Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-29 @ 7:39 AM
Study NCT ID:
NCT04070703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2019-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fuzhongl@ori.org', 'phone': '5414842123', 'title': 'Fuzhong Li', 'organization': 'Oregon Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations of the trial included (a) the lack of a nonexercise control group and (b) participants who were predominately White and well educated which limits the generalizability of these reports.'}}, 'adverseEventsModule': {'timeFrame': 'Events were observed and documented during the 6-month active intervention period.', 'description': 'Data reported in this record is consistent with the definitions described at clinicaltrials.gov', 'eventGroups': [{'id': 'EG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 10, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 10, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 11, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Other events', 'notes': 'events that required no or medical treatment and were non-life threatening (e.g., lower back pain, ankle/muscle soreness or pain without needing medical attention).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Serious event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Montreal Cognitive Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '25.3', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': 'Int Termination', 'categories': [{'measurements': [{'value': '28.4', 'spread': '.2', 'groupId': 'OG000'}, {'value': '27', 'spread': '.2', 'groupId': 'OG001'}, {'value': '25.6', 'spread': '.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0125', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.75', 'paramValue': '2.8', 'ciLowerLimit': '2.1', 'ciUpperLimit': '3.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The co-primary outcome data were analyzed via a Group by Time mixed-effects model with repeated measures on the second factor (i.e., outcome measures assessed at baseline and 6 months. In the presence of a Group by Time interaction effect, pre-specified follow-up pair-wise comparisons were performed to determine between-group differences.'}, {'pValue': '.0125', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.75', 'paramValue': '1.5', 'ciLowerLimit': '.07', 'ciUpperLimit': '2.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'The Montreal Cognitive Assessment scale measures change in global cognitive function from baseline to 6 months. The scale scores range from 0 to 30 points, with higher scores indicating better cognitive functioning.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary outcome data were analyzed via a Group by Time mixed-effects model with repeated measures on the second factor (i.e., outcome measures assessed at baseline and 6 months. In the presence of a Group by Time interaction effect, pre-specified follow-up pair-wise comparisons were performed to determine between-group differences.'}, {'type': 'PRIMARY', 'title': 'Gait Performance Under a Dual-task Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '36.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '36.3', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '36.3', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '15.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '37.5', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.0125', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.75', 'paramValue': '9.9', 'ciLowerLimit': '2.8', 'ciUpperLimit': '16.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.0125', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.75', 'paramValue': '22', 'ciLowerLimit': '12.6', 'ciUpperLimit': '31.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'Assessing change in dual-task ability (measured in seconds) from baseline to 6 months. Change will be assessed via an Instrumental Timed Up\\&Go (iTUG) gait performance (APDM, Inc.) in which the participant is asked to stand up from a chair, walk a 6-m walkway at normal pace (3 m toward a line, turn, and 3 m toward the chair), turn around, and sit down on the chair, with no cognitive task (single-task walking). The participant is then asked to perform the same procedure with a concurrent cognitive task (counting backward by 3s, starting with an odd number, e.g., 81).12 The total walking duration (in seconds) during both 6-meter walks, at normal pace, will be recorded. Lower duration indicates a better outcome.', 'unitOfMeasure': 'second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The co-primary outcome data were analyzed via a Group by Time mixed-effects model with repeated measures on the second factor (i.e., outcome measures assessed at baseline and 6 months. In the presence of a Group by Time interaction effect, pre-specified follow-up pair-wise comparisons were performed to determine between-group differences.'}, {'type': 'SECONDARY', 'title': 'Clinical Dementia Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '1.0', 'spread': '.1', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '.1', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '.1', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '.3', 'spread': '.1', 'groupId': 'OG000'}, {'value': '.6', 'spread': '.1', 'groupId': 'OG001'}, {'value': '.9', 'spread': '.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-.5', 'ciUpperLimit': '-.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.6', 'ciLowerLimit': '-.7', 'ciUpperLimit': '-.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'The Clinical Dementia Rating Scale measures change in cognitive decline from baseline to 6 months. The scale measures six domains of cognitive and functional performance. Scores range from 0 to 3 points in each domain, with a score of 0 indicating no impairment, while a score of 3 signifying severe impairment. Scores from all domains have been averaged to compute the total score reported. In this trial, lower scores indicate less severity in cognitive decline (i.e., improvement from intervention).