Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-27 @ 7:06 PM
Study NCT ID:
NCT04120792
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2019-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Aerobic and Cognitive Training System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'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': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-07', 'studyFirstSubmitDate': '2019-10-04', 'studyFirstSubmitQcDate': '2019-10-07', 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in Wechsler Adult Intelligence Scale-IV Digit Span total score', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'A measure of working memory'}, {'measure': 'Change from baseline in Wechsler Adult Intelligence Scale-IV Coding total score', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'A measure of information processing'}, {'measure': 'Change from baseline in Wechsler Adult Intelligence Scale-IV Letter-Number Sequencing total score', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'A measure of working memory'}, {'measure': 'Change from baseline in Wechsler Memory Scale-IV Paired-Associates I total score', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'A measure of verbal learning'}, {'measure': 'Change from baseline in Auditory Verbal Learning Test total learning score', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'A test of verbal list learning'}, {'measure': 'Change from baseline in Trail Making Test, part A total time', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Tests of visuomotor tracking and complex attention'}, {'measure': 'Change from baseline in Trail Making Test, part B total time', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Tests of visuomotor tracking and complex attention'}, {'measure': 'Change from baseline in Stroop Color and Word Test Color/Word Interference total score', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'A test to assess inhibition when reading color words'}, {'measure': 'Change from baseline in Deary-Liewald Reaction Time Task Simple median response time', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Tests to measure speed of information processing'}, {'measure': 'Change from baseline in Deary-Liewald Reaction Time Task Choice median correct response time', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Tests to measure speed of information processing'}], 'primaryOutcomes': [{'measure': 'Change from baseline in cognitive function during dual-task test at 12 weeks', 'timeFrame': 'Baseline and 12-weeks', 'description': 'Performance on serial subtraction during dual-task walking.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in stride length during dual-task test', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The difference between stride length in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks'}, {'measure': 'Change from baseline in stride duration during dual-task test', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The difference between stride duration in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks'}, {'measure': 'Change from baseline in stride velocity during dual-task test', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The difference between stride velocity in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks'}, {'measure': 'Change from baseline in stride length variability during dual-task test', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The difference between stride length variability (measured by coefficient of variation) in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks'}, {'measure': 'Change from baseline in stride duration variability during dual-task test', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The difference between stride duration variability (measured by coefficient of variation) in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks'}, {'measure': 'Change from baseline in stride velocity variability during dual-task test', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The difference between stride velocity variability (measured by coefficient of variation) in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks'}, {'measure': 'Change from baseline in cognitive function during dual-task test at 6 weeks', 'timeFrame': 'Baseline and 6-weeks', 'description': 'Performance on serial subtraction during dual-task walking.'}]}, 'conditionsModule': {'conditions': ['Healthy Aging']}, 'referencesModule': {'references': [{'pmid': '32122325', 'type': 'DERIVED', 'citation': 'Raichlen DA, Bharadwaj PK, Nguyen LA, Franchetti MK, Zigman EK, Solorio AR, Alexander GE. Effects of simultaneous cognitive and aerobic exercise training on dual-task walking performance in healthy older adults: results from a pilot randomized controlled trial. BMC Geriatr. 2020 Mar 2;20(1):83. doi: 10.1186/s12877-020-1484-5.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effects of simultaneous exercise and cognitive training on cognitive function in healthy older adults. Specifically, this study will compare the use of a tablet-based cognitive training system while exercising with exercise alone, cognitive training alone, and a neutral control condition on cognition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGenerally healthy, age 60-74, and a written statement from their primary care physician indicating that they are able to participate in the 12-week exercise program.\n\nExclusion Criteria:\n\nSubjects will be excluded from participating in the study if they express significant concerns about their memory or declines in other cognitive abilities, if they are not English speaking, or if they have histories of significant major neurological, psychiatric, or medical disorder or injury that would affect cognitive function.'}, 'identificationModule': {'nctId': 'NCT04120792', 'briefTitle': 'The Aerobic and Cognitive Training System', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'The Aerobic and Cognitive Training System to Improve Cognition', 'orgStudyIdInfo': {'id': 'UA15-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simultaneous exercise and cognitive training', 'description': 'Participants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week.', 'interventionNames': ['Behavioral: Simultaneous exercise and cognitive training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise training', 'description': 'Participants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week.', 'interventionNames': ['Behavioral: Exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive training', 'description': 'Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week.', 'interventionNames': ['Behavioral: Cognitive Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neutral Video', 'description': 'Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week.', 'interventionNames': ['Behavioral: Neutral video']}], 'interventions': [{'name': 'Simultaneous exercise and cognitive training', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week.', 'armGroupLabels': ['Simultaneous exercise and cognitive training']}, {'name': 'Exercise training', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week.', 'armGroupLabels': ['Exercise training']}, {'name': 'Cognitive Training', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week.', 'armGroupLabels': ['Cognitive training']}, {'name': 'Neutral video', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week.', 'armGroupLabels': ['Neutral Video']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gene Alexander', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}, {'name': 'David Raichlen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}