Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT02864069
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ajak@ucsd.edu', 'phone': '8586423742', 'title': 'Dr. Amy Jak', 'organization': 'UCSD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Walking Intervention', 'description': 'Walking Intervention: The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cognitive Training Intervention', 'description': 'Cognitive Training Intervention: In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Combined Intervention', 'description': 'Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rivermead Behavioral Memory Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Walking Intervention', 'description': 'Walking Intervention: The walking intervention will begin following baseline assessments and will be continued for 12 weeks. 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If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.'}, {'id': 'OG002', 'title': 'Combined Intervention', 'description': 'Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.08', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '2.95', 'groupId': 'OG001'}, {'value': '12.31', 'spread': '1.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Rivermead Behavioral Memory Test (RBMT) is an ecologically valid assessment of cognitive functioning that tests some skills specifically trained in the CT condition (e.g., name learning, and story learning) but also additional untrained skills such as prospective memory. 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After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.'}, {'id': 'OG001', 'title': 'Cognitive Training Intervention', 'description': 'Cognitive Training Intervention: In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.'}, {'id': 'OG002', 'title': 'Combined Intervention', 'description': 'Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '.64', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '.17', 'groupId': 'OG001'}, {'value': '1.24', 'spread': '.30', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Everyday Cognition Scale (ECog) assesses (via informant report) everyday cognitive functioning in memory, language, visuospatial, and executive functioning domains. 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After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.'}, {'id': 'OG001', 'title': 'Cognitive Training Intervention', 'description': 'Cognitive Training Intervention: In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.'}, {'id': 'OG002', 'title': 'Combined Intervention', 'description': 'Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.08', 'spread': '20.74', 'groupId': 'OG000'}, {'value': '72.20', 'spread': '7.46', 'groupId': 'OG001'}, {'value': '68.15', 'spread': '16.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Self report assessment of quality of life specific to older adults. Assessment covers life overall, health, social relationships and participation, independence, control over life and freedom, home and neighborhood, psychological and emotional well-being, financial circumstances, leisure/activities, and culture and religion. Total score minimum = 35, max = 175; lower scores indicate better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Walking Intervention', 'description': 'Walking Intervention: The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.'}, {'id': 'FG001', 'title': 'Cognitive Training Intervention', 'description': 'Cognitive Training Intervention: In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.'}, {'id': 'FG002', 'title': 'Combined Intervention', 'description': 'Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Walking Intervention', 'description': 'Walking Intervention: The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.'}, {'id': 'BG001', 'title': 'Cognitive Training Intervention', 'description': 'Cognitive Training Intervention: In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.'}, {'id': 'BG002', 'title': 'Combined Intervention', 'description': 'Combined Intervention: The combined condition will concurrently follow both the walking and the CT programs as described above.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.06', 'spread': '5.79', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '4.06', 'groupId': 'BG001'}, {'value': '69.48', 'spread': '6.32', 'groupId': 'BG002'}, {'value': '69.0', 'spread': '6.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-04', 'size': 105395, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-30T16:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-07', 'studyFirstSubmitDate': '2016-06-27', 'resultsFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-07', 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rivermead Behavioral Memory Test', 'timeFrame': '12 weeks', 'description': 'The Rivermead Behavioral Memory Test (RBMT) is an ecologically valid assessment of cognitive functioning that tests some skills specifically trained in the CT condition (e.g., name learning, and story learning) but also additional untrained skills such as prospective memory. Belongings subtest scaled scores: Minimum score = 1, Maximum score = 19; higher values represent better performance.'}, {'measure': 'Everyday Cognition Scale', 'timeFrame': '12 weeks', 'description': 'The Everyday Cognition Scale (ECog) assesses (via informant report) everyday cognitive functioning in memory, language, visuospatial, and executive functioning domains. Average total score was used: Minimum = 1, Maximum = 4, higher scores indicate greater impairment'}, {'measure': 'Older Peoples Quality of Life Questionnaire', 'timeFrame': '12 weeks', 'description': 'Self report assessment of quality of life specific to older adults. Assessment covers life overall, health, social relationships and participation, independence, control over life and freedom, home and neighborhood, psychological and emotional well-being, financial circumstances, leisure/activities, and culture and religion. Total score minimum = 35, max = 175; lower scores indicate better quality of life.'}]}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk for cognitive decline and dementia, with combinations of non-pharmacological interventions providing greatest promise for impacting cognitive aging. This, paired with limited cognitive benefits from pharmacological interventions in dementia, has shifted focus to non-pharmacological interventions administered earlier in the disease course. This application, therefore, proposes a randomized controlled trial (RCT; 12-week active intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided progressive increases in weekly step counts), computer-based cognitive training program (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults with mild cognitive impairment (MCI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MCI diagnosis (can be self referral, will determine eligibility at baseline)\n\nExclusion Criteria:\n\n* Dementia diagnosis\n* Head trauma\n* Neuro/psychiatric disorders\n* Current substance dependence\n* Sensory/mobility deficits\n* No more than 1 hour of purposeful, aerobic activity/week\n* Currently engaging in any other brain-stimulating computer program (No more than 1 hour a week)'}, 'identificationModule': {'nctId': 'NCT02864069', 'acronym': 'CBI', 'briefTitle': 'Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI', 'orgStudyIdInfo': {'id': 'NPSASA-14-321959'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Walking Intervention', 'interventionNames': ['Behavioral: Walking Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive Training Intervention', 'interventionNames': ['Behavioral: Cognitive Training Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Intervention', 'interventionNames': ['Behavioral: Combined Intervention']}], 'interventions': [{'name': 'Walking Intervention', 'type': 'BEHAVIORAL', 'description': 'The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.', 'armGroupLabels': ['Walking Intervention']}, {'name': 'Cognitive Training Intervention', 'type': 'BEHAVIORAL', 'description': 'In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.', 'armGroupLabels': ['Cognitive Training Intervention']}, {'name': 'Combined Intervention', 'type': 'BEHAVIORAL', 'description': 'The combined condition will concurrently follow both the walking and the CT programs as described above.', 'armGroupLabels': ['Combined Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Amy Jak, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': "Alzheimer's Association", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry', 'investigatorFullName': 'Amy Jak', 'investigatorAffiliation': 'University of California, San Diego'}}}}