Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT03984994
Status:
COMPLETED
Last Update Posted:
2025-10-29
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Muscle Capillarization and Sarcopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sprior@umd.edu', 'phone': '301-405-2483', 'title': 'Dr. Steven J. Prior', 'organization': 'University of Maryland'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data were collected over 6 months of study participation', 'description': 'The study adhered to clinicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Aerobic Exercise Training Followed by Resistance Training', 'description': 'Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Resistance Training Followed by Aerobic Exercise Training', 'description': 'Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skeletal Muscle Capillarization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerobic Exercise Training Followed by Resistance Training', 'description': 'Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}, {'id': 'OG001', 'title': 'Resistance Training Followed by Aerobic Exercise Training', 'description': 'Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2', 'groupDescription': 'Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.\n\nThe hypothesis was that the "Aerobic exercise training followed by resistance training" arm would have greater changes/improvements in study outcomes than the "Resistance training followed by aerobic training" group.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months (post minus pre-resistance training)', 'description': 'Change in the number of capillaries per unit of skeletal muscle tissue after resistance training. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.', 'unitOfMeasure': 'capillaries per muscle fiber', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completing the resistance training portion of the intervention in each arm were analyzed. Only data for the resistance training portion of the study are reported (change post-pre training). Data and analyses are not reported for aerobic exercise as this was not part of the aims/outcomes and was only assessed to gauge responses to only RT.'}, {'type': 'PRIMARY', 'title': 'Quadriceps Muscle Cross-sectional Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerobic Exercise Training Followed by Resistance Training', 'description': 'Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}, {'id': 'OG001', 'title': 'Resistance Training Followed by Aerobic Exercise Training', 'description': 'Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.8', 'groupDescription': 'Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.\n\nThe hypothesis was that the "Aerobic exercise training followed by resistance training" arm would have greater changes/improvements in study outcomes than the "Resistance training followed by aerobic training" group.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months (post minus pre-resistance training)', 'description': 'Change in the size of the thigh muscles. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.', 'unitOfMeasure': 'square centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completing the resistance training portion of the intervention in each arm were analyzed. Only data for the resistance training portion of the study are reported (change post-pre training). Data and analyses are not reported for aerobic exercise as this was not part of the aims/outcomes and was only assessed to gauge responses to only RT.'}, {'type': 'SECONDARY', 'title': 'Skeletal Muscle Fiber Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerobic Exercise Training Followed by Resistance Training', 'description': 'Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}, {'id': 'OG001', 'title': 'Resistance Training Followed by Aerobic Exercise Training', 'description': 'Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}], 'classes': [{'categories': [{'measurements': [{'value': '607', 'spread': '108', 'groupId': 'OG000'}, {'value': '356', 'spread': '227', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '251', 'groupDescription': 'Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.\n\nThe hypothesis was that the "Aerobic exercise training followed by resistance training" arm would have greater changes/improvements in study outcomes than the "Resistance training followed by aerobic training" group.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months (post minus pre-resistance training)', 'description': 'Change in the cross-sectional size of individual thigh skeletal muscle fibers. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.', 'unitOfMeasure': 'square micrometers', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completing the resistance training portion of the intervention in each arm were analyzed. Only data for the resistance training portion of the study are reported (change post-pre training). Data and analyses are not reported for aerobic exercise as this was not part of the aims/outcomes and was only assessed to gauge responses to only RT.'}, {'type': 'SECONDARY', 'title': 'Muscle Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerobic Exercise Training Followed by Resistance Training', 'description': 'Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}, {'id': 'OG001', 'title': 'Resistance Training Followed by Aerobic Exercise Training', 'description': 'Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '10.7', 'groupDescription': 'Per the aims of the study, the responses to RT were compared between 2 arms/groups. The change in the outcome (post-RT minus pre-RT) in each arm/group was compared using a t-test. Responses to AEX training itself are not assessed as this was not an aim or hypothesis of the study.\n\nThe hypothesis was that the "Aerobic exercise training followed by resistance training" arm would have greater changes/improvements in study outcomes than the "Resistance training followed by aerobic training" group.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months (post minus pre-resistance training)', 'description': 'Change in the strength/force produced by skeletal muscles of the thigh. Only the resistance training-induced change (post minus pre-resistance training) is reported as this is the primary outcome for each arm.', 'unitOfMeasure': 'Newton-meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completing the resistance training portion of the intervention in each arm were analyzed. Only data for the resistance training portion of the study are reported (change post-pre training). Data and analyses are not reported for aerobic exercise as this was not part of the aims/outcomes and was only assessed to gauge responses to only RT.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aerobic Exercise Training Followed by Resistance Training', 'description': 'Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}, {'id': 'FG001', 'title': 'Resistance Training Followed by Aerobic Exercise Training', 'description': 'Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants are assigned to groups upon completion of baseline testing.