Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-31 @ 5:20 AM
Study NCT ID:
NCT06724458
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2023-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Exercise Blood Flow Restriction
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': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum knee extension repetitions', 'timeFrame': 'From weeks two to three in the study', 'description': 'total repetitions completed for each load condition'}], 'secondaryOutcomes': [{'measure': 'Maximum barbell curl repetitions', 'timeFrame': 'From weeks two to three in the study', 'description': 'total repetitions completed for each load condition'}, {'measure': 'Change in vastus lateralis oxygen saturation', 'timeFrame': 'From weeks two to three in the study', 'description': 'The change in vastus lateralis oxygen saturation across each load condition'}, {'measure': 'Correlation of muscle fiber size/type/distribution to maximum knee extension repetitions at 20% 1RM', 'timeFrame': 'From weeks two to three in the study'}, {'measure': 'Correlation of mitochondrial content to maximum knee extension repetitions at 20% 1RM', 'timeFrame': 'From weeks two to three in the study'}, {'measure': 'Correlation of capillary density to maximum knee extension repetitions at 20% 1RM', 'timeFrame': 'From weeks two to three in the study'}, {'measure': 'Comparison of muscle fiber size/type/distribution, mitochondrial function, mitochondrial density, capillary density, absolute muscle size ,and VO2 max between participants of different training statuses', 'timeFrame': 'Week 3'}, {'measure': 'Correlation of absolute muscle size to maximum knee extension repetitions at 20% 1RM/barbell curl repetitions at 45% 1RM', 'timeFrame': 'Weeks 1, 2, and 3'}, {'measure': 'Correlation of absolute muscle size to maximum knee extension repetitions at 20% 1RM/barbell curl repetitions at 45% 1RM', 'timeFrame': 'Week 1'}, {'measure': 'Correlation of absolute muscle size to maximum knee extension repetitions at 20% 1RM/barbell curl repetitions at 45% 1RM', 'timeFrame': 'Week 2'}, {'measure': 'Comparison of absolute muscle size between sexes', 'timeFrame': 'Week 3'}, {'measure': 'Comparison of capillary density between sexes', 'timeFrame': 'Week 3'}, {'measure': 'Comparison of mitochondrial density between sexes', 'timeFrame': 'Week 3'}, {'measure': 'Comparison of muscle fiber distribution between sexes', 'timeFrame': 'Week 3'}, {'measure': 'Comparison of muscle fiber size between sexes', 'timeFrame': 'Week 3'}, {'measure': 'Comparison of muscle fiber type between sexes', 'timeFrame': 'Week 3'}, {'measure': 'Comparison of mitochondrial function between sexes', 'timeFrame': 'Week 3'}, {'measure': 'Comparison of VO2 max between sexes', 'timeFrame': 'Week 3'}, {'measure': 'Correlation of VO2 max to maximum knee extension repetitions at 20% 1RM', 'timeFrame': 'Week 1'}, {'measure': 'Correlation of VO2 max to maximum knee extension repetitions at 20% 1RM', 'timeFrame': 'Week 2'}, {'measure': 'Correlation of VO2 max to maximum knee extension repetitions at 20% 1RM', 'timeFrame': 'Week 3'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skeletal Muscle Endurance']}, 'descriptionModule': {'briefSummary': 'The number of repetitions able to be performed during resistance exercise is impacted by the load an individual is working against. Heavier loads lead to less repetitions being performed and lighter loads lead to more repetitions being performed. As the load gets progressively lighter, it is hypothesized that oxygen availability becomes an important factor for performance of maximum repetitions. Peripheral blood flow occlusion using exercise specific blood flow occlusion cuffs can allow for oxygen availability to be controlled by altering the amount of blood able to get to working muscles. To date, no study has examined the effect of varying exercise loads, from heavy to light, on maximum repetitions able to be performed with and without blood flow occlusion.', 'detailedDescription': 'The study aims to assess the difference in maximum repetitions performed at varying percentages of participants maximum strength and the impact peripheral blood flow occlusion has on performance\n\nThe study will take three weeks to complete with a total of six visits. The entire time commitment will be seven hours. During week 1 participants will visit the lab twice to perform baseline assessments of strength, endurance, muscle size and will also receive a resting thighs muscle biopsy. During weeks 2 and 3 participants will visit the lab twice per week to complete three out of twelve randomized exercise interventions per visit. The interventions are maximum repetitions at 80/40/30/25/20/15% of knee-extension one-repetition maximum as well as 90/70/60/55/50/45% of barbell curl one-repetition maximum; all of the listed conditions will be tested in a free-flow and blood flow occluded state (i.e., 12 total exercise interventions for the knee extension and 12 total exercise interventions for the barbell curl).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to understand and communicate in English\n2. 