Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-22 @ 11:30 AM
Study NCT ID:
NCT02136368
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2014-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body and Brain Exercise for Older Adults With Memory Complaints
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016059', 'term': 'Range of Motion, Articular'}], 'ancestors': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-05-09', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prosaccade reaction time in response to flash of light.', 'timeFrame': '6 months', 'description': 'The reaction time of the eye when instructed to look toward a flash of light.'}, {'measure': 'Change in blood flow to the pre-frontal cortex in response to a randomly selected cognitive task.', 'timeFrame': '6 months', 'description': 'Neuroimaging assessment with functional magnetic resonance imaging'}, {'measure': 'Antisaccade reaction time in response to flash of light.', 'timeFrame': '6 months', 'description': 'The reaction time of the eye when instructed to look away from a flash of light.'}, {'measure': 'Change in blood flow to the parietal cortex in response to a randomly selected cognitive task.', 'timeFrame': '6 months', 'description': 'Neuroimaging assessment with functional magnetic resonance imaging'}], 'primaryOutcomes': [{'measure': 'Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks', 'timeFrame': '6 months', 'description': 'To assess global cognitive function'}], 'secondaryOutcomes': [{'measure': 'Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks', 'timeFrame': '12 months', 'description': 'To assess global cognitive function'}, {'measure': 'Gait variability (stride time) under dual-task conditions', 'timeFrame': '6 & 12 months', 'description': 'Gait variability is the stride-to-stride fluctuations of the way someone walks and will be calculated as the coefficient of variation of step length (SD/mean x100). Measured with GAITRite system.'}, {'measure': 'Gait variability (stride time) under single-task conditions', 'timeFrame': '6 & 12 months', 'description': 'Gait variability is the stride-to-stride fluctuations of the way someone walks and will be calculated as the coefficient of variation of step length (SD/mean x100). Measured with GAITRite system.'}, {'measure': 'Gait velocity (speed) under dual-task conditions', 'timeFrame': '6 & 12 months', 'description': 'Average walking speed (gait velocity) measured with the GAITRite system'}, {'measure': 'Gait velocity (speed) under single-task conditions', 'timeFrame': '6 & 12 months', 'description': 'Average walking speed (gait velocity) measured with the GAITRite system'}, {'measure': 'Step length (average) under dual-task conditions', 'timeFrame': '6 & 12 months', 'description': 'Mean step length calculated from GAITRite system'}, {'measure': 'Step length (average) under single-task conditions', 'timeFrame': '6 & 12 months', 'description': 'Mean step length calculated from GAITRite system'}, {'measure': 'Carotid Artery Compliance', 'timeFrame': '6 & 12 months', 'description': 'Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).'}, {'measure': 'Carotid Artery Intima-media thickness', 'timeFrame': '6 & 12 months', 'description': 'Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).'}, {'measure': 'Ambulatory Systolic Blood Pressure', 'timeFrame': '6 & 12 months', 'description': 'Average systolic blood pressure over a 24 hour time period.'}, {'measure': 'Clinic Systolic Blood Pressure', 'timeFrame': '6 & 12 months', 'description': 'Average systolic blood pressure from in clinic final 2 (out of 3) readings'}, {'measure': 'Ambulatory Diastolic Blood Pressure', 'timeFrame': '6 & 12 months', 'description': 'Average diastolic blood pressure over a 24 hour time period.'}, {'measure': 'Clinic Diastolic Blood Pressure', 'timeFrame': '6 & 12 months', 'description': 'Average diastolic blood pressure from in clinic final 2 (out of 3) readings'}, {'measure': 'Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery', 'timeFrame': '6 & 12 months'}, {'measure': 'Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery', 'timeFrame': '6 & 12 months'}, {'measure': 'Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery', 'timeFrame': '6 & 12 months'}, {'measure': 'Total balance score', 'timeFrame': '6 & 12 months', 'description': 'Total score calculated from the the Fullerton Advanced Balance scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['older adults', 'multiple-modality exercise', 'mind-motor exercise', 'self-reported cognitive complaints', 'global cognitive functioning', 'mobility', 'vascular function', 'sensorimotor function', 'brain imaging', 'community-based research', 'subjective cognitive complaints'], 'conditions': ['Cognitive Ability, General']}, 'referencesModule': {'references': [{'pmid': '32158386', 'type': 'DERIVED', 'citation': 'Boa Sorte Silva NC, Nagamatsu LS, Gill DP, Owen AM, Petrella RJ. Memory Function and Brain Functional Connectivity Adaptations Following Multiple-Modality Exercise and Mind-Motor Training in Older Adults at Risk of Dementia: An Exploratory Sub-Study. Front Aging Neurosci. 2020 Feb 25;12:22. doi: 10.3389/fnagi.2020.00022. eCollection 2020.'}, {'pmid': '26772171', 'type': 'DERIVED', 'citation': 'Gregory MA, Gill DP, Shellington EM, Liu-Ambrose T, Shigematsu R, Zou G, Shoemaker K, Owen AM, Hachinski V, Stuckey M, Petrella RJ. Group-based exercise and cognitive-physical training in older adults with self-reported cognitive complaints: The Multiple-Modality, Mind-Motor (M4) study protocol. BMC Geriatr. 