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aerobic Exercise Training Followed by Resistance Training', 'description': 'Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}, {'id': 'BG001', 'title': 'Resistance Training Followed by Aerobic Exercise Training', 'description': 'Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training\n\nAerobic exercise training: 3 months of center-based, supervised treadmill exercise\n\nStrength training: 3 months of center-based, supervise strength training'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '4', 'groupId': 'BG000'}, {'value': '73', 'spread': '6', 'groupId': 'BG001'}, {'value': '75', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Appendicular Lean Mass (kg)', 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '19.3', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '18.4', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quadriceps muscle strength (Newton*meters)', 'classes': [{'categories': [{'measurements': [{'value': '91', 'spread': '15', 'groupId': 'BG000'}, {'value': '107', 'spread': '30', 'groupId': 'BG001'}, {'value': '101', 'spread': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Newton*meters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants assigned to an intervention are included.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-22', 'size': 110351, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-15T07:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study employs 2 interventions: resistance training and aerobic exercise training. One group of participants will undergo resistance training then aerobic exercise training; the other group will undergo aerobic exercise training then resistance training.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2019-06-05', 'resultsFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2019-06-12', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-15', 'studyFirstPostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skeletal Muscle Capillarization', 'timeFrame': '3 months (post minus pre-resistance training)', 'description': 'Change in the number of capillaries per unit of skeletal muscle tissue after resistance training. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.'}, {'measure': 'Quadriceps Muscle Cross-sectional Area', 'timeFrame': '3 months (post minus pre-resistance training)', 'description': 'Change in the size of the thigh muscles. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.'}], 'secondaryOutcomes': [{'measure': 'Skeletal Muscle Fiber Size', 'timeFrame': '3 months (post minus pre-resistance training)', 'description': 'Change in the cross-sectional size of individual thigh skeletal muscle fibers. The aims of the study were to compare responses to resistance training between arms/groups. Therefore, only the resistance training-induced change (post minus pre-resistance training) is assessed and analyzed as this is the primary outcome for each arm.'}, {'measure': 'Muscle Strength', 'timeFrame': '3 months (post minus pre-resistance training)', 'description': 'Change in the strength/force produced by skeletal muscles of the thigh. Only the resistance training-induced change (post minus pre-resistance training) is reported as this is the primary outcome for each arm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['muscle', 'capillary', 'exercise'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'Aging is associated with a loss of muscle mass, termed sarcopenia, that reduces mobility, decreases physical function and accelerates progression of other age-related disorders. This study is designed to determine whether increasing skeletal muscle capillarization through aerobic exercise will enhance muscular adaptations to strength training in older adults with sarcopenia.', 'detailedDescription': 'Sarcopenia, or the aging-related loss of muscle mass, affects a large number of older adults. The presence of sarcopenia is associated with physical disability, poor quality of life, and all-cause mortality, in part because sarcopenic adults have low muscle skeletal muscle capillarization and may lack the adequate perfusion needed to maintain muscle mass and function. This study will test the effects of increasing skeletal muscle capillarization through aerobic exercise training on responses to resistance training in older adults. Eligible participants will be randomized to one of two groups, resistance training preceded by aerobic exercise training (AEX-RT), or resistance training followed by aerobic exercise training (RT-AEX). Participants in the AEX-RT group will undergo 3 months of aerobic exercise training to increase skeletal muscle capillarization, followed by 3 months of resistance training. Participants in the RT-AEX group will undergo 3 months of resistance training, followed by 3 months of aerobic exercise training. Before and after the interventions, participants will undergo assessments of muscle size, strength, and capillarization, as well as assessments of physical function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index = 18-32.5 kg/m2\n* Non-smoker\n* Presence of at least moderate sarcopenia (low muscle mass per unit body height)\n\nExclusion Criteria:\n\n* Diagnosis of diabetes, cancer, pulmonary or renal disease\n* Physical impairment preventing exercise\n* Recent history of exercise training'}, 'identificationModule': {'nctId': 'NCT03984994', 'briefTitle': 'Muscle Capillarization and Sarcopenia', 'organization': {'class': 'FED', 'fullName': 'Baltimore VA Medical Center'}, 'officialTitle': 'Increasing Muscle Capillarization to Enhance Responses to Strength Training in Sarcopenia', 'orgStudyIdInfo': {'id': 'HP-00086001'}, 'secondaryIdInfos': [{'id': '5R21AG064571', 'link': 'https://reporter.nih.gov/quickSearch/5R21AG064571', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise training followed by resistance training', 'description': 'Participants in this arm will undergo 3 months of aerobic exercise training, followed by 3 months of strength training', 'interventionNames': ['Other: Aerobic exercise training', 'Other: Strength training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Resistance training followed by aerobic exercise training', 'description': 'Participants in this arm will undergo 3 months of strength training, followed by 3 months of aerobic exercise training', 'interventionNames': ['Other: Aerobic exercise training', 'Other: Strength training']}], 'interventions': [{'name': 'Aerobic exercise training', 'type': 'OTHER', 'description': '3 months of center-based, supervised treadmill exercise', 'armGroupLabels': ['Aerobic exercise training followed by resistance training', 'Resistance training followed by aerobic exercise training']}, {'name': 'Strength training', 'type': 'OTHER', 'description': '3 months of center-based, supervise strength training', 'armGroupLabels': ['Aerobic exercise training followed by resistance training', 'Resistance training followed by aerobic exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, Baltimore & Baltimore VA Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20742', 'city': 'College Park', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 38.98067, 'lon': -76.93692}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baltimore VA Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Steven J. Prior, Ph.D.', 'investigatorAffiliation': 'University of Maryland, College Park'}}}}