Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-25 @ 5:06 AM
Study NCT ID:
NCT02775760
Status:
TERMINATED
Last Update Posted:
2023-05-10
First Post:
2016-05-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Entorhinal Cortex and Aerobic Exercise in Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D065854', 'term': 'Spatial Navigation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013037', 'term': 'Spatial Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018583', 'term': 'Pliability'}], 'ancestors': [{'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kschon@bu.edu', 'phone': '(617) 358-2118', 'title': 'Karin Schon, Ph.D.', 'organization': 'Boston University Chobanian & Avedisian School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Note the small number of participants with complete pre- and post-intervention datasets (N=19). This number was even lower for functional MRI data analyses due to excessive head motion. This limits the interpretation of the results. In addition, the trial was also suspended and then terminated due to the SARS-CoV-2 (COVID-19) pandemic, which also contributed to data loss.'}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity\n\nCardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 3, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.\n\nStrength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'hip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Concussion', 'notes': "Unrelated to research study (due to accident that happened at participant's home)", 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone fracture', 'notes': 'right foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tachycardia and chest tightness', 'notes': 'EMT suspected heart rate monitor dysfunction and a subsequent panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fainting', 'notes': '1 participant reported being admitted to an emergency department due to fainting spells', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sciatica pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden tachycardia', 'notes': 'Participant was subsequently diagnosed with atrial fibrillation (no hospitalization needed), and participation was terminated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Functional MRI - Right Subiculum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity\n\nCardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center'}, {'id': 'OG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.\n\nStrength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07876229', 'spread': '0.233351521', 'groupId': 'OG000'}, {'value': '-0.14511014', 'spread': '0.141012355', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 months-baseline (pre-intervention)', 'description': 'The fMRI is measuring blood oxygenation levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. This measurement was obtained while participants were performing a virtual navigation task in the MRI scanner.\n\nData reported for fMRI is in beta-weight for navigation greater control contrast of BOLD images. The beta-weight is a standardized regression coefficient. Higher beta-weights mean greater activation and lower beta-weights mean less activation in specific brain regions being monitored. Negative beta-weights mean lower activation for the navigation condition than for the control condition, positive beta-weights mean greater activation for the navigation condition than for the control condition.', 'unitOfMeasure': 'BOLD Signal (beta weight)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants were excluded due to excess head motion during functional MRI (2 RT, 1 ET), 1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training, RT = resistance training)'}, {'type': 'PRIMARY', 'title': 'Structural MRI - Right Dentate Gyrus Head', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity\n\nCardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center'}, {'id': 'OG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.\n\nStrength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center'}], 'classes': [{'categories': [{'measurements': [{'value': '142.7478413', 'spread': '14.36877697', 'groupId': 'OG000'}, {'value': '137.1801957', 'spread': '19.71149913', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 months-baseline (pre-intervention)', 'description': 'Measurement of regional brain volumes in the medial temporal lobes to assess change in regional brain volumes. Reported outcome measure is volume of the right anterior (i.e., head) dentate gyrus, a hippocampal subfield known to show plasticity in response to exercise in animal models. The hippocampus is part of the medial temporal lobes.', 'unitOfMeasure': 'volume in cubic mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training)'}, {'type': 'PRIMARY', 'title': 'Cognitive Test Performance: Spatial Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity\n\nCardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center'}, {'id': 'OG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.\n\nStrength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center'}], 'timeFrame': '4 months', 'description': 'Participants will perform a spatial memory test during functional MRI. Measurements include baseline-to-follow-up change test performance.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to technical errors with the virtual reality (VR) navigation software platform.'}, {'type': 'PRIMARY', 'title': 'Cognitive Test Performance: Virtual Navigation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity\n\nCardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center'}, {'id': 'OG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.\n\nStrength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center'}], 'timeFrame': '4 months', 'description': 'Participants will perform a virtual navigation test during functional MRI. Measurements include baseline-to-follow-up change in test performance.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed due to technical errors with the virtual reality (VR) navigation software platform.'}, {'type': 'PRIMARY', 'title': 'Functional MRI - Post-intervention Right Subiculum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity\n\nCardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center'}, {'id': 'OG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.\n\nStrength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00078057', 'spread': '0.242816203', 'groupId': 'OG000'}, {'value': '-0.17106976', 'spread': '0.231649625', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'The fMRI is measuring blood oxygenation levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. This measurement was obtained while participants were performing a virtual navigation task in the MRI scanner.\n\nData reported for fMRI is in beta-weight for navigation greater control contrast of BOLD images. The beta-weight is a standardized regression coefficient. Higher beta-weights mean greater activation and lower beta-weights mean less activation in specific brain regions being monitored. Negative beta-weights mean lower activation for the navigation condition than for the control condition, positive beta-weights mean greater activation for the navigation condition than for the control condition.', 'unitOfMeasure': 'BOLD Signal (beta weight)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants were excluded due to excess head motion during fMRI (2 RT, 1 ET), 1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training, RT = resistance training)'}, {'type': 'PRIMARY', 'title': 'Structural MRI - Post-intervention Right Dentate Gyrus Head', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity\n\nCardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center'}, {'id': 'OG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.\n\nStrength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center'}], 'classes': [{'categories': [{'measurements': [{'value': '143.0254936', 'spread': '16.36761426', 'groupId': 'OG000'}, {'value': '134.9353733', 'spread': '23.23778171', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Measurement of regional brain volumes in the medial temporal lobes to assess change in regional brain volumes. Reported outcome measure is volume of the right anterior (i.e., head) dentate gyrus, a hippocampal subfield known to show plasticity in response to exercise in animal models. The hippocampus is part of the medial temporal lobes.', 'unitOfMeasure': 'volume in cubic mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training)'}, {'type': 'SECONDARY', 'title': 'Aerobic Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity Cardiovascular endurance: Physical exercise at theBoston University Fitness and Recreation Center'}, {'id': 'OG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training. Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center'}], 'classes': [{'categories': [{'measurements': [{'value': '18.32', 'groupId': 'OG000', 'lowerLimit': '11.63', 'upperLimit': '20.56'}, {'value': '2.62', 'groupId': 'OG001', 'lowerLimit': '1.22', 'upperLimit': '16.12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Participants will perform a treadmill test to estimate baseline-to-follow-up change in aerobic capacity. Aerobic capacity is the maximum amount of oxygen (O2;(expressed in volume: VO2) a person can utilize during strenuous exercise. This maximum volume of oxygen is known as VO2max or aerobic capacity. For this study, we measured heart rate during the treadmill test and estimated VO2max from heart rate, thus we estimated VO2max rather than measured oxygen and carbondioxyde in the breath while exercising. VO2max is expressed in milliliters per kilogram of body weight per minute (ml/kg/min). We calculated percentage change from baseline to post-intervention.', 'unitOfMeasure': 'Percentage change from baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity\n\nCardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center'}, {'id': 'OG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.\n\nStrength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-8.75', 'upperLimit': '13.92'}, {'value': '17.24', 'groupId': 'OG001', 'lowerLimit': '12.55', 'upperLimit': '27.86'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Participants will perform several muscle strength tests to estimate baseline-to-follow-up change in muscle strength. Percentage change in chess press weight lifted is reported in results.', 'unitOfMeasure': 'Percentage change from baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the intervention were included in the analysis (12 cardiovascular endurance group, 7 strength, balance, and flexibility group).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity\n\nCardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center'}, {'id': 'FG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.\n\nStrength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'Participants were first pre-screened over the telephone. At their initial visit, they gave written informed consent for all study procedures (screening, MRI, etc.). Thus, we consider every participant as enrolled who provided consent, and the number of participants started is not the same as the number of participants who were assigned to each Arm. 8 enrolled participants did not start the exercise intervention, 21 were not eligible after screening, leaving 29 who started the intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cardiovascular Endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity\n\nCardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center'}, {'id': 'BG001', 'title': 'Strength, Balance, and Flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.\n\nStrength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center'}, {'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': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.94', 'spread': '5.40', 'groupId': 'BG000'}, {'value': '68.75', 'spread': '5.77', 'groupId': 'BG001'}, {'value': '68.86', 'spread': '5.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', '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': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-17', 'size': 540690, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-14T00:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Suspended due to Covid-19 policies, then terminated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2016-05-11', 'resultsFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2016-05-15', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-08', 'studyFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional MRI - Right Subiculum', 'timeFrame': '0 months-baseline (pre-intervention)', 'description': 'The fMRI is measuring blood oxygenation levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. This measurement was obtained while participants were performing a virtual navigation task in the MRI scanner.\n\nData reported for fMRI is in beta-weight for navigation greater control contrast of BOLD images. The beta-weight is a standardized regression coefficient. Higher beta-weights mean greater activation and lower beta-weights mean less activation in specific brain regions being monitored. Negative beta-weights mean lower activation for the navigation condition than for the control condition, positive beta-weights mean greater activation for the navigation condition than for the control condition.'}, {'measure': 'Structural MRI - Right Dentate Gyrus Head', 'timeFrame': '0 months-baseline (pre-intervention)', 'description': 'Measurement of regional brain volumes in the medial temporal lobes to assess change in regional brain volumes. Reported outcome measure is volume of the right anterior (i.e., head) dentate gyrus, a hippocampal subfield known to show plasticity in response to exercise in animal models. The hippocampus is part of the medial temporal lobes.'}, {'measure': 'Cognitive Test Performance: Spatial Memory', 'timeFrame': '4 months', 'description': 'Participants will perform a spatial memory test during functional MRI. Measurements include baseline-to-follow-up change test performance.'}, {'measure': 'Cognitive Test Performance: Virtual Navigation', 'timeFrame': '4 months', 'description': 'Participants will perform a virtual navigation test during functional MRI. Measurements include baseline-to-follow-up change in test performance.'}, {'measure': 'Functional MRI - Post-intervention Right Subiculum', 'timeFrame': '4 months', 'description': 'The fMRI is measuring blood oxygenation levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. This measurement was obtained while participants were performing a virtual navigation task in the MRI scanner.\n\nData reported for fMRI is in beta-weight for navigation greater control contrast of BOLD images. The beta-weight is a standardized regression coefficient. Higher beta-weights mean greater activation and lower beta-weights mean less activation in specific brain regions being monitored. Negative beta-weights mean lower activation for the navigation condition than for the control condition, positive beta-weights mean greater activation for the navigation condition than for the control condition.'}, {'measure': 'Structural MRI - Post-intervention Right Dentate Gyrus Head', 'timeFrame': '4 months', 'description': 'Measurement of regional brain volumes in the medial temporal lobes to assess change in regional brain volumes. Reported outcome measure is volume of the right anterior (i.e., head) dentate gyrus, a hippocampal subfield known to show plasticity in response to exercise in animal models. The hippocampus is part of the medial temporal lobes.'}], 'secondaryOutcomes': [{'measure': 'Aerobic Capacity', 'timeFrame': '4 months', 'description': 'Participants will perform a treadmill test to estimate baseline-to-follow-up change in aerobic capacity. Aerobic capacity is the maximum amount of oxygen (O2;(expressed in volume: VO2) a person can utilize during strenuous exercise. This maximum volume of oxygen is known as VO2max or aerobic capacity. For this study, we measured heart rate during the treadmill test and estimated VO2max from heart rate, thus we estimated VO2max rather than measured oxygen and carbondioxyde in the breath while exercising. VO2max is expressed in milliliters per kilogram of body weight per minute (ml/kg/min). We calculated percentage change from baseline to post-intervention.'}, {'measure': 'Muscle Strength', 'timeFrame': '4 months', 'description': 'Participants will perform several muscle strength tests to estimate baseline-to-follow-up change in muscle strength. Percentage change in chess press weight lifted is reported in results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brain', 'brain mapping', 'cognition', 'exercise', 'physical activity', 'hippocampus', 'entorhinal cortex', 'spatial navigation', 'learning', 'memory', 'magnetic resonance imaging', 'functional neuroimaging', 'physical endurance', 'physical fitness', 'resistance training', 'walking', 'muscle stretching exercises', 'exercise test', 'neuropsychological tests', 'executive function', 'attention', 'body composition'], 'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '33325614', 'type': 'DERIVED', 'citation': 'Kern KL, Storer TW, Schon K. Cardiorespiratory fitness, hippocampal subfield volumes, and mnemonic discrimination task performance in aging. Hum Brain Mapp. 2021 Mar;42(4):871-892. doi: 10.1002/hbm.25259. Epub 2020 Dec 16.'