Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-27 @ 6:09 AM
Study NCT ID:
NCT05629650
Status:
COMPLETED
Last Update Posted:
2022-12-01
First Post:
2022-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Tai Chi for Cognitively Impaired Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026302', 'term': 'Tai Ji'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'two intervention groups (1) those with MCI (2) those with dementia'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-29', 'studyFirstSubmitDate': '2022-11-12', 'studyFirstSubmitQcDate': '2022-11-17', 'lastUpdatePostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physical function-grip strength', 'timeFrame': 'changes from pretest to 12 week posttest scores', 'description': 'grip strength by assessed in both hands using a digital hand dynamometer (0-90 kg; Labisen KS-301)'}, {'measure': 'physical function - flexibility', 'timeFrame': 'changes from pretest to 12 week posttest scores', 'description': 'by the standard sit-and-reach test (SSRT)'}, {'measure': 'physical function - balance', 'timeFrame': 'changes from pretest to 12 week posttest scores', 'description': 'assessed using a one-leg-standing balance test (OLST)'}, {'measure': 'physical function - mobility', 'timeFrame': 'changes from pretest to 12 week posttest scores', 'description': 'assessed by the Timed Up and Go test (TUG)'}], 'secondaryOutcomes': [{'measure': 'emotional functioning - depression', 'timeFrame': 'changes from pretest to 12 week posttest scores', 'description': 'assessed by the short form of the Korean version of the Geriatric Depression Scale (SGDS-K) with 16 items (yes/no). higher scores indicate more depressive symptoms'}, {'measure': 'Short Form Health Survey 12 (SF12)', 'timeFrame': 'changes from pretest to 12 week posttest scores', 'description': 'Short Form Health Survey 12, which consists of eight dimensions: general health, physical functioning, role physical, body pain, vitality, social functioning, role emotional, and mental health. two summary scores for the physical and mental components of health-related QoL are calculated by using the weighted means for the eight domains.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tai Chi', 'cognitive impairment', 'dementia'], 'conditions': ['Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '36869290', 'type': 'DERIVED', 'citation': 'Oh H, Song R, Kim SJ. Effects of 12-week Tai Chi program on physical function, depression, and quality of life among cognitively impaired older adults: a feasibility study. BMC Geriatr. 2023 Mar 3;23(1):118. doi: 10.1186/s12877-023-03840-2.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the feasibility of a 12-week program of Tai Chi for memory (TCM) among older adults with mild cognitive impairment (MCI) or dementia and to determine the effects of TCM on physical functioning, depression, and health-related QoL. Two experimental groups will be recruited for inclusion criteria of community-residing older adults with a diagnosis of either MCI or Dementia.', 'detailedDescription': 'The purpose of the study are to determine the acceptability of a 12-week program of Tai Chi for memory (TCM) among older adults with mild cognitive impairment (MCI) or dementia; and to determine the effects of TCM on physical functioning, depression, and health-related QoL.\n\nA quasi-experimental design was used with two groups classified according to the level of their cognitive impairment (MCI vs. Dementia).\n\nDepression, health-related QoL, and physical functioning including grip strength, balance, flexibility, and mobility were measured before and after the 12-week TCM program.\n\nDepression was measured using the Korean version of the Geriatric Depression Scale.\n\nHealth-related QoL was measured using the 12-item Short Form survey (SF-12). Grip strength was assessed using a digital hand dynamometer. Flexibility was assessed using the standard sit-and-reach test. Balance was measured using the one-leg-standing balance test. Mobility was assessed using the timed up and go test. Paired and independent t-tests will be used to compare the effects of TCM within and between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* community-residing older adults aged 75 years or older,\n* registered at the public dementia prevention centers for dementia screening by health professionals with the diagnosis of either MCI or dementia,\n* Korean version of the Montreal Cognitive Assessment (MoCA-K) score of 22 or lower,\n* agreed to participate in the Tai Chi program twice a week for 12 weeks.\n\nExclusion Criteria:\n\n* participated in any formal regular exercise program during the previous 6 months, and'}, 'identificationModule': {'nctId': 'NCT05629650', 'acronym': 'TCM', 'briefTitle': 'Feasibility Study of Tai Chi for Cognitively Impaired Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Chungnam National University'}, 'officialTitle': 'Effects of 12-week Tai Chi Program on Physical Function, Depression, and Quality of Life Among Cognitively Impaired Older Adults: A Feasibility Study', 'orgStudyIdInfo': {'id': 'ChungnamNU3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tai Chi for memory', 'description': 'TCM is a standardized type of Tai Chi for health developed by Dr. Lam specifically for those who experience or want to prevent cognitive problems. TCM, consisting of 12 Sun-style and Yang-style Tai Chi movements, can be provided while sitting and while standing with five blocked movement sets so that cognitively impaired individuals (MCI vs. dementia) are able to follow them.', 'interventionNames': ['Behavioral: Tai Chi for memory']}], 'interventions': [{'name': 'Tai Chi for memory', 'type': 'BEHAVIORAL', 'description': 'The adapted form of TCM will be provided at 60 minutes per session, twice a week for 12 weeks by a certified Tai Chi instructor who had experience in teaching older adults with cognitive impairments.', 'armGroupLabels': ['Tai Chi for memory']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35010', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Tai Chi for health institute', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}], 'overallOfficials': [{'name': 'Rhayun Song, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungnam National University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'January-December, 2024', 'ipdSharing': 'YES', 'description': 'upon request, study protocol and the data without individual IDs can be shared with other researchers.', 'accessCriteria': 'researchers or reviewers who requested for clinical study or meta-analysis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chungnam National University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation, Singapore', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rhayun Song', 'investigatorAffiliation': 'Chungnam National University'}}}}