Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT02567227
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2015-08-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cognitive Remediation to Improve Mobility in Sedentary Seniors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051346', 'term': 'Mobility Limitation'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072466', 'term': 'Cognitive Remediation'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joe.verghese@einsteinmed.org', 'phone': '718-430-3877', 'title': 'Dr. Joe Verghese', 'organization': 'Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months from intervention', 'description': 'Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits', 'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.", 'otherNumAtRisk': 192, 'deathsNumAtRisk': 192, 'otherNumAffected': 49, 'seriousNumAtRisk': 192, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 34, 'seriousNumAtRisk': 191, 'deathsNumAffected': 2, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 41, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 43, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Walking Speed During Single and Dual-task Conditions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'title': 'Normal pace walking', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Walking while talking', 'categories': [{'measurements': [{'value': '6.02', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '5.43', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.03', 'ciLowerLimit': '-3.60', 'ciUpperLimit': '1.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.30', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (Mild Cognitive Impairment (MCI) or cognitively normal) were used to compare changes in speed during normal pace walking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '-2.59', 'ciUpperLimit': '3.76', 'pValueComment': 'P-values from linear mixed effects models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.61', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in speed during walking while talking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm of gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system).', 'unitOfMeasure': 'centimeters per second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Change in Short Physical Performance Battery (SPPB).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.70', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in SPPB scores pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in mobility measured using the SPPB. The SPPB is comprised of balance, chair rise, and gait speed tests. A score is assigned in each of these three areas (0-4), and summed to obtain an overall summary score (0-12, higher better).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator)'}, {'type': 'SECONDARY', 'title': 'Stride Length.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'title': 'Walking while talking stride length', 'categories': [{'measurements': [{'value': '3.09', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '2.26', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Normal walking stride length', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '-2.13', 'ciUpperLimit': '3.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.50', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length during walking while talking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.04', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models.', 'groupDescription': 'Unadjusted linear mixed effects models were used to compare changes in stride length during normal walking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in stride length (cm) collected during normal walking and walking while talking conditions on an instrumented walkway.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Gait Variability.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'title': 'Normal walking gait variability', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Walking while talking gait variability', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during normal walking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during walking while talking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in gait stride length variability, measured in standard deviation units, collected during normal walking and walking while talking on an instrumented walkway. Gait variability is defined as differences in length from one stride to the next.', 'unitOfMeasure': 'standard deviation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Variability in Gait Domains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'title': 'Normal walking pace', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Normal walking rhythm', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Normal walking variation', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Walking while talking pace', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Walking while talking rhythm', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Walking while talking variation', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.19', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during normal pace walking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.41', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during normal pace walking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.32', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during normal pace walking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.56', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during walking while talking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.45', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during walking while talking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.35', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during walking while talking pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm in gait domains (summary measures reported as standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal walking and walking while talking. Based on previous findings of gait patterns, pace, rhythm and variation factors are defined (using z-scores based on mean and standard deviation at baseline). Higher values are indicative of better performance for pace and rhythm factors and indicative of worse performance for variation factors.', 'unitOfMeasure': 'standard deviation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Substantial Gait Speed Change.