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of variance examining difference between groups'}, {'type': 'SECONDARY', 'title': 'Domain-specific Cognitive Test - Trail Making - B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '98.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '98.4', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '98', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '72.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '86.2', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '94.2', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.1', 'ciLowerLimit': '-20', 'ciUpperLimit': '-8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22', 'ciLowerLimit': '-28', 'ciUpperLimit': '-16', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'Change in domain-specific cognitive function - executive function (measured in seconds) from baseline to 24 weeks. Trail Making Test assesses attention and executive function. In this test, the participant connects numbers and letters in an alternating progressive sequence, 1 to A, 2 to B, 3 to C, and so on. For parts A and B, scoring is expressed in terms of the time (in seconds) to completion. Lower scores indicate higher executive functioning.', 'unitOfMeasure': 'second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of variance examining difference between groups.'}, {'type': 'SECONDARY', 'title': '4-Stage Balance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '2.6', 'spread': '.1', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '.1', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '.1', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '3.4', 'spread': '.1', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '.1', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.1', 'ciLowerLimit': '-.4', 'ciUpperLimit': '.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.8', 'ciLowerLimit': '.4', 'ciUpperLimit': '1.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'The 4-Stage Balance Test measures change, from baseline to 6 months, in standing four positions balance. Participants attempt to hold four progressively challenging standing positions. The test ends if a position cannot be held for 10 seconds. The number of positions successfully completed is recorded and awarded one point (0-4), with higher score values indicating better balance.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis of variance examining differences between groups.'}, {'type': 'SECONDARY', 'title': 'Backward Digit Span', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '8.3', 'spread': '.2', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '.2', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '.2', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '10.4', 'spread': '.2', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '.2', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '.5', 'ciUpperLimit': '1.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '1.6', 'ciUpperLimit': '2.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': "The Backward Digit Span test assesses memory. The participant is verbally presented with a series of digits (e.g., 6, 2, 9, 7) at a rate of one digit per second and is required to repeat them verbatim. If the participant succeeds, he/she is given a longer list (e.g., 5, 3, 8, 1, 6). The number of digits increases by one until the participant consecutively fails two trials of the same digit span length. The length of the longest list a person can remember is that person's digit span. In this test, the participant is required to repeat the digits in reverse. The participant receives 1 point for each correct answer. The Backward Digit Span test scores range from 0 to 32, with higher scores indicating better memory.", 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Verbal Fluency Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '14', 'spread': '.2', 'groupId': 'OG000'}, {'value': '14', 'spread': '.2', 'groupId': 'OG001'}, {'value': '14', 'spread': '.2', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '19', 'spread': '.3', 'groupId': 'OG000'}, {'value': '19', 'spread': '.3', 'groupId': 'OG001'}, {'value': '15', 'spread': '.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.9', 'ciLowerLimit': '-.4', 'ciUpperLimit': '2.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '3.1', 'ciUpperLimit': '5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'The Verbal Fluency Test assesses verbal fluency and executive function of cognitive function. The participant is asked to generate the names of as many animals as possible in 60 seconds. High scores (i.e., more animals names generated) in this measure indicate better performance (i.e., better verbal fluency and executive function).', 'unitOfMeasure': 'number of animals', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Timed up and go', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '12.6', 'spread': '.2', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '.2', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '.3', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '10.8', 'spread': '.2', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '.2', 'groupId': 'OG001'}, {'value': '12.6', 'spread': '.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.3', 'ciLowerLimit': '-.3', 'ciUpperLimit': '.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '-1.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'The Timed up and go (TUG) measure is recorded in seconds (the time taken by an individual to stand up from a standard armless chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down). Lower scores indicate better performance.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '30-Second Chair Stands Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '11', 'spread': '.2', 'groupId': 'OG000'}, {'value': '11', 'spread': '.2', 'groupId': 'OG001'}, {'value': '11', 'spread': '.3', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '13', 'spread': '.4', 'groupId': 'OG000'}, {'value': '13', 'spread': '.4', 'groupId': 'OG001'}, {'value': '11', 'spread': '.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.4', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '.8', 'ciUpperLimit': '2.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'The 30-Second Chair Stands Test is used to measure change from baseline to 6 months in physical performance. The Test involves repeatedly standing up from and sitting down in a chair as many times as possible within 30 seconds, with high (count) scores indicating better performance (i.e., leg strength).', 'unitOfMeasure': 'chair stands', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Forward Digit Span Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '12.8', 'spread': '.1', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '.1', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '.1', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '10.4', 'spread': '.2', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '.2', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.5', 'ciLowerLimit': '-.1', 'ciUpperLimit': '1.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '1.6', 'ciUpperLimit': '2.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': "The Forward Digit Span test measures attention/concentration (in points) with high scores indicating better attention. The participant is verbally presented with a series of digits (e.g., 6, 2, 9, 7) at a rate of one digit per second and is required to repeat them verbatim. If the participant succeeds, he/she is given a longer list (e.g., 5, 3, 8, 1, 6). The number of digits increases by one until the participant consecutively fails two trials of the same digit span length. The length of the longest list a person can remember is that person's digit span.", 'unitOfMeasure': 'point', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis of variance was conducted examining differences between groups'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '8.2', 'spread': '.3', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '.3', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '.3', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '5.2', 'spread': '.3', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '.3', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.1', 'ciLowerLimit': '-.7', 'ciUpperLimit': '.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '-1.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'Change in sleep quality from baseline to 24 weeks. The Pittsburgh Sleep Quality Index (PSQI) includes seven indices: subjective quality, latency (i.e., time needed to fall asleep), duration (i.e., number of hours of actual sleep per night), efficiency (i.e., total sleep time divided by time in bed, converted to a score of 0-3), sleep disturbances (e.g., waking up in the middle of the night and the like), use of sleeping medication, and daytime dysfunction (e.g., having difficulty staying awake during the day). Each of the component scores ranges from 0 to 3, with the PSQI global score ranging from 0 to 21 points, with higher scores indicating poorer sleep quality.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Depression - Geriatric Depression Scale (GDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '3.5', 'spread': '.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '.3', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '.3', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '1.6', 'spread': '.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '.2', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.5', 'ciLowerLimit': '-.3', 'ciUpperLimit': '1.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '-.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'Change in depression from baseline to 24 weeks. The Geriatric Depression Scale (GDS) score ranges from 0 to 15 with higher scores indicated increased depression symptoms and scores higher than 5 indicative of depression.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Activity and Movement Confidence Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '82', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '82.6', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '81.6', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '89.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '88.3', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '83.1', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-.4', 'ciUpperLimit': '2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '3.1', 'ciUpperLimit': '7.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': "The Activity and Movement Confidence Scales measure a person's movement confidence. In this study it assesses change in activity and movement confidence from baseline to 24 weeks. The total score ranges from 0 to 100 with higher scores indicating higher confidence.", 'unitOfMeasure': 'point', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of variance was conducted to examine differences between groups'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life - EuroQol.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '.76', 'spread': '.01', 'groupId': 'OG000'}, {'value': '.77', 'spread': '.01', 'groupId': 'OG001'}, {'value': '.77', 'spread': '.01', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '.90', 'spread': '.01', 'groupId': 'OG000'}, {'value': '.90', 'spread': '.01', 'groupId': 'OG001'}, {'value': '.76', 'spread': '.01', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.0', 'ciLowerLimit': '-.04', 'ciUpperLimit': '.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.07', 'ciLowerLimit': '.03', 'ciUpperLimit': '.11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'The Quality of Life - EuroQol. scale assesses quality of life. Change in quality of life from baseline to 24 weeks. The EQ-5D-3L version will be used that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The scores of EQ-5D-3L will be averaged to generate a single utility value ranging from 1.00 for the "best health" state to -0.594 for the "worst health" state, where a score of 0 is indicative of death, and scores less than 0 are considered as "worse than death." Participants who die during the trial period will be registered as 0 in utility terms for the assessment period from when the death occurred.