Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT04951258
Status:
UNKNOWN
Last Update Posted:
2021-08-24
First Post:
2021-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicomponent Exercise in People With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-21', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini-Mental State Examination', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Higher scores mean a better outcome.'}, {'measure': 'Chinese version of Verbal learning test', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a 9-point measurement to evaluate memory. Higher scores mean a better outcome.'}, {'measure': 'Chinese version of Stroop color and word test', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a measurement to evaluate inhibition control.'}, {'measure': 'Digit span test', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a measurement to evaluate working memory.'}, {'measure': 'Trail making test - Chinese version', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a measurement to evaluate cognitive flexibility.'}], 'secondaryOutcomes': [{'measure': 'Barthel index', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a 100-point ordinal scale used to measure performance in activities of daily living. Higher scores mean a better outcome.'}, {'measure': 'Instrumental activities of daily living (IADL) scale', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a 24-point ordinal scale used to measure performance in instrumental activities of daily living. Higher scores mean a better outcome.'}, {'measure': 'Chinese version of Quality of Life in Alzheimer Disease Scale', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a measurement to evaluate quality of life. The scale scores range from 13 to 52, with higher scores indicating greater quality of life.'}, {'measure': 'Time up and go test', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a test to evaluate functional mobility.'}, {'measure': '30-second chair stand test', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a test to evaluate muscle strength.'}, {'measure': '6-minute walk test', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a test to evaluate endurance.'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'Change from baseline at 9 week', 'description': 'It is a tool to evaluate balance. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': "People with dementia shows a decline in cognition, such as memory, executive function (EF), language, attention, and spatial orientation that is significant enough to interfere with the independence and daily functioning. Previous studies reported that multicomponent exercise improved EF in people with mild cognitive impairment and independence of ADL in those with Alzheimer's disease. However, few studies investigated whether multicomponent exercise improved EF, memory, and ADL in people with dementia. Therefore, the purposes of this study are to examine 1) the effect of multicomponent exercise on EF, memory, and ADL in people with mild to moderate dementia; 2) the correlation between change in EF and ADL; 3) the correlation between change in memory and ADL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 60-80 y/o\n* Mini-Mental State Examination: 10-26\n* Clinical Dementia Rating: 1-2\n* Walk at least 6 meters independently (with or without walking aids)\n\nExclusion Criteria:\n\n* Any other diagnosis of neurological diseases or musculoskeletal problems (Except dementia)\n* Physical or psychological comorbidities that affect performance during assessment or intervention\n* Already participating in other physical training in the last 1 month'}, 'identificationModule': {'nctId': 'NCT04951258', 'briefTitle': 'Multicomponent Exercise in People With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Effect of Multicomponent Exercise on Cognitive Function and Activities of Daily Living in People With Dementia', 'orgStudyIdInfo': {'id': 'YM110062F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multicomponent exercise group', 'interventionNames': ['Other: Multicomponent exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Video home exercise group', 'interventionNames': ['Other: Video home exercise group']}], 'interventions': [{'name': 'Multicomponent exercise', 'type': 'OTHER', 'description': 'The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Multicomponent exercise included strengthening, balance training, aerobic dance, and stretching', 'armGroupLabels': ['Multicomponent exercise group']}, {'name': 'Video home exercise group', 'type': 'OTHER', 'description': 'The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Video home exercise included four limbs mobility exercise, stretching, strengthening, and aerobic exercise', 'armGroupLabels': ['Video home exercise group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yea-Ru Yang, Professor', 'role': 'CONTACT', 'email': 'yryang@nycu.edu.tw', 'phone': '+886-2-28267279'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yea-Ru Yang', 'investigatorAffiliation': 'National Yang Ming Chiao Tung University'}}}}