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'title': 'Substantial normal walking speed improvement', 'categories': [{'title': 'Improved walking speed ≥1 standard deviation units from baseline', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Did not improve walking speed ≥1 standard deviation units from baseline', 'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': 'Substantial walking while talking speed improvement', 'categories': [{'title': 'Improved walking speed ≥1 standard deviation units from baseline', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'Did not improve walking speed ≥1 standard deviation units from baseline', 'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.925', 'ciLowerLimit': '0.369', 'ciUpperLimit': '2.319', 'groupDescription': 'Logistic model for treatment effect on substantial improvement in normal velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.961', 'ciLowerLimit': '0.516', 'ciUpperLimit': '1.789', 'groupDescription': 'Logistic model for treatment effect on substantial improvement in walking while talking velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 2 Months', 'description': 'Substantial gait speed improvement is defined as change of ≥1 standard deviation units from baseline performance in gait speed measured during normal walking and walking while talking conditions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator) and participants who did not complete the 2 month follow-up assessment (n=34 Experimental; n=24 Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Flanker Task.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.05', 'spread': '9.48', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '10.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.52', 'ciLowerLimit': '-35.45', 'ciUpperLimit': '20.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.17', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in Flanker performance (milliseconds) pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm on the Flanker task, a measure of speed of processing, attention and inhibitory control. Scoring is based on reaction time in milliseconds (ms) and calculated as the difference in reaction time that it takes a person, on average, to respond to an incongruent minus congruent stimulus. Lower values reflect better outcome.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator) and 86 participants (n=43 Experimental; n=43 Active Comparator) with performance inaccuracy \\>75%.'}, {'type': 'SECONDARY', 'title': 'Digit Symbol Substitution Test.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '2.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.66', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes on the Digit Symbol Substitution Test pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm on the Digit Symbol Substitution Test (a subtest of the Wechsler Adult Intelligence Scale - Revised), a measure of attention, transcription and speed of processing. Scoring is based on the total number of correct responses generated during a 90-sec time interval. Scores range from 0-133 with higher scores indicating better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Trail Making Test Form A.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'estimateComment': 'Estimates with standard errors are from unadjusted linear mixed effect models.', 'groupDescription': 'Unadjusted linear mixed effects model was used to compare performance on Trail Making Test form A pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm on Trail Making Test form A, a timed measure of attention. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis.', 'unitOfMeasure': 'log (scores on a scale)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Trail Making Test Form B.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in performance on Trail Making Test form B pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm on Trail Making Test form B, a timed measure of attention, set shifting and processing speed. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis.', 'unitOfMeasure': 'log (scores on a scale)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Controlled Oral Word Association Test.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '2.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.78', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes performance on the Controlled Oral Word Association Test pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm on the Controlled Oral Word Association Test, a verbal fluency test that measures word generation performance under specified timed phonemic and semantic conditions. Performance measured by the total number of correct words as well as the number of errors. Scores range from 25-41 seconds with higher scores indicating better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Repeatable Battery for the Assessment of Neuropsychological Status.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change on the Repeatable Battery for the Assessment of Neuropsychological Status, a relatively brief battery that assesses overall level of cognitive function This battery consists of 10 neurocognitive tests measuring memory (immediate and delayed), attention, language, visuospatial abilities and executive functions. Performance is converted to standardized scores derived from a normative sample.', 'reportingStatus': 'POSTED', 'populationDescription': 'No outcome measure data was collected for this outcome.'}, {'type': 'SECONDARY', 'title': 'Neuroplasticity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'timeFrame': 'Baseline and 2 Months', 'description': 'Changes in prefrontal activation measure using functional near infra-red spectroscopy.', 'reportingStatus': 'POSTED', 'populationDescription': 'No outcome measure data was collected for this outcome.'}, {'type': 'SECONDARY', 'title': 'Durability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'title': 'Normal Walking Gait Speed', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Walking While Talking Gait Speed', 'categories': [{'measurements': [{'value': '3.16', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '1.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '3.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.42', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during normal walking pre and 6 months post intervention.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '4.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.79', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during walking while talking pre and 6 months post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Between group difference in change per arm in gait speed during normal pace and walking while talking conditions measured at six months.', 'unitOfMeasure': 'centimeters per second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Stair Climbing Time.