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'International Physical Activity Questionnaire (IPAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '146', 'spread': '12', 'groupId': 'OG000'}, {'value': '145', 'spread': '12', 'groupId': 'OG001'}, {'value': '145.8', 'spread': '12.3', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '273', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '267.9', 'spread': '12', 'groupId': 'OG001'}, {'value': '147.6', 'spread': '12.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '-2', 'ciUpperLimit': '6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '125.5', 'ciLowerLimit': '84', 'ciUpperLimit': '166', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months', 'description': 'The International Physical Activity Questionnaire (IPAQ) measures the level of moderate and vigorous physical activity (MVPA) (measured in minutes) with high scores indicating high level of physical activity. This measure asks participants to report how often (measured in days) and how much time (in minutes) over the previous week they participated in physical activity or exercise of any moderate (ex. gardening, cleaning, etc.) or vigorous (ex. heavy lifting, jogging/running or fast bicycling, etc.) intensity that lasted at least 10 minutes at a time. The activities to be asked during the post-intervention follow-up (at 6 months) will not include the time spent in attending the assigned exercise programs in the study. Total weekly duration of MVPA, measured in minutes, are calculated by multiplying frequency and duration (vigorous activity weighted by 2) to form a total weighted amount of MVPA min/week.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of variance was conducted to examine differences between groups.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Everyday Cognition Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'OG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '2', 'spread': '.04', 'groupId': 'OG000'}, {'value': '2', 'spread': '.04', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '.04', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '1.2', 'spread': '.1', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '.1', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.2', 'ciLowerLimit': '-.3', 'ciUpperLimit': '-.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.5', 'ciLowerLimit': '-.7', 'ciUpperLimit': '-.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'The Everyday Cognition Scale measures change from baseline to 6 months in everyday cognitive function. Sub scale scores will be averaged to create a total score. Total scores range 1 to 4, with higher scores indicating better everyday cognitive function.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'FG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'FG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '107'}, {'groupId': 'FG002', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitively Enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'BG001', 'title': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'BG002', 'title': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.\n\nThe Go for Exercise \\& Healthy Aging Project: Exercise and Cognition'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76', 'spread': '5', 'groupId': 'BG000'}, {'value': '76', 'spread': '5', 'groupId': 'BG001'}, {'value': '76', 'spread': '5', 'groupId': 'BG002'}, {'value': '76', 'spread': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Age measured in year', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '212', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '29', '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': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were recruited from 81 cities/towns across 25 states in the U.S. The detailed number from each state is not shown.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-12', 'size': 1120859, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-02T14:09', 'hasProtocol': True}, {'date': '2024-09-12', 'size': 454815, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-02T14:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2019-08-26', 'resultsFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-22', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'baseline, 6 months', 'description': 'Change in sleep quality from baseline to 24 weeks. The Pittsburgh Sleep Quality Index (PSQI) includes seven indices: subjective quality, latency (i.e., time needed to fall asleep), duration (i.e., number of hours of actual sleep per night), efficiency (i.e., total sleep time divided by time in bed, converted to a score of 0-3), sleep disturbances (e.g., waking up in the middle of the night and the like), use of sleeping medication, and daytime dysfunction (e.g., having difficulty staying awake during the day). Each of the component scores ranges from 0 to 3, with the PSQI global score ranging from 0 to 21 points, with higher scores indicating poorer sleep quality.'}, {'measure': 'Depression - Geriatric Depression Scale (GDS)', 'timeFrame': 'baseline, 6 months', 'description': 'Change in depression from baseline to 24 weeks. The Geriatric Depression Scale (GDS) score ranges from 0 to 15 with higher scores indicated increased depression symptoms and scores higher than 5 indicative of depression.'}, {'measure': 'Activity and Movement Confidence Scales', 'timeFrame': 'baseline, 6 months', 'description': "The Activity and Movement Confidence Scales measure a person's movement confidence. In this study it assesses change in activity and movement confidence from baseline to 24 weeks. The total score ranges from 0 to 100 with higher scores indicating higher confidence."