Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT02237560
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2014-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Aerobic & Cognitive Exercise Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2014-09-04', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in BDNF at 6-months', 'timeFrame': 'Baseline and 6-months', 'description': 'BDNF levels (collected from saliva samples) at 6-months will be compared with baseline levels.'}, {'measure': 'Change from baseline in MRI at 6-months', 'timeFrame': 'Baseline and 6-months', 'description': 'MRI scans collected at baseline and 6-months will be analyzed for volumetric changes.'}, {'measure': 'Cognitive characteristics of sample pre- and post- intervention', 'timeFrame': 'Baseline and 6-months', 'description': 'The MoCA, ADAS-Cog word recall, complex figures, and controlled oral word association test will be used to characterize the sample based on cognitive function at pre- and post-intervention.'}, {'measure': 'Assessment of exercise behavior during intervention', 'timeFrame': 'After each exercise session', 'description': 'Participants are asked to exercise 3-5x/week. After each exercise session subjects will record their exercise data (e.g., time, distance, power, heart rate, calories, points).'}], 'primaryOutcomes': [{'measure': 'Change from baseline in executive function at 6-months', 'timeFrame': 'Baseline and 6-months', 'description': 'Change in executive function from baseline at 6-months will be assessed by using a composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.'}], 'secondaryOutcomes': [{'measure': 'Change in weight', 'timeFrame': 'Baseline, 3-months, 6-months, 1-year', 'description': 'Weight and other physiological factors will be assessed at baseline, 3-months, 6-months, and 1-year follow-up'}, {'measure': 'Change in mood', 'timeFrame': 'Baseline, 3-months, 6-months, 1-year follow-up', 'description': 'Behavioral outcomes (e.g., mood) will be assessed using the Brunel Mood Scale and exercise induced feeling inventory.'}, {'measure': 'Change from baseline in executive function at 3-months', 'timeFrame': 'Baseline and 3-months', 'description': 'Change from baseline in executive function will be assessed using composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.'}, {'measure': 'Change from baseline in executive function at 1-year follow-up', 'timeFrame': 'Baseline and 1-year', 'description': 'Change from baseline in executive function will be assessed using composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MCI', 'Exergaming', 'Cognition', 'Exercise', 'Older Adults'], 'conditions': ['Mild Cognitive Impairment', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '29780318', 'type': 'DERIVED', 'citation': 'Anderson-Hanley C, Barcelos NM, Zimmerman EA, Gillen RW, Dunnam M, Cohen BD, Yerokhin V, Miller KE, Hayes DJ, Arciero PJ, Maloney M, Kramer AF. The Aerobic and Cognitive Exercise Study (ACES) for Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment (MCI): Neuropsychological, Neurobiological and Neuroimaging Outcomes of a Randomized Clinical Trial. Front Aging Neurosci. 2018 May 4;10:76. doi: 10.3389/fnagi.2018.00076. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to clarify the benefits to brain health and thinking processes that result from different forms of exercise. This study will examine the effectiveness of cybercycling (virtual reality enhanced stationary cycling) for persons at risk for and with MCI, and compare this with the individual cognitive, behavioral, and physiological effects of physical and mental exercise alone. The Investigators hypothesis that cognitive benefit will be greatest for combined aerobic and cognitive exercise compared to physical and mental exercise alone.', 'detailedDescription': 'This is a multi-site, randomized controlled trial. Participants will be randomized into one of three conditions for six months: cybercycle-tour, cybercycle-game, or videogame alone. Comprehensive evaluations will include: neuropsychological (e.g., executive function and memory), behavioral (e.g., compliance and effort/watts), physiological (e.g., cardiorespiratory fitness), biomarker (e.g., BDNF), and an expanded neuroimaging pilot. After the six-month intervention period, participants choose whether or not to continue exercising, using any of the three conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 50+\n* able to pedal recumbent stationary bicycle\n* available for regular exercise participation 3-5x/week for at least 6 months\n* physician permission to exercise\n\nExclusion Criteria:\n\n* unstable heart condition or other significant cardiovascular history (e.g,. stroke)\n* meets criteria for Alzheimer's or other dementia\n* significant history of other neurological disease (e.g., seizures, Parkinson's, etc.)