Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People (CALLI-MCI)
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Calligraphy Training
iPad Training
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Cognitive training, Calligraphy, Emotional calmness, Working memory
Eligibility Criteria
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.
Sites / Locations
- The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Calligraphy Training
iPad Training
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Heart rate and heart rate variability.
It is measured by the Polar RS800C.
Blood pressure.
It is measured by the Portapres.
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).
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.
Full Information
NCT ID
NCT02755792
First Posted
April 22, 2016
Last Updated
April 26, 2016
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT02755792
Brief Title
Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People
Acronym
CALLI-MCI
Official Title
Can Chinese Calligraphy Writing Enhance Cognitive Performance and Emotional Calmness in Older Adults With Mild Cognitive Impairment? A RCT Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Cognitive training, Calligraphy, Emotional calmness, Working memory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calligraphy Training
Arm Type
Experimental
Arm 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.
Arm Title
iPad Training
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Calligraphy Training
Intervention Type
Behavioral
Intervention Name(s)
iPad Training
Primary Outcome Measure Information:
Title
Change in Digit span backward test (DSB) from baseline, 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.
Time Frame
Baseline, within 2 weeks after end of training, and 6-month follow-up.
Secondary Outcome Measure Information:
Title
Color Trails Test (CTT)
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.
Time Frame
Baseline, within 2 weeks after end of training, and 6-month follow-up.
Title
Symbol-digit Modalities Test (SDMT)
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.
Time Frame
Baseline, within 2 weeks after end of training, and 6-month follow-up.
Title
Heart rate and heart rate variability.
Description
It is measured by the Polar RS800C.
Time Frame
At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.
Title
Blood pressure.
Description
It is measured by the Portapres.
Time Frame
At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.
Title
Geriatric Depression Scale - Short Form (GDS-SF)
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).
Time Frame
Baseline, within 2 weeks after end of training, and 6-month post-intervention.
Title
Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)
Description
CERAD-NAB is used to ask subjects to recall or identify the list of words learnt after a five minute delay.
Time Frame
Baseline, within 2 weeks after end of training, and 6-month post-intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chetwyn CH Chan, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
16631882
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.
Results Reference
background
PubMed Identifier
17605579
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.
Results Reference
background
PubMed Identifier
12611751
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.
Results Reference
background
PubMed Identifier
20808089
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.
Results Reference
background
PubMed Identifier
17596582
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.
Results Reference
background
PubMed Identifier
17050952
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.
Results Reference
background
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Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People
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