}, {'measure': 'Quality of Life - EuroQol.', 'timeFrame': 'baseline, 6 months', 'description': 'The Quality of Life - EuroQol. scale assesses quality of life. Change in quality of life from baseline to 24 weeks. The EQ-5D-3L version will be used that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The scores of EQ-5D-3L will be averaged to generate a single utility value ranging from 1.00 for the "best health" state to -0.594 for the "worst health" state, where a score of 0 is indicative of death, and scores less than 0 are considered as "worse than death." Participants who die during the trial period will be registered as 0 in utility terms for the assessment period from when the death occurred.'}, {'measure': 'International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'baseline and 6 months', 'description': 'The International Physical Activity Questionnaire (IPAQ) measures the level of moderate and vigorous physical activity (MVPA) (measured in minutes) with high scores indicating high level of physical activity. This measure asks participants to report how often (measured in days) and how much time (in minutes) over the previous week they participated in physical activity or exercise of any moderate (ex. gardening, cleaning, etc.) or vigorous (ex. heavy lifting, jogging/running or fast bicycling, etc.) intensity that lasted at least 10 minutes at a time. The activities to be asked during the post-intervention follow-up (at 6 months) will not include the time spent in attending the assigned exercise programs in the study. Total weekly duration of MVPA, measured in minutes, are calculated by multiplying frequency and duration (vigorous activity weighted by 2) to form a total weighted amount of MVPA min/week.'}, {'measure': 'Everyday Cognition Scale', 'timeFrame': 'baseline, 6 months', 'description': 'The Everyday Cognition Scale measures change from baseline to 6 months in everyday cognitive function. Sub scale scores will be averaged to create a total score. Total scores range 1 to 4, with higher scores indicating better everyday cognitive function.'}], 'primaryOutcomes': [{'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'baseline, 6 months', 'description': 'The Montreal Cognitive Assessment scale measures change in global cognitive function from baseline to 6 months. The scale scores range from 0 to 30 points, with higher scores indicating better cognitive functioning.'}, {'measure': 'Gait Performance Under a Dual-task Condition', 'timeFrame': 'baseline, 6 months', 'description': 'Assessing change in dual-task ability (measured in seconds) from baseline to 6 months. Change will be assessed via an Instrumental Timed Up\\&Go (iTUG) gait performance (APDM, Inc.) in which the participant is asked to stand up from a chair, walk a 6-m walkway at normal pace (3 m toward a line, turn, and 3 m toward the chair), turn around, and sit down on the chair, with no cognitive task (single-task walking). The participant is then asked to perform the same procedure with a concurrent cognitive task (counting backward by 3s, starting with an odd number, e.g., 81).12 The total walking duration (in seconds) during both 6-meter walks, at normal pace, will be recorded. Lower duration indicates a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Clinical Dementia Rating Scale', 'timeFrame': 'baseline, 6 months', 'description': 'The Clinical Dementia Rating Scale measures change in cognitive decline from baseline to 6 months. The scale measures six domains of cognitive and functional performance. Scores range from 0 to 3 points in each domain, with a score of 0 indicating no impairment, while a score of 3 signifying severe impairment. Scores from all domains have been averaged to compute the total score reported. In this trial, lower scores indicate less severity in cognitive decline (i.e., improvement from intervention).'}, {'measure': 'Domain-specific Cognitive Test - Trail Making - B', 'timeFrame': 'baseline, 6 months', 'description': 'Change in domain-specific cognitive function - executive function (measured in seconds) from baseline to 24 weeks. Trail Making Test assesses attention and executive function. In this test, the participant connects numbers and letters in an alternating progressive sequence, 1 to A, 2 to B, 3 to C, and so on. For parts A and B, scoring is expressed in terms of the time (in seconds) to completion. Lower scores indicate higher executive functioning.'}, {'measure': '4-Stage Balance Test', 'timeFrame': 'baseline, 6 months', 'description': 'The 4-Stage Balance Test measures change, from baseline to 6 months, in standing four positions balance. Participants attempt to hold four progressively challenging standing positions. The test ends if a position cannot be held for 10 seconds. The number of positions successfully completed is recorded and awarded one point (0-4), with higher score values indicating better balance.'}, {'measure': 'Backward Digit Span', 'timeFrame': 'baseline, 6 months', 'description': "The Backward Digit Span test assesses memory. The participant is verbally presented with a series of digits (e.g., 6, 2, 9, 7) at a rate of one digit per second and is required to repeat them verbatim. If the participant succeeds, he/she is given a longer list (e.g., 5, 3, 8, 1, 6). The number of digits increases by one until the participant consecutively fails two trials of the same digit span length. The length of the longest list a person can remember is that person's digit span. In this test, the participant is required to repeat the digits in reverse. The participant receives 1 point for each correct answer. The Backward Digit Span test scores range from 0 to 32, with higher scores indicating better memory."}, {'measure': 'Verbal Fluency Test', 'timeFrame': 'baseline, 6 months', 'description': 'The Verbal Fluency Test assesses verbal fluency and executive function of cognitive function. The participant is asked to generate the names of as many animals as possible in 60 seconds. High scores (i.e., more animals names generated) in this measure indicate better performance (i.e., better verbal fluency and executive function).'