\n* physician denial to exercise"}, 'identificationModule': {'nctId': 'NCT02237560', 'acronym': 'ACES', 'briefTitle': 'The Aerobic & Cognitive Exercise Study', 'organization': {'class': 'OTHER', 'fullName': 'Union College, New York'}, 'officialTitle': 'The Cognitive Benefits of Interactive Mental and Physical Exercise for Older Adults at Risk for or With Mild Cognitive Impairment (MCI)', 'orgStudyIdInfo': {'id': 'HS13083'}, 'secondaryIdInfos': [{'id': 'R15AG042109-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R15AG042109-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cybercycle-Game', 'description': 'Combined aerobic \\& cognitive exercise for 6 months, 3-5x/week.', 'interventionNames': ['Behavioral: Cybercycle-Game']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cybercyle-Tour', 'description': 'Aerobic exercise only for 6 months, 3-5x/week.', 'interventionNames': ['Behavioral: Cybercyle-Tour']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Game Only', 'description': 'Cognitive exercise only 6 months, 3-5x/week.', 'interventionNames': ['Behavioral: Game Only']}], 'interventions': [{'name': 'Cybercycle-Game', 'type': 'BEHAVIORAL', 'otherNames': ['Expresso', 'Dragon Chase'], 'description': 'Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.', 'armGroupLabels': ['Cybercycle-Game']}, {'name': 'Cybercyle-Tour', 'type': 'BEHAVIORAL', 'otherNames': ['Expresso'], 'description': 'Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.', 'armGroupLabels': ['Cybercyle-Tour']}, {'name': 'Game Only', 'type': 'BEHAVIORAL', 'otherNames': ['Dragon Chase'], 'description': 'While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).', 'armGroupLabels': ['Game Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Sidney Albert Albany Jewish Community Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Stratton VA Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '12061', 'city': 'East Greenbush', 'state': 'New York', 'country': 'United States', 'facility': 'Hawthorne Ridge', 'geoPoint': {'lat': 42.59091, 'lon': -73.70179}}, {'zip': '12084', 'city': 'Guilderland', 'state': 'New York', 'country': 'United States', 'facility': 'Guilderland YMCA', 'geoPoint': {'lat': 42.70452, 'lon': -73.91151}}, {'zip': '12309', 'city': 'Niskayuna', 'state': 'New York', 'country': 'United States', 'facility': 'Glen Eddy', 'geoPoint': {'lat': 42.7798, 'lon': -73.84568}}, {'zip': '12148', 'city': 'Rexford', 'state': 'New York', 'country': 'United States', 'facility': 'Coburg Village', 'geoPoint': {'lat': 42.85313, 'lon': -73.8879}}, {'zip': '12866', 'city': 'Saratoga Springs', 'state': 'New York', 'country': 'United States', 'facility': 'Prestwick Chase', 'geoPoint': {'lat': 43.08313, 'lon': -73.78457}}, {'zip': '12304', 'city': 'Schenectady', 'state': 'New York', 'country': 'United States', 'facility': 'Kingsway Parkland GardenApartments', 'geoPoint': {'lat': 42.81424, 'lon': -73.93957}}, {'zip': '12308', 'city': 'Schenectady', 'state': 'New York', 'country': 'United States', 'facility': 'Schaffer Heights', 'geoPoint': {'lat': 42.81424, 'lon': -73.93957}}, {'zip': '12308', 'city': 'Schenectady', 'state': 'New York', 'country': 'United States', 'facility': 'Sunnyview Rehabilitation Center', 'geoPoint': {'lat': 42.81424, 'lon': -73.93957}}, {'zip': '12159', 'city': 'Slingerlands', 'state': 'New York', 'country': 'United States', 'facility': 'Beverwyck', 'geoPoint': {'lat': 42.62925, 'lon': -73.86457}}], 'overallOfficials': [{'name': 'Cay Anderson-Hanley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union College, New York', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Cay Anderson-Hanley, PhD', 'investigatorAffiliation': 'Union College, New York'}}}}