Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-03-27 @ 8:48 AM
Study NCT ID:
NCT02755792
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2016-04-22', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Digit span backward test (DSB) from baseline, after end of training, and 6-month follow-up.', 'timeFrame': 'Baseline, within 2 weeks after end of training, and 6-month follow-up.', 'description': 'DSB evaluates working memory, which requires recalling digits in reverse order. The DSB test is structured with increased levels of difficulty.'}], 'secondaryOutcomes': [{'measure': 'Color Trails Test (CTT)', 'timeFrame': 'Baseline, within 2 weeks after end of training, and 6-month follow-up.', 'description': 'CTT is consisted of two parts. CTT 1 evaluates attention and perceptual speed. Participants are asked to draw a line to between circles in consecutive order numbered 1 - 25, as quickly as possible. CTT 2 evaluates set-shifting. Each number (1 - 25) of CTT 2 is printed twice, one in pink and another in yellow color circle. Subjects are asked to connect the numbers in consecutive order but alternating between pink and yellow.'}, {'measure': 'Symbol-digit Modalities Test (SDMT)', 'timeFrame': 'Baseline, within 2 weeks after end of training, and 6-month follow-up.', 'description': 'SDMT evaluates executive function, in particular mental flexibility, of older people with cognitive impairment. It is a simple substitution task in which participants are asked to substitute series of symbols with specific digits within a period of 90 seconds.'}, {'measure': 'Heart rate and heart rate variability.', 'timeFrame': 'At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.', 'description': 'It is measured by the Polar RS800C.'}, {'measure': 'Blood pressure.', 'timeFrame': 'At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.', 'description': 'It is measured by the Portapres.'}, {'measure': 'Geriatric Depression Scale - Short Form (GDS-SF)', 'timeFrame': 'Baseline, within 2 weeks after end of training, and 6-month post-intervention.', 'description': 'GDS-SF measures subjective appraisal of the mood state. It consists of 15 statements about various aspects of mood such as appetite, quality of sleep, hope, and social functioning. Each statement is responded using a dichotomous format (yes/no).'}, {'measure': "Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)", 'timeFrame': 'Baseline, within 2 weeks after end of training, and 6-month post-intervention.', 'description': 'CERAD-NAB is used to ask subjects to recall or identify the list of words learnt after a five minute delay.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment', 'Cognitive training', 'Calligraphy', 'Emotional calmness', 'Working memory'], 'conditions': ['Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '16631882', 'type': 'BACKGROUND', 'citation': 'Gauthier S, Reisberg B, Zaudig M, Petersen RC, Ritchie K, Broich K, Belleville S, Brodaty H, Bennett D, Chertkow H, Cummings JL, de Leon M, Feldman H, Ganguli M, Hampel H, Scheltens P, Tierney MC, Whitehouse P, Winblad B; International Psychogeriatric Association Expert Conference on mild cognitive impairment. Mild cognitive impairment. Lancet. 2006 Apr 15;367(9518):1262-70. doi: 10.1016/S0140-6736(06)68542-5.'}, {'pmid': '17605579', 'type': 'BACKGROUND', 'citation': "Belleville S, Chertkow H, Gauthier S. Working memory and control of attention in persons with Alzheimer's disease and mild cognitive impairment. Neuropsychology. 2007 Jul;21(4):458-69. doi: 10.1037/0894-4105.21.4.458."}, {'pmid': '12611751', 'type': 'BACKGROUND', 'citation': 'Boyle PA, Malloy PF, Salloway S, Cahn-Weiner DA, Cohen R, Cummings JL. Executive dysfunction and apathy predict functional impairment in Alzheimer disease. Am J Geriatr Psychiatry. 2003 Mar-Apr;11(2):214-21.'}, {'pmid': '20808089', 'type': 'BACKGROUND', 'citation': 'Chan WC, Lam LC, Tam CW, Lui VW, Chan SS, Chan WM, Chiu HF. Prevalence of neuropsychiatric symptoms in chinese older persons with mild cognitive impairment-a population-based study. Am J Geriatr Psychiatry. 2010 Oct;18(10):948-54. doi: 10.1097/JGP.0b013e3181d69467.'}, {'pmid': '17596582', 'type': 'BACKGROUND', 'citation': 'Wilson RS, Scherr PA, Schneider JA, Tang Y, Bennett DA. Relation of cognitive activity to risk of developing Alzheimer disease. Neurology. 