training', 'type': 'OTHER', 'description': 'Participants will complete exercise training on a recumbent bike placed on flat ground (CTL).', 'armGroupLabels': ['CTL']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L3N6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Brendon J Gurd, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brendon Gurd, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brendon Gurd, PhD', 'investigatorAffiliation': "Queen's University"}}}}