Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-07 @ 3:37 PM
Study NCT ID:
NCT05172661
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2021-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Physical-Cognitive Training With Different Task Models in Parkinson's Disease With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-12-12', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline dual-task walking performance at 8 weeks', 'timeFrame': '8 weeks'}, {'measure': 'Fall frequency', 'timeFrame': '20 weeks'}, {'measure': 'Change from baseline Montreal Cognitive Assessment (MoCA) score at 8 weeks', 'timeFrame': '8 weeks', 'description': 'MoCA: 0-30 points, higher scores mean a better outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dual-task walking training', "Parkinson's disease", 'Mild cognitive impairment', 'Electroencephalography'], 'conditions': ['Mild Cognitive Impairment', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The present study will characterize exercise model effects (integrated model vs. consecutive model) of physical-cognitive exercise on dual-task walking control in Parkinson's disease with mild cognitive impairment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* a diagnosis of idiopathic Parkinson's disease\n* have decreased cognitive functions but do not interfere with functional independence\n* Montreal Cognitive Assessment (MoCA): 21-25\n* able to walk independently without walking devices for at least 10 meters and with the ability to turn 180°\n\nExclusion Criteria:\n\n* a diagnosis of dementia\n* other diseases that may influence cognitive functions or walking performance\n* a history of brain surgery\n* modification of the medication during the exercise intervention"}, 'identificationModule': {'nctId': 'NCT05172661', 'briefTitle': "Effects of Physical-Cognitive Training With Different Task Models in Parkinson's Disease With Mild Cognitive Impairment", 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': "Effects of Physical-Cognitive Training With Different Task Models on Dual-Task Walking in Parkinson's Disease With Mild Cognitive Impairment", 'orgStudyIdInfo': {'id': '202109095RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated training model', 'description': 'Participants in this group will accept postural and cognitive training at the same time, e.g. naming animals while standing on the foam.\n\nEach training session will last for 70 minutes, twice a week, and 12 sessions in total.', 'interventionNames': ['Behavioral: Integrated physical-cognitive training']}, {'type': 'EXPERIMENTAL', 'label': 'Consecutive training model', 'description': 'Participants in this group will accept postural and cognitive training separately and for identical durations (both 30 minutes).\n\nEach training session will last for 70 minutes, twice a week, and 12 sessions in total.', 'interventionNames': ['Behavioral: Consecutive physical-cognitive training']}], 'interventions': [{'name': 'Integrated physical-cognitive training', 'type': 'BEHAVIORAL', 'description': 'Perform a postural task and a cognitive task at the same time (dual-task model) 70 minutes/session\\*2 sessions/week\\*6 weeks', 'armGroupLabels': ['Integrated training model']}, {'name': 'Consecutive physical-cognitive training', 'type': 'BEHAVIORAL', 'description': 'Perform a postural task and a cognitive task separately for identical durations 70 minutes/session\\*2 sessions/week\\*6 weeks', 'armGroupLabels': ['Consecutive training model']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}