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'estimateComment': 'Estimates with standard errors are from unadjusted linear mixed effect models.', 'groupDescription': 'Unadjusted linear mixed effects model was used to compare changes in stair climbing time pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm in mobility and balance assessed during stair climbing, which provides a valid assessment tool for predicting disability. Scores are measured as time in seconds to climb 3 stairs with longer time indicating worse performance. Scores were log transformed prior to analysis.', 'unitOfMeasure': 'log (seconds)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'SECONDARY', 'title': 'Disability Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'Estimates with standard errors are from unadjusted linear mixed effect models.', 'groupDescription': 'Unadjusted linear mixed effects model was used to compare changes in activities of daily living pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm in mobility assessed by activities of daily living tasks on the Activities of Daily Living-Prevention Instrument. Scores range from 0-45 and higher scores indicate poorer function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Geriatric Depression Scale (GDS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in depressive symptoms measured using the GDS pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rosenberg Self-Esteem Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in self-esteem assessed using a ten-item Likert-type scale (higher scores are better).', 'reportingStatus': 'POSTED', 'populationDescription': 'Only baseline data was collected on this outcome measure, therefore no data was analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Falls Efficacy Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '2.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.90', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in reported fear of falling measured on the Falls Efficacy Scale pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in self-efficacy scores (range 0-100). Higher scores indicate less confidence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '12-Item Short Form Health Survey (SF-12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'OG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'classes': [{'title': 'Physical Component Summary', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component Summary', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '1.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.64', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the physical health score of the SF-12 pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '1.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.73', 'estimateComment': 'Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.', 'groupDescription': 'Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the mental health score of the SF-12 pre and post intervention.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in perceptions of health and quality of life in domains that include social, physical, emotional and mental functions. The SF-12 has 12 items; two component scores capturing perceptions of mental and physical function can be derived. The Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores are calculated using 12 questions with a range of 0-100 (zero indicating the poorest level of health measured and 100 indicating the highest).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Falls.', 'timeFrame': 'Baseline and 12 Months', 'description': 'Presence and number of falls over 12 months from baseline.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Mild Cognitive Impairment (MCI)', 'timeFrame': 'Baseline and 2 Months', 'description': 'Progression in cognitive impairment from normal cognitive function at baseline to MCI.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Dementia', 'timeFrame': 'Baseline and 2 Months', 'description': 'Progression in cognitive impairment from baseline normal cognitive function to dementia.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Motoric Cognitive Risk Syndrome (MCR)', 'timeFrame': 'Baseline and 2 Months', 'description': 'Progression in cognitive impairment from baseline normal cognitive function to MCR.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Cognitively Impaired', 'timeFrame': 'Baseline and 2 Months', 'description': 'Progression in cognitive impairment from baseline normal cognitive function to cognitive impairment defined as presence of incident MCI, dementia, or MCR.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'FG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}], 'periods': [{'title': '9 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '191'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Study suspended due to COVID-19 pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}, {'title': '6 Month', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '40'}]}]}, {'title': '12 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Remediation', 'description': "An individualized computerized cognitive remediation program.\n\nCognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation."}, {'id': 'BG001', 'title': 'Active Control', 'description': 'Individualized computer based exposure and interactive health education classes.\n\nActive Control: Computer, multimedia and group based health education programs.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.94', 'spread': '5.66', 'groupId': 'BG000'}, {'value': '77.18', 'spread': '5.61', 'groupId': 'BG001'}, {'value': '77.03', 'spread': '5.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', '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': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', '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': '93', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gait Speed, cm/s', 'classes': [{'categories': [{'measurements': [{'value': '75.82', 'spread': '17.73', 'groupId': 'BG000'}, {'value': '75.92', 'spread': '16.81', 'groupId': 'BG001'}, {'value': '75.87', 'spread': '17.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Gait speed during normal walking.', 'unitOfMeasure': 'centimeters per second', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-16', 'size': 11350687, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-03T14:17', 'hasProtocol': True}, {'date': '2020-02-27', 'size': 192801, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-02-03T14:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2015-08-17', 'resultsFirstSubmitDate': '2021-03-15', 'studyFirstSubmitQcDate': '2015-10-01', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-12', 'studyFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Geriatric Depression Scale (GDS).', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed).'}, {'measure': 'Rosenberg Self-Esteem Scale.', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in self-esteem assessed using a ten-item Likert-type scale (higher scores are better).'}, {'measure': 'Falls Efficacy Scale.', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in self-efficacy scores (range 0-100). Higher scores indicate less confidence.'}, {'measure': '12-Item Short Form Health Survey (SF-12).', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in perceptions of health and quality of life in domains that include social, physical, emotional and mental functions. The SF-12 has 12 items; two component scores capturing perceptions of mental and physical function can be derived. The Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores are calculated using 12 questions with a range of 0-100 (zero indicating the poorest level of health measured and 100 indicating the highest).'}, {'measure': 'Falls.', 'timeFrame': 'Baseline and 12 Months', 'description': 'Presence and number of falls over 12 months from baseline.'}, {'measure': 'Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Mild Cognitive Impairment (MCI)', 'timeFrame': 'Baseline and 2 Months', 'description': 'Progression in cognitive impairment from normal cognitive function at baseline to MCI.'}, {'measure': 'Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Dementia', 'timeFrame': 'Baseline and 2 Months', 'description': 'Progression in cognitive impairment from baseline normal cognitive function to dementia.'}, {'measure': 'Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Motoric Cognitive Risk Syndrome (MCR)', 'timeFrame': 'Baseline and 2 Months', 'description': 'Progression in cognitive impairment from baseline normal cognitive function to MCR.'}, {'measure': 'Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Cognitively Impaired', 'timeFrame': 'Baseline and 2 Months', 'description': 'Progression in cognitive impairment from baseline normal cognitive function to cognitive impairment defined as presence of incident MCI, dementia, or MCR.'}], 'primaryOutcomes': [{'measure': 'Change in Walking Speed During Single and Dual-task Conditions.', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm of gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system).'}], 'secondaryOutcomes': [{'measure': 'Change in Short Physical Performance Battery (SPPB).', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in mobility measured using the SPPB. The SPPB is comprised of balance, chair rise, and gait speed tests. A score is assigned in each of these three areas (0-4), and summed to obtain an overall summary score (0-12, higher better).'}, {'measure': 'Stride Length.', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in stride length (cm) collected during normal walking and walking while talking conditions on an instrumented walkway.'}, {'measure': 'Gait Variability.', 'timeFrame': 'Baseline and 2 months', 'description': 'Between group difference in change per arm in gait stride length variability, measured in standard deviation units, collected during normal walking and walking while talking on an instrumented walkway. Gait variability is defined as differences in length from one stride to the next.'}, {'measure': 'Variability in Gait Domains', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm in gait domains (summary measures reported as standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal walking and walking while talking. Based on previous findings of gait patterns, pace, rhythm and variation factors are defined (using z-scores based on mean and standard deviation at baseline). Higher values are indicative of better performance for pace and rhythm factors and indicative of worse performance for variation factors.'}, {'measure': 'Number of Participants With Substantial Gait Speed Change.', 'timeFrame': 'Baseline and 2 Months', 'description': 'Substantial gait speed improvement is defined as change of ≥1 standard deviation units from baseline performance in gait speed measured during normal walking and walking while talking conditions.'}, {'measure': 'Flanker Task.', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm on the Flanker task, a measure of speed of processing, attention and inhibitory control. Scoring is based on reaction time in milliseconds (ms) and calculated as the difference in reaction time that it takes a person, on average, to respond to an incongruent minus congruent stimulus. Lower values reflect better outcome.'}, {'measure': 'Digit Symbol Substitution Test.', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm on the Digit Symbol Substitution Test (a subtest of the Wechsler Adult Intelligence Scale - Revised), a measure of attention, transcription and speed of processing. Scoring is based on the total number of correct responses generated during a 90-sec time interval. Scores range from 0-133 with higher scores indicating better performance.'}, {'measure': 'Trail Making Test Form A.', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm on Trail Making Test form A, a timed measure of attention. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis.'}, {'measure': 'Trail Making Test Form B.', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm on Trail Making Test form B, a timed measure of attention, set shifting and processing speed. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis.'}, {'measure': 'Controlled Oral Word Association Test.', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm on the Controlled Oral Word Association Test, a verbal fluency test that measures word generation performance under specified timed phonemic and semantic conditions. Performance measured by the total number of correct words as well as the number of errors. Scores range from 25-41 seconds with higher scores indicating better performance.'}, {'measure': 'Repeatable Battery for the Assessment of Neuropsychological Status.', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change on the Repeatable Battery for the Assessment of Neuropsychological Status, a relatively brief battery that assesses overall level of cognitive function This battery consists of 10 neurocognitive tests measuring memory (immediate and delayed), attention, language, visuospatial abilities and executive functions. Performance is converted to standardized scores derived from a normative sample.'