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

April 26, 2016 updated by: Prof. Chetwyn Chan, The Hong Kong Polytechnic University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, within 2 weeks after end of training, and 6-month follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, within 2 weeks after end of training, and 6-month follow-up.
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.
Baseline, within 2 weeks after end of training, and 6-month follow-up.
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.
At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.
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.
At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.
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).
Baseline, within 2 weeks after end of training, and 6-month post-intervention.
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.
Baseline, within 2 weeks after end of training, and 6-month post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Chetwyn CH Chan, PhD, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (ESTIMATE)

April 29, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Calligraphy-MCI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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