}, {'measure': 'Timed up and go', 'timeFrame': 'baseline, 6 months', 'description': 'The Timed up and go (TUG) measure is recorded in seconds (the time taken by an individual to stand up from a standard armless chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down). Lower scores indicate better performance.'}, {'measure': '30-Second Chair Stands Test', 'timeFrame': 'baseline, 6 months', 'description': 'The 30-Second Chair Stands Test is used to measure change from baseline to 6 months in physical performance. The Test involves repeatedly standing up from and sitting down in a chair as many times as possible within 30 seconds, with high (count) scores indicating better performance (i.e., leg strength).'}, {'measure': 'Forward Digit Span Test', 'timeFrame': 'baseline, 6 months', 'description': "The Forward Digit Span test measures attention/concentration (in points) with high scores indicating better attention. The participant is verbally presented with a series of digits (e.g., 6, 2, 9, 7) at a rate of one digit per second and is required to repeat them verbatim. If the participant succeeds, he/she is given a longer list (e.g., 5, 3, 8, 1, 6). The number of digits increases by one until the participant consecutively fails two trials of the same digit span length. The length of the longest list a person can remember is that person's digit span."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive function', 'mild cognitive impairment', 'Tai Ji Quan'], 'conditions': ['Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '37903365', 'type': 'BACKGROUND', 'citation': 'Li F, Harmer P, Eckstrom E, Fitzgerald K, Winters-Stone K. Clinical Effectiveness of Cognitively Enhanced Tai Ji Quan Training on Global Cognition and Dual-Task Performance During Walking in Older Adults With Mild Cognitive Impairment or Self-Reported Memory Concerns : A Randomized Controlled Trial. Ann Intern Med. 2023 Nov;176(11):1498-1507. doi: 10.7326/M23-1603. Epub 2023 Oct 31.'}, {'pmid': '39688866', 'type': 'DERIVED', 'citation': 'Li F, Harmer P, Eckstrom E, Winters-Stone K. Physical Activity Engagement After Tai Ji Quan Intervention Among Older Adults With Mild Cognitive Impairment or Memory Concerns: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450457. doi: 10.1001/jamanetworkopen.2024.50457.'}, {'pmid': '35078407', 'type': 'DERIVED', 'citation': 'Li F, Harmer P, Fitzgerald K, Winters-Stone K. A cognitively enhanced online Tai Ji Quan training intervention for community-dwelling older adults with mild cognitive impairment: A feasibility trial. BMC Geriatr. 2022 Jan 25;22(1):76. doi: 10.1186/s12877-021-02747-0.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/37903365/', 'label': 'published article'}]}, 'descriptionModule': {'briefSummary': 'To determine the efficacy of a cognitively enhanced exercise intervention - Tai Ji Quan: Moving to Maintain Brain Health in improving global cognitive function and dual-task ability in older adults with mild cognitive impairment.', 'detailedDescription': 'The primary aim of the study is to determine the efficacy of a cognitively enhanced exercise intervention - Tai Ji Quan: Moving to Maintain Brain Health, relative to a standard Tai Ji Quan intervention and an exercise stretching control, in improving global cognitive function and dual-task ability among community-dwelling older adults with amnestic mild cognitive impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complaint of memory loss\n* clinical dementia rating (CDR) scale score ≤0.5\n* having normal general cognitive function screened, with MMSE ≥24\n* capable of exercising safely, as determined by a healthcare provider\n* willingness to be randomly assigned to an intervention condition and complete the 24-week intervention and 6-month follow-up\n\nExclusion Criteria:\n\n* having medical conditions likely to compromise survival, such as metastatic cancer, or render a participant unable to engage in physical activity, such as severe cardiac failure\n* participating in any type of Tai Ji Quan or daily and/or structured vigorous physical activity (i.e., brisk walking for exercise 30 minutes or longer at a time, or engaging in muscle-strengthening activities, e.g., weight lifting on 3 or more days per week 3 months prior to the study)'}, 'identificationModule': {'nctId': 'NCT04070703', 'briefTitle': 'Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Research Institute'}, 'officialTitle': 'Efficacy of Adapted Tai Ji Quan to Slow Cognitive Decline in Older Adults', 'orgStudyIdInfo': {'id': 'AG059546'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitively enhanced Tai Ji Quan', 'description': 'Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.', 'interventionNames': ['Behavioral: The Go for Exercise & Healthy Aging Project']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Tai Ji Quan', 'description': 'Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.', 'interventionNames': ['Behavioral: The Go for Exercise & Healthy Aging Project']}, {'type': 'SHAM_COMPARATOR', 'label': 'Stretching', 'description': 'Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.', 'interventionNames': ['Behavioral: The Go for Exercise & Healthy Aging Project']}], 'interventions': [{'name': 'The Go for Exercise & Healthy Aging Project', 'type': 'BEHAVIORAL', 'description': 'Exercise and Cognition', 'armGroupLabels': ['Cognitively enhanced Tai Ji Quan', 'Standard Tai Ji Quan', 'Stretching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97403', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Research Institute', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Fuzhong Li, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual level data in this study will not be shared with others for reasons of confidentiality. However, a dataset with identifiable private information removed may be made available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}