}, {'measure': 'Neuroplasticity.', 'timeFrame': 'Baseline and 2 Months', 'description': 'Changes in prefrontal activation measure using functional near infra-red spectroscopy.'}, {'measure': 'Durability', 'timeFrame': 'Baseline and 6 months', 'description': 'Between group difference in change per arm in gait speed during normal pace and walking while talking conditions measured at six months.'}, {'measure': 'Stair Climbing Time.', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm in mobility and balance assessed during stair climbing, which provides a valid assessment tool for predicting disability. Scores are measured as time in seconds to climb 3 stairs with longer time indicating worse performance. Scores were log transformed prior to analysis.'}, {'measure': 'Disability Scale.', 'timeFrame': 'Baseline and 2 Months', 'description': 'Between group difference in change per arm in mobility assessed by activities of daily living tasks on the Activities of Daily Living-Prevention Instrument. Scores range from 0-45 and higher scores indicate poorer function.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mobility Limitation', 'Motor Activity', 'Difficulty Walking', 'Cognitive Ability General']}, 'referencesModule': {'references': [{'pmid': '20643703', 'type': 'RESULT', 'citation': 'Verghese J, Mahoney J, Ambrose AF, Wang C, Holtzer R. Effect of cognitive remediation on gait in sedentary seniors. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1338-43. doi: 10.1093/gerona/glq127. Epub 2010 Jul 19.'}, {'pmid': '34522910', 'type': 'DERIVED', 'citation': 'Verghese J, Mahoney JR, Ayers E, Ambrose A, Wang C, Holtzer R. Computerised cognitive remediation to enhance mobility in older adults: a single-blind, single-centre, randomised trial. Lancet Healthy Longev. 2021 Sep;2(9):e571-e579. doi: 10.1016/s2666-7568(21)00173-2. Epub 2021 Sep 2.'}, {'pmid': '27813452', 'type': 'DERIVED', 'citation': 'Verghese J, Ayers E, Mahoney JR, Ambrose A, Wang C, Holtzer R. Cognitive remediation to enhance mobility in older adults: the CREM study. Neurodegener Dis Manag. 2016 Dec;6(6):457-466. doi: 10.2217/nmt-2016-0034. Epub 2016 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to conduct a single-blind randomized clinical trial to test the efficacy of a computerized cognitive remediation intervention program on improving locomotion in sedentary seniors, a group at an especially high risk for disability. The hypothesis is that executive functions will respond to the cognitive remediation program and in turn enhance locomotion.', 'detailedDescription': "Emerging evidence indicates that Executive Functions play an important role in maintaining locomotion in aging and preventing mobility disabilities. However, use of cognitive training programs to improve executive functions as a strategy to increase mobility has not been explored. Exciting results from the preliminary study support the efficacy and feasibility of the cognitive remediation approach to improve locomotion in older adults.\n\nThe premise of this clinical trial is that disability among seniors is a potentially preventable chronic condition rather than an irreversible consequence of aging and disease. The investigators proposed novel approach to locomotion has the potential to shift treatment paradigms in the field of disability by introducing cognitive approaches to mobility that can be applied to prevention and rehabilitation in diverse settings. Through this 'proof of concept' secondary prevention trial the investigators will fill an important gap in knowledge for practicing evidence-based medicine and developing effective interventions for a major health outcome affecting a substantial proportion of the U.S. aging population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adults aged 70 and older, residing in the community.\n2. Plan to be in area for next year.\n3. Able to speak English at a level sufficient to undergo our cognitive assessment battery.\n4. Ambulatory. Subjects are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit.\n5. Gait velocity ≤1 m/s.\n6. Short Physical Performance Battery score ≤9.\n\nExclusion Criteria:\n\n1. Presence of dementia identified by any one of the following: Telephone based Memory Impairment Screen score (T-MIS) of \\<5, Alzheimer's Disease 8 (AD8) ≥ 2. Or dementia diagnosed by baseline cognitive assessment.\n2. Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease.\n3. Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent subjects from completing mobility tests. Presence of arthritis will not be used to exclude subjects if they can complete the mobility tasks.\n4. Any medical condition or chronic medication use (e.g., neuroleptics) that will compromise safety or affect cognitive functioning or terminal illness with life expectancy less than 12 months.\n5. Presence of progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS).\n6. Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g. hip or knee replacement) and that prevent subjects from completing mobility tests or plans for surgery affecting mobility in the next 6 months.\n7. Severe auditory or visual loss.\n8. Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols.\n9. Living in nursing home.\n10. Participation in other intervention trial or observational studies. -"}, 'identificationModule': {'nctId': 'NCT02567227', 'acronym': 'CREM', 'briefTitle': 'Cognitive Remediation to Improve Mobility in Sedentary Seniors', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Cognitive Intervention to Improve Simple and Complex Walking', 'orgStudyIdInfo': {'id': '2015-4752'}, 'secondaryIdInfos': [{'id': 'R01AG050448-01', 'link': 'https://reporter.nih.gov/quickSearch/R01AG050448-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Remediation', 'description': 'An individualized computerized cognitive remediation program.', 'interventionNames': ['Other: Cognitive Remediation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active control', 'description': 'Individualized computer based exposure and interactive health education classes.', 'interventionNames': ['Other: Active Control']}], 'interventions': [{'name': 'Cognitive Remediation', 'type': 'OTHER', 'description': "This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.", 'armGroupLabels': ['Cognitive Remediation']}, {'name': 'Active Control', 'type': 'OTHER', 'description': 'Computer, multimedia and group based health education programs.', 'armGroupLabels': ['Active control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Joe Verghese, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}, {'name': 'Roee Holtzer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}