2007 Nov 13;69(20):1911-20. doi: 10.1212/01.wnl.0000271087.67782.cb. Epub 2007 Jun 27.'}, {'pmid': '17050952', 'type': 'BACKGROUND', 'citation': 'Belleville S, Gilbert B, Fontaine F, Gagnon L, Menard E, Gauthier S. Improvement of episodic memory in persons with mild cognitive impairment and healthy older adults: evidence from a cognitive intervention program. Dement Geriatr Cogn Disord. 2006;22(5-6):486-99. doi: 10.1159/000096316. Epub 2006 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'This study is aimed to investigate the efficacy of an 12-week Chinese calligraphy training program for enhancing cognitive and emotional functions of older adults with mild cognitive impairment. Participants are tested with several cognitive tests and electroencephalography (EEG), psycho-physical parameters and brain activities are recorded. Results are compared at pre-intervention, post-intervention, and 6-month post-intervention to provide evidence of benefits of Chinese calligraphy practice.', 'detailedDescription': 'Participants are older adults with mild cognitive impairment, who will be recruited from several community elderly centers in Hong Kong according to selective criteria. The participants are randomly assigned to an experimental or a control group. The experimental group is invited to participate in 16 sessions of structured Chinese calligraphy program over 12 weeks. Each session lasts for 1.5 hours. The control group is invited to participate in an iPad learning program with navigating the Internet. The iPad program is also consisted of 16 sessions of 1.5 hours each over 8 weeks. Cognitive tests and physiological measures are conducted immediately before and after intervention and at 6-month post-intervention follow-up. Statistical analysis are performed to investigate the significant differences and interactions among the three time points. The association of cognitive performance and emotional calmness is also investigated.\n\nSelected participants are invited to take part in a EEG session while doing some computer tasks related to Chinese calligraphy. EEG results of are used to explore neural activities associated with visuospatial working memory and to provide evidence for neural changes at functional level as a result of Chinese calligraphy training and practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meeting Petersen's criteria for mild cognitive impairment\n* Being able to read simple Chinese characters\n* Community-dwelling\n* Clinical Dementia Rating score of 0.5\n* No substantial prior experience of calligraphy writing\n* Willing to write using a brush and willing to participate\n\nExclusion Criteria:\n\n* Presence of musculoskeletal problems preventing participants from writing\n* Known chronic cardiovascular (e.g. systolic BP \\> 140mmHg) or pulmonary conditions requiring long-term medication\n* Presence of severe mental disorder such as psychosis or depression."}, 'identificationModule': {'nctId': 'NCT02755792', 'acronym': 'CALLI-MCI', 'briefTitle': 'Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Can Chinese Calligraphy Writing Enhance Cognitive Performance and Emotional Calmness in Older Adults With Mild Cognitive Impairment? A RCT Study', 'orgStudyIdInfo': {'id': 'Calligraphy-MCI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calligraphy Training', 'description': 'This group receives a Chinese calligraphy training program of 16 sessions over 8 weeks in a class of 8-12 participants. Each session is 1.5 hours.', 'interventionNames': ['Behavioral: Calligraphy Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'iPad Training', 'description': 'This group receives an iPad training program of 16 sessions over 8 weeks in a class of 8-12 participants. Each session is 1.5 hours.', 'interventionNames': ['Behavioral: iPad Training']}], 'interventions': [{'name': 'Calligraphy Training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Calligraphy Training']}, {'name': 'iPad Training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['iPad Training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Chetwyn CH Chan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Vice President (Learning and Teaching) and Chair Professor', 'investigatorFullName': 'Prof. Chetwyn Chan', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}