Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-08 @ 3:13 AM
Study NCT ID:
NCT02994134
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise, Cognitive Function and Neuroplasticity in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2016-12-12', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cortical synaptic plasticity using transcranial magnetic stimulation (TMS) from baseline to post-exercise.', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Plasticity with TMS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedentary Lifestyle']}, 'descriptionModule': {'briefSummary': 'The overall goal of the proposed study is to compare the effects of 4 weeks of moderate or high intensity aerobic exercise on neuroplasticity, cognitive performance and gait and postural control in sedentary healthy adults.', 'detailedDescription': 'The primary aim of the study is to compare the effects of a moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate) with a high intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart rate) on measures that probe cortical synaptic plasticity using transcranial magnetic stimulation (TMS) in sedentary healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult males and females aged 18-70 years old\n* Primary language is English\n* Sedentary (defined as not engaging in purposeful physical activity more than 2 times over the last two months)\n* Exercise clearance\n\nExclusion Criteria:\n\n* Presence of cognitive, neurologic or orthopedic conditions that could affect performance of the testing and training procedures\n* History of migraines.\n* History of fainting spells of unknown or undetermined etiology that might constitute seizures\n* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or family history of treatment resistant epilepsy\n* Any current history of a psychiatric illness\n* Any unstable medical condition\n* No medication is an absolute exclusion from TMS. Medications will be reviewed by the Principal Investigator and a decision about inclusion will be made based on the following:\n\n * The subject's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS active drugs.\n * The published TMS guidelines review medications to be considered with TMS (Rossi, Hallett, Rossini, Pascual-Leone, \\& Safety of TMS Consensus Group, 2009).\n* Any metal in the brain, skull or elsewhere unless approved by the responsible MD\n* Any medical devices (i.e. Cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator)\n* Intracranial lesion\n* Substance abuse or dependence within the past six months Subjects who, in the Investigator's opinion, might not be suitable for the study"}, 'identificationModule': {'nctId': 'NCT02994134', 'briefTitle': 'Exercise, Cognitive Function and Neuroplasticity in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Exercise, Cognitive Function and Neuroplasticity in Healthy Adults', 'orgStudyIdInfo': {'id': '20161059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate intensity exercise.', 'description': 'Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.', 'interventionNames': ['Behavioral: Moderate intensity exercise.']}, {'type': 'EXPERIMENTAL', 'label': 'High intensity exercise', 'description': 'High intensity aerobic exercise intervention (delivered at 65%-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.', 'interventionNames': ['Behavioral: High intensity exercise.']}], 'interventions': [{'name': 'Moderate intensity exercise.', 'type': 'BEHAVIORAL', 'description': 'Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.', 'armGroupLabels': ['Moderate intensity exercise.']}, {'name': 'High intensity exercise.', 'type': 'BEHAVIORAL', 'description': 'High intensity aerobic exercise intervention (delivered at 65-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.', 'armGroupLabels': ['High intensity exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Joyce R Gomes Osman, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Joyce Rios Gomes Osman', 'investigatorAffiliation': 'University of Miami'}}}}