Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Calligraphy Training; Behavioral: iPad Training

• Registration Number: NCT02755792
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2015-12
• Status Verified: 2016-04
• Study Completion: 2016-04
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Study First Posted: 2016-04-29
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calligraphy Training	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.
iPad Training	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.

Primary Outcome Measures

Name	Time	Method
Change in Digit span backward test (DSB) from baseline, after end of training, and 6-month follow-up.	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

Name	Time	Method
Heart rate and heart rate variability.	At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.	It is measured by the Polar RS800C.
Color Trails Test (CTT)	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.
Blood pressure.	At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.	It is measured by the Portapres.
Symbol-digit Modalities Test (SDMT)	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.
Geriatric Depression Scale - Short Form (GDS-SF)	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)	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.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong