Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT03805620
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2019-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Combined Physical-cognitive Training on Cognitive Function in MCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-25', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-13', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "change from baseline Alzheimer's Disease Assessment- cognitive subscale at 3 months", 'timeFrame': '3 months', 'description': "Alzheimer's Disease Assessment-cognitive subscale will be assessed at baseline and 3 months. The total scores range from 0-70, with higher scores (≥ 18) indicating greater cognitive impairment."}, {'measure': 'change from baseline Rey auditory verbal learning score at 3 months', 'timeFrame': '3 months', 'description': 'Memory will be assessed using Rey auditory verbal learning test.'}, {'measure': 'change from baseline Trail Making B-A score at 3 months', 'timeFrame': '3 months', 'description': 'Executive function will be assessed using Trail Making Test part B-A.'}, {'measure': 'change from baseline brain-derived neurotrophic factor level at 3 months', 'timeFrame': '3 months', 'description': 'Level of plasma brain-derived neurotrophic factor (BDNF) will be determined.'}], 'secondaryOutcomes': [{'measure': 'change from baseline Digit Span score at 3 months', 'timeFrame': '3 months', 'description': 'Attention will be assessed using Digit Span forward-backward test.'}, {'measure': 'change from baseline stepping response time at 3 months', 'timeFrame': '3 months', 'description': 'Processing speed will be measured using stepping response time.'}, {'measure': 'change from baseline time to complete Timed Up and Go at 3 months', 'timeFrame': '3 months', 'description': 'Functional ability will be assessed using time to complete Timed Up and Go (TUG).'}, {'measure': 'change from baseline physiological profile assessment score at 3 months', 'timeFrame': '3 months', 'description': 'Fall risk will be assessed using the physiological profile assessment. The test consists of five sensorimotor and balance measures including visual contrast sensitivity, proprioception, quadriceps muscle strength, hand reaction time, and postural sway. The five PPA components are weighted to compute a composite z-score distribution with high scores indicating increased fall risk.'}, {'measure': 'change from baseline cellular oxidative stress level at 3 months', 'timeFrame': '3 months', 'description': 'Mitochondrial function will be determined from cellular oxidative stress level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mild cognitive impairment', 'combined physical-cognitive training', 'BDNF', 'mitochondrial function', 'cognitive function'], 'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'The present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. It is hypothesized that: 1) the combined physical-cognitive training program will be superior to the physical and cognitive training program alone; and 2) the degree of cognitive improvement will be positively correlated with the improvement of plasma BDNF and mitochondrial function.', 'detailedDescription': 'Recent research suggests that the benefits of combined physical-cognitive training may be greater than either physical or cognitive training alone. Nevertheless, this synergistic effect has been demonstrated mainly in cognitively intact older adults. Studies examining the effects of combined physical-cognitive training in older adults with MCI are scarce and show mixed results. Moreover, few studies have determined the effects of the combined training on peripheral brain-derived neurotrophic factor (BDNF) and mitochondrial function. Thus, the present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. The present study will provide insight into the interplay among the training program, peripheral BDNF concentration, mitochondrial function, and cognitive function. Importantly, the findings will have clinical implication regarding the training program that is feasible and effective in improving cognitive function of older adults with MCI which ultimately will have great impact on public health as this population is at high risk of progression to AD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* meet criteria for mNCD (mild neurocognitive disorders), previously known as MCI, based on the recent DSM-V (Diagnostic Statistical Manual-V) criteria\n* comprehend instructions and willing to participate\n* able to comply with the study schedule and procedures\n* not taking any medications for their cognition and not planning to start medications during the study trial\n\nExclusion Criteria:\n\n* presence of medical conditions that would be unsafe to exercise\n* diagnosed with other neurological conditions (e.g. Parkinson's disease, Stroke, Multiple Sclerosis, AD) that affect cognition and mobility\n* presence of depressive symptoms\n* presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis, Asthma, Hypertension, Diabetes mellitus, Coronary artery disease)\n* exercise regularly (at least 30 min/day, 3 days/week)"}, 'identificationModule': {'nctId': 'NCT03805620', 'briefTitle': 'Effects of Combined Physical-cognitive Training on Cognitive Function in MCI', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Synergistic Effects of Combined Physical-cognitive Training on Cognitive Function in Individuals With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AMS-CMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phys Group', 'description': 'physical training group', 'interventionNames': ['Other: Physical training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cog Group', 'description': 'cognitive training group', 'interventionNames': ['Other: Cognitive training']}, {'type': 'EXPERIMENTAL', 'label': 'Phys-Cog Group', 'description': 'combined physical-cognitive training group', 'interventionNames': ['Other: Combined physical-cognitive training']}, {'type': 'NO_INTERVENTION', 'label': 'Con Group', 'description': 'educational control group'}], 'interventions': [{'name': 'Combined physical-cognitive training', 'type': 'OTHER', 'description': 'combined physical-cognitive training', 'armGroupLabels': ['Phys-Cog Group']}, {'name': 'Physical training', 'type': 'OTHER', 'description': 'Multi-component physical exercise', 'armGroupLabels': ['Phys Group']}, {'name': 'Cognitive training', 'type': 'OTHER', 'description': 'cognitive training', 'armGroupLabels': ['Cog Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Faculty of Associated Medical Sciences, Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Somporn Sungkarat, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Somporn Sungkarat', 'investigatorAffiliation': 'Chiang Mai University'}}}}