}], 'seeAlsoLinks': [{'url': 'http://sites.bu.edu/brainplasticity/contact-us/', 'label': 'Brain Plasticity and Neuroimaging Laboratory at Boston University'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this study is to examine how regular exercise affects brain function, spatial memory, and virtual navigation. Participation in this research study will take approximately 4 months.', 'detailedDescription': 'The investigators are examining the effects of exercise and cardiovascular fitness on cognitive processes. Specifically, the investigators are examining if exercise improves brain function in a brain area known as the entorhinal cortex. Together with the hippocampus this brain area is important for memory formation and spatial navigation. Participation in this research study will take approximately 4 months. During this time, participants will make three initial study visits. The first visit is for informed consent and screening, the second visit is for baseline fitness testing, and the third visit is for cognitive testing and a functional MRI exam. Functional MRI is a brain imaging technique that uses a magnetic field to "take pictures" of the brain while a person performs a cognitive task. It will take up to approximately three weeks to complete these initial three study visits. Following the three initial study visits, the exercise-training program will begin. Participants will be randomized to one of two training programs: a cardiovascular endurance-training program (aerobic exercise) and a strength, balance, and flexibility training program (non-aerobic exercise). The exercise training program will last 12 weeks. There will be three one-hour exercise sessions per week. After completion of the exercise-training program, participants will attend two follow-up study visits. The first follow-up visit is for fitness testing. The second follow-up visit is for cognitive testing and an MRI exam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 60-80 years\n* Physical inactivity/sedentary status (The American College of Sports Medicine defines a sedentary lifestyle as a lifestyle in which a person is not participating in at least 30 minutes of moderate intensity physical activity on at least three days per week for at least three months.)\n* Generally healthy\n* Living in the greater Boston area\n* Fluent in English (must have attended elementary school and higher in English)\n* Non-smoking\n\nExclusion Criteria:\n\n* Poor vision that cannot be corrected with glasses or contact lenses\n* Presence of an acute infection\n* Diagnosis of kidney failure\n* Diagnosis of liver disease\n* Diagnosis of thyrotoxicosis/hyperthyroidism\n* Diagnosis of cancer\n* Diagnosis of severe anemia\n* Past or present conditions that affect cognitive functioning:\n\n * learning disability\n * neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)\n * psychiatric disorders or conditions within last 5 years (depression, anxiety disorder, etc.)\n * Severe stress\n* Evidence of cognitive impairment (e.g. dementia)\n* Claustrophobia (fear of small, enclosed spaces)\n* Obesity\n* Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and physical exercise:\n\n * heart conditions (e.g. heart attack, arrhythmias, etc.)\n * circulatory conditions (e.g. uncontrolled hypertension, leg claudication, high cholesterol, etc.)\n * respiratory conditions (e.g., asthma or lung conditions, such as chronic obstructive pulmonary disease, acute bronchitis, acute common cold, lung cancer, pneumonia, etc.)\n * current musculoskeletal impairments (e.g. fractures, hemiplegia, chronic joint pain, arthritis, osteoporosis, not able to walk comfortably without assistance, etc.)\n * diagnosis of electrolyte disorder or abnormality\n * presence of diabetes mellitus\n* Prescription medication or other drugs that treat heart, lung, or circulatory conditions (e.g. beta blockers, bronchodilators, etc.)\n* Prescription medication or other drugs that affect chemicals in the brain (e.g. antidepressants, anxiolytics, etc.)\n* Drug abuse or alcohol misuse\n* Metal in or on the body that cannot be removed (e.g. pacemaker, defibrillator, metal implant that is ferrous)\n* Some known abnormal MRI findings (case by case basis)\n* Regularly exercising\n* Unavailable for the approx. 4-month duration of the study'}, 'identificationModule': {'nctId': 'NCT02775760', 'acronym': 'ECE', 'briefTitle': 'The Entorhinal Cortex and Aerobic Exercise in Aging', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'The Entorhinal Cortex and Aerobic Exercise in Aging', 'orgStudyIdInfo': {'id': 'H-34579'}, 'secondaryIdInfos': [{'id': 'R21AG049968', 'link': 'https://reporter.nih.gov/quickSearch/R21AG049968', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiovascular endurance', 'description': 'Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity', 'interventionNames': ['Behavioral: Cardiovascular endurance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Strength, balance, and flexibility', 'description': 'Participants will undergo Strength, balance, and flexibility training.', 'interventionNames': ['Behavioral: Strength, balance, and flexibility']}], 'interventions': [{'name': 'Cardiovascular endurance', 'type': 'BEHAVIORAL', 'description': 'Physical exercise at the Boston University Fitness and Recreation Center', 'armGroupLabels': ['Cardiovascular endurance']}, {'name': 'Strength, balance, and flexibility', 'type': 'BEHAVIORAL', 'description': 'Physical exercise at the Boston University Fitness and Recreation Center', 'armGroupLabels': ['Strength, balance, and flexibility']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University School of Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Karin Schon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Georgia Institute of Technology', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}