Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT04436302
Status:
UNKNOWN
Last Update Posted:
2020-06-18
First Post:
2020-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exergaming in People With Major Neurocognitive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-15', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MoCA', 'timeFrame': '2 years', 'description': 'Montréal Cognitive Assessment'}, {'measure': 'SPPB', 'timeFrame': '2 years', 'description': 'Short Physical Performance Battery'}, {'measure': 'NPI', 'timeFrame': '2 years', 'description': 'Neuropsychiatric Inventory'}, {'measure': 'CSDD', 'timeFrame': '2 years', 'description': 'Cornell Scale for Depression in Dementia'}, {'measure': 'DQOL', 'timeFrame': '2 years', 'description': 'Dementia Quality of Life'}, {'measure': '(I)ADL', 'timeFrame': '2 years', 'description': 'Activities of daily living'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Randomised Controlled Trial', 'Major Neurocognitive Disorder', 'Long-term Care Facility', 'Physical Activity', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '33785077', 'type': 'DERIVED', 'citation': 'Swinnen N, Vandenbulcke M, de Bruin ED, Akkerman R, Stubbs B, Firth J, Vancampfort D. The efficacy of exergaming in people with major neurocognitive disorder residing in long-term care facilities: a pilot randomized controlled trial. Alzheimers Res Ther. 2021 Mar 30;13(1):70. doi: 10.1186/s13195-021-00806-7.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (MNCD) residing in long-term care facilities.', 'detailedDescription': 'This randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (MNCD) residing in long-term care facilities. Fifty inpatients with mild to moderate MNCD will be randomly assigned to three times weekly for eight weeks 15 min of exergaming versus watching preferred music videos. The Montréal Cognitive Assessment (MoCA), Short Physical Performance Battery (SPPB), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Dementia Quality of Life (DQoL), Katz activities of daily living (ADL) and Instrumental ADL (IADL) are measured at baseline and post intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria included:\n\n* a Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 diagnosis of MNCD (American Psychiatric Association, 2013)\n* aged 65 years or older\n* a score of minimum 10 on the Mini-Mental State Examination (MMSE)\n* residing at least two weeks in the care facility at the time of inclusion\n* being physically capable of doing standing exercises (whether or not with extra support).\n\nPossible causes of MNCD were vascular dementia, Alzheimer's disease, mixed dementia, Parkinson's disease or Lewy body disease.\n\nExclusion criteria consisted of:\n\n* any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation\n* a score lower than 10 on the MMSE\n* a planned transfer to another setting within the following two months."}, 'identificationModule': {'nctId': 'NCT04436302', 'briefTitle': 'Exergaming in People With Major Neurocognitive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'The Efficacy of Exergaming in People With Major Neurocognitive Disorder Residing in Long-term Care Facilities: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '042020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Dividat senso exergame device', 'interventionNames': ['Device: Exergame device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Listening to music', 'interventionNames': ['Device: Exergame device']}], 'interventions': [{'name': 'Exergame device', 'type': 'DEVICE', 'otherNames': ['Dividat senso'], 'description': 'motor-cognitive training', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Riekje Akkerman', 'role': 'CONTACT'}], 'facility': "Long-term care facility 'de Wingerd'", 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Nathalie Swinnen', 'role': 'CONTACT', 'email': 'nathalie.swinnen@kuleuven.be', 'phone': '0032484657187'}, {'name': 'Davy Vancampfort', 'role': 'CONTACT', 'email': 'davy.vancampfort@kuleuven.be', 'phone': '+32 16 37 65 64'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Davy Vancampfort', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Davy Vancampfort', 'investigatorAffiliation': 'KU Leuven'}}}}