Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT00979069
Status:
COMPLETED
Last Update Posted:
2014-11-26
First Post:
2009-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aerobic Exercise to Improve Executive Language Function In Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joe.nocera2@va.gov', 'phone': '404 321 6111', 'title': 'Dr. Joe Nocera', 'phoneExt': '6354', 'organization': 'Atlanta VAMC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During study collection', 'eventGroups': [{'id': 'EG000', 'title': 'Aerobic Group', 'description': '12 weeks of aerobic exercise 3 times a week\n\nAerobic group: 12 weeks of aerobic exercise 3 times a week', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'No contact control', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Executive Language Functions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerobic Group', 'description': '12 weeks of aerobic exercise 3 times a week\n\nAerobic group: 12 weeks of aerobic exercise 3 times a week'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No contact control'}], 'classes': [{'title': 'Letter Verbal Fluency- Pre', 'categories': [{'measurements': [{'value': '31.6', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Letter Verbal Fluency- Post', 'categories': [{'measurements': [{'value': '33.7', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '31.8', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Category Verbal Fluency- Pre', 'categories': [{'measurements': [{'value': '39', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '40.2', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Category Verbal Fluency- Post', 'categories': [{'measurements': [{'value': '45.1', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '41', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Switching Verbal Fluency- Pre', 'categories': [{'measurements': [{'value': '10.6', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Switching Verbal Fluency- Post', 'categories': [{'measurements': [{'value': '13.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'number of correct words at pre and post separated by 12 weeks', 'description': 'The Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89 (Delis, et al., 2001; Delis, Kramer, Kaplan, \\& Hodnack, 2004). The Verbal Fluency Test has three conditions, Letter Verbal Fluency, Category Verbal Fluency, and Switching Verbal Fluency. Each was randomized at pre- and post-12 week timeline and equated for difficulty. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds,the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds, and the Switching Verbal Fluency assesses the number of words while alternating between different categories participants can generate within 60 seconds. For each condition (letter, category, and switching) a total score representing the total number of correct', 'unitOfMeasure': 'Mean outpoint by group at pre and post', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aerobic Group', 'description': '12 weeks of aerobic exercise 3 times a week\n\nAerobic group: 12 weeks of aerobic exercise 3 times a week'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'No contact control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aerobic Group', 'description': '12 weeks of aerobic exercise 3 times a week\n\nAerobic group: 12 weeks of aerobic exercise 3 times a week'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'No contact control'}, {'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': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', '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': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2009-09-15', 'resultsFirstSubmitDate': '2014-09-18', 'studyFirstSubmitQcDate': '2009-09-16', 'lastUpdatePostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-29', 'studyFirstPostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Executive Language Functions', 'timeFrame': 'number of correct words at pre and post separated by 12 weeks', 'description': 'The Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89 (Delis, et al., 2001; Delis, Kramer, Kaplan, \\& Hodnack, 2004). The Verbal Fluency Test has three conditions, Letter Verbal Fluency, Category Verbal Fluency, and Switching Verbal Fluency. Each was randomized at pre- and post-12 week timeline and equated for difficulty. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds,the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds, and the Switching Verbal Fluency assesses the number of words while alternating between different categories participants can generate within 60 seconds. For each condition (letter, category, and switching) a total score representing the total number of correct'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '24425525', 'type': 'RESULT', 'citation': 'Nocera JR, McGregor KM, Hass CJ, Crosson B. Spin exercise improves semantic fluency in previously sedentary older adults. J Aging Phys Act. 2015 Jan;23(1):90-4. doi: 10.1123/japa.2013-0107. Epub 2014 Jan 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if exercise can improve brain function in older adults', 'detailedDescription': 'Recently, considerable attention has been devoted to examining the beneficial relationship between cognition and aerobic exercise in older adults. Specifically, the effects are thought to involve higher order cognitive processes, such as working memory, switching between tasks, and inhibiting irrelevant information, all of which are thought to be sub- served, in part, by the frontal lobes (Colcombe et al., 2006). Importantly, these areas also are most susceptible to age-related decline (Raz, 2000) and are essential resources for language production (Kemper \\& Sumner, 2001; Murray \\& Lenz, 2001). However, despite promising cognitive improvement, changes in frontally-mediated executive language functions have been widely ignored. This is unfortunate considering impaired word retrieval compromises communicative effectiveness, leading to frustration, depression, and withdrawal. Perhaps more importantly, communication ineffectiveness, particularly in the elderly, leads to difficulties interacting with health care professionals leading to further health care burdens. Since cognition, and specifically word retrieval difficulties, usually remain untreated, it is important to find treatment strategies for minimizing these deficits. Therefore, the short-term goal and the purpose of this proposal is to examine the potential of aerobic exercise to improve executive language function in older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Consent of participants' primary health care physicians to participate in the aerobic exercise.\n* Patients must not have participated in any consistent exercise program or experimental study for at least 3 months prior to enrollment.\n* They must be capable of providing informed consent and complying with the trial procedures.\n\nExclusion Criteria:\n\n* Demented as defined by the Modified Mini Mental Status Exam.\n* Unalterable travel schedules.\n* Site accessibility constraints."}, 'identificationModule': {'nctId': 'NCT00979069', 'briefTitle': 'Aerobic Exercise to Improve Executive Language Function In Older Adults', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Aerobic Exercise to Improve Executive Language Function in Older Adults', 'orgStudyIdInfo': {'id': 'E6860-M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic Group', 'description': '12 weeks of aerobic exercise 3 times a week', 'interventionNames': ['Behavioral: Aerobic group']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No contact control'}], 'interventions': [{'name': 'Aerobic group', 'type': 'BEHAVIORAL', 'description': '12 weeks of aerobic exercise 3 times a week', 'armGroupLabels': ['Aerobic Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida/South Georgia Veterans Health System, Gainesville, FL', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical and Rehab Center, Decatur, GA', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}], 'overallOfficials': [{'name': 'Joe R Nocera, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlanta VA Medical and Rehab Center, Decatur, GA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}