19-30 years of age\n3. All "No" answers on the Canadian Society for Exercise Physiology Get Active questionnaire or doctors\' approval to participate\n4. Untrained participants: no structured resistance and/or endurance training over the past 12-months (i.e., \\>2 hours per week of structured/periodized training)\n5. Resistance trained participants: structured resistance training over the past 12-months (i.e., \\>2 hours per week of structured/periodized resistance training)\n6. Endurance trained participants: structured resistance training over the past 12-months (i.e., \\>2 hours per week of structured/periodized endurance training)\n\nExclusion Criteria:\n\n1. BMI lower than 18 or greater than 30\n2. Current use of cigarettes or other nicotine devices\n3. Any major uncontrolled cardiovascular, muscular, metabolic, and/or neurological disorders\n4. Any medical condition impacting the ability to participate in maximal exercise\n5. Type one or type two diabetes\n6. Diagnosis of cancer or undergoing cancer treatment in the past 12 months\n7. Taking blood-thinning medication or the presence of a bleeding disorder\n8. Drug therapy with any drugs that alter skeletal muscle metabolism (i.e., Metformin, Benzodiazepines)\n9. Lowest calculated exercise testing load is less than the lightest weight able to be provided by the lab gymnasium equipment (i.e., 36 pounds for the knee extension, and/or 33 pounds for the barbell curl)'}, 'identificationModule': {'nctId': 'NCT06724458', 'acronym': 'BFRCL', 'briefTitle': 'Resistance Exercise Blood Flow Restriction', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Skeletal Muscle Endurance Responses to Various Relative Loads of Dynamic Resistance Exercise with and Without Peripheral Blood Flow Occlusion', 'orgStudyIdInfo': {'id': 'BFRCL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '80% knee extension/80% barbell curl 1RM', 'description': 'The load will be set to 80% of 1RM for the knee extension and 80% 1RM for the barbell curl', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '40% knee extension/70% barbell curl 1RM', 'description': 'The load will be set to 40% of 1RM for the knee extension and 70% 1RM for the barbell curl', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '30% knee extension/60% barbell curl 1RM', 'description': 'The load will be set to 30% of 1RM for the knee extension and 60% 1RM for the barbell curl', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '25% knee extension/55% barbell curl 1RM', 'description': 'The load will be set to 25% of 1RM for the knee extension and 55% 1RM for the barbell curl', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '20% knee extension/50% barbell curl 1RM', 'description': 'The load will be set to 25% of 1RM for the knee extension and 50% 1RM for the barbell curl', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '15% knee extension/45% barbell curl 1RM', 'description': 'The load will be set to 15% of 1RM for the knee extension and 45% 1RM for the barbell curl', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '80% knee extension/80% barbell curl 1RM both with blood flow occlusion', 'description': 'The load will be set to 80% of 1RM for the knee extension and 80% 1RM for the barbell curl with both being under peripheral blood flow occlusion', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '40% knee extension/60% barbell curl 1RM both with blood flow occlusion', 'description': 'The load will be set to 40% of 1RM for the knee extension and 60% 1RM for the barbell curl with both being under peripheral blood flow occlusion', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '30% knee extension/60% barbell curl 1RM both with blood flow occlusion', 'description': 'The load will be set to 30% of 1RM for the knee extension and 60% 1RM for the barbell curl with both being under peripheral blood flow occlusion', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '25% knee extension/55% barbell curl 1RM both with blood flow occlusion', 'description': 'The load will be set to 25% of 1RM for the knee extension and 55% 1RM for the barbell curl with both being under peripheral blood flow occlusion', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '20% knee extension/50% barbell curl 1RM both with blood flow occlusion', 'description': 'The load will be set to 20% of 1RM for the knee extension and 50% 1RM for the barbell curl with both being under peripheral blood flow occlusion', 'interventionNames': ['Other: Resistance exercise']}, {'type': 'EXPERIMENTAL', 'label': '15% knee extension/45% barbell curl 1RM both with blood flow occlusion', 'description': 'The load will be set to 15% of 1RM for the knee extension and 45% 1RM for the barbell curl with both being under peripheral blood flow occlusion', 'interventionNames': ['Other: Resistance exercise']}], 'interventions': [{'name': 'Resistance exercise', 'type': 'OTHER', 'description': 'All arms will involve participants performing resistance exercise bouts of the described exercises. at the given loads, and with the stated flow condition', 'armGroupLabels': ['15% knee extension/45% barbell curl 1RM', '15% knee extension/45% barbell curl 1RM both with blood flow occlusion', '20% knee extension/50% barbell curl 1RM', '20% knee extension/50% barbell curl 1RM both with blood flow occlusion', '25% knee extension/55% barbell curl 1RM', '25% knee extension/55% barbell curl 1RM both with blood flow occlusion', '30% knee extension/60% barbell curl 1RM', '30% knee extension/60% barbell curl 1RM both with blood flow occlusion', '40% knee extension/60% barbell curl 1RM both with blood flow occlusion', '40% knee extension/70% barbell curl 1RM', '80% knee extension/80% barbell curl 1RM', '80% knee extension/80% barbell curl 1RM both with blood flow occlusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 1Z3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Chan Gunn Pavilion', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'A plan has not yet been made to make individual participant data available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Cameron Mitchell', 'investigatorAffiliation': 'University of British Columbia'}}}}