Mild Cognitive Impairment Clinical Trial
— CALLI-MCIOfficial title:
Can Chinese Calligraphy Writing Enhance Cognitive Performance and Emotional Calmness in Older Adults With Mild Cognitive Impairment? A RCT Study
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | April 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Meeting Petersen's criteria for mild cognitive impairment - Being able to read simple Chinese characters - Community-dwelling - Clinical Dementia Rating score of 0.5 - No substantial prior experience of calligraphy writing - Willing to write using a brush and willing to participate Exclusion Criteria: - Presence of musculoskeletal problems preventing participants from writing - Known chronic cardiovascular (e.g. systolic BP > 140mmHg) or pulmonary conditions requiring long-term medication - Presence of severe mental disorder such as psychosis or depression. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Hong Kong Polytechnic University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
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. — View Citation
Belleville S, Gilbert B, Fontaine F, Gagnon L, Ménard 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. Epub 2006 Oct 16. — View 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. — View 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. — View 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. Review. — View 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. Epub 2007 Jun 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Digit span backward test (DSB) from baseline, after end of training, and 6-month follow-up. | DSB evaluates working memory, which requires recalling digits in reverse order. The DSB test is structured with increased levels of difficulty. | Baseline, within 2 weeks after end of training, and 6-month follow-up. | No |
Secondary | Color Trails Test (CTT) | 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. | Baseline, within 2 weeks after end of training, and 6-month follow-up. | No |
Secondary | Symbol-digit Modalities Test (SDMT) | 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. | Baseline, within 2 weeks after end of training, and 6-month follow-up. | No |
Secondary | Heart rate and heart rate variability. | It is measured by the Polar RS800C. | At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention. | No |
Secondary | Blood pressure. | It is measured by the Portapres. | At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention. | No |
Secondary | Geriatric Depression Scale - Short Form (GDS-SF) | 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). | Baseline, within 2 weeks after end of training, and 6-month post-intervention. | No |
Secondary | Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB) | CERAD-NAB is used to ask subjects to recall or identify the list of words learnt after a five minute delay. | Baseline, within 2 weeks after end of training, and 6-month post-intervention. | No |
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