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Completed

NCT Number: NCT02755792

Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calligraphy Training

Behavioral

iPad Training

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Can Chinese Calligraphy Writing Enhance Cognitive Performance and Emotional Calmness in Older Adults With Mild Cognitive Impairment? A RCT Study

Acronym: CALLI-MCI

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Apr 29, 2016
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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