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Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People (CALLI-MCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02755792
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Chetwyn Chan, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Calligraphy Training Behavioral: iPad Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Hong Kong
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Chetwyn CH Chan, PhD The Hong Kong Polytechnic University
Publications:

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Responsible Party: Prof. Chetwyn Chan, Associate Vice President (Learning and Teaching) and Chair Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02755792    
Other Study ID Numbers: Calligraphy-MCI
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Keywords provided by Prof. Chetwyn Chan, The Hong Kong Polytechnic University:
Mild Cognitive Impairment
Cognitive training
Calligraphy
Emotional calmness
Working memory
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders