Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People (CALLI-MCI)
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|ClinicalTrials.gov Identifier: NCT02755792|
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : April 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Behavioral: Calligraphy Training Behavioral: iPad Training||Not Applicable|
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.
Selected 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Can Chinese Calligraphy Writing Enhance Cognitive Performance and Emotional Calmness in Older Adults With Mild Cognitive Impairment? A RCT Study|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||April 2016|
Experimental: Calligraphy Training
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.
Behavioral: Calligraphy Training
Active Comparator: iPad Training
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.
Behavioral: iPad Training
- Change in Digit span backward test (DSB) from baseline, after end of training, and 6-month follow-up. [ Time Frame: Baseline, within 2 weeks 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.
- Color Trails Test (CTT) [ Time Frame: Baseline, within 2 weeks after end of training, and 6-month follow-up. ]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.
- Symbol-digit Modalities Test (SDMT) [ Time Frame: Baseline, within 2 weeks after end of training, and 6-month follow-up. ]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.
- Heart rate and heart rate variability. [ Time Frame: At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention. ]It is measured by the Polar RS800C.
- Blood pressure. [ Time Frame: At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention. ]It is measured by the Portapres.
- Geriatric Depression Scale - Short Form (GDS-SF) [ Time Frame: Baseline, within 2 weeks after end of training, and 6-month post-intervention. ]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).
- Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB) [ Time Frame: Baseline, within 2 weeks after end of training, and 6-month post-intervention. ]CERAD-NAB is used to ask subjects to recall or identify the list of words learnt after a five minute delay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755792
|The Hong Kong Polytechnic University|
|Hong Kong, Hong Kong|
|Principal Investigator:||Chetwyn CH Chan, PhD||The Hong Kong Polytechnic University|