2016 Jan 16;16:17. doi: 10.1186/s12877-016-0190-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether an exercise class with a cognitive (or brain) training component was more effective than a usual combined aerobic and resistance exercise class for older adults with cognitive complaints (such as concerns about changes in memory or thinking skills). It is hypothesized that the group randomized to the exercise class that includes additional brain training will have greater improvements in brain health.', 'detailedDescription': "Older adults with self-reported cognitive complaints (CCs) may be at increased risk for the development of Alzheimer's disease and dementia. Cognitive decline in older adults, particularly reduced memory and executive function is associated with functional decline, institutionalization, and increased health care costs. Similarly, cardiovascular risk factors have been associated with cognitive and functional impairment in aging. Aerobic exercise has been shown to improve vascular function and blood flow in the brain's prefrontal cortex. In turn, resistance training can produce functional changes within distinct cortical regions during the encoding and recall of association tasks and has been shown to increase circulating neural growth factors (i.e., a proposed mechanism by which cognition may be preserved or improved in old age). Recent evidence also suggests that cognitive training may improve the cognitive performance of older adults.\n\nTherefore, we will investigate the impact of a combined exercise program (multi-modality exercise; M2) compared to a combined exercise program with a cognitive component (multi-modality, mind-motor exercise; M4) on cognition, cognitive-motor, mobility, neural functioning and vascular outcomes in older adults with cognitive complaints. Community-based exercise programs for older adults provide widespread access, are relatively inexpensive, and provide opportunities for social interaction.\n\nThe primary purpose of this study is to compare the effects of the M2 and M4 exercise programs on brain health. This study will also examine the effects of the different exercise programs on cardiovascular risk factors and mobility. In a subset of participants, cognitive-motor and neural functioning outcomes will be examined."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 55 years or older\n* self-reported cognitive complaint (defined as answering yes to the question "Do you feel like your memory or thinking skills have gotten worse recently?).\n* independent on instrumental activities of daily living\n\nExclusion Criteria:\n\n* Probable Dementia (i.e., diagnosis OR Mini-Mental State Examination score \\<24)\n* Other neurological conditions or major psychiatric disorders (i.e., Parkinson\'s disease; bipolar disorder)\n* Previous history of severe cardiovascular conditions (i.e., myocardial infarction or stroke \\<1-year ago; end stage congestive heart failure; end stage renal disease)\n* Severe sensory impairment (i.e., blind)\n* Significant orthopedic conditions (i.e., severe osteoarthritis)\n* Clinical depression (determined via \\>=16 on the Center for Epidemiologic Studies - Depression Scale AND review by primary study physician)\n* Have blood pressure \\>180/100 mmHg or \\<100/60 mmHg\n* Unable to comprehend questionnaire material\n* Any other factors that could potentially limit ability to fully participate in the intervention'}, 'identificationModule': {'nctId': 'NCT02136368', 'briefTitle': 'Body and Brain Exercise for Older Adults With Memory Complaints', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'A Combined Exercise Program Plus Cognitive Training for Older Adults With Self-reported Cognitive Complaints: The Multi-modal, Mind-motor (M4) Study', 'orgStudyIdInfo': {'id': 'M4W18858'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-Modal, Mind Motor Exercise (M4)', 'description': 'Attend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of mind-motor exercise.', 'interventionNames': ['Behavioral: Multi-modal exercise', 'Behavioral: Mind-Motor Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multi-Modal Exercise (M2)', 'description': 'Attend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of balance and range of motion exercises.', 'interventionNames': ['Behavioral: Multi-modal exercise', 'Behavioral: Balance and range of motion exercises']}], 'interventions': [{'name': 'Multi-modal exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Exercise intervention'], 'description': 'Community-based group exercise classes following Canadian Centre for Activity and Aging exercise guidelines. Exercise classes consist of 5 min warm-up, 20 min aerobic exercise, 5 min aerobic cool-down, 10 min full-body resistance exercise, 5 min stretching (total 45 min)', 'armGroupLabels': ['Multi-Modal Exercise (M2)', 'Multi-Modal, Mind Motor Exercise (M4)']}, {'name': 'Mind-Motor Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Square Stepping Exercise'], 'description': 'Square Step Exercise involves mimicking a stepping pattern demonstrated by an instructor. The stepping patterns become progressively difficult and involve forward, backward, lateral and diagonal movements on a 250cm long mat with 25cm square grids (15 min).', 'armGroupLabels': ['Multi-Modal, Mind Motor Exercise (M4)']}, {'name': 'Balance and range of motion exercises', 'type': 'BEHAVIORAL', 'description': 'Community-based group exercise designed to improve balance and range of motion of the joints (15 min)', 'armGroupLabels': ['Multi-Modal Exercise (M2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N4V 0B1', 'city': 'Woodstock', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Gymnasium', 'geoPoint': {'lat': 43.13339, 'lon': -80.7497}}], 'overallOfficials': [{'name': 'Robert J Petrella, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Western Ontario'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rob Petrella', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}