AzTrials
AzTrials

Mild Cognitive ImpairmentCALLI-MCINCT02755792

Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People

A study testing Calligraphy Training and iPad Training in people with Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Calligraphy Training and iPad Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteHong Kong
Study dates
Jul 2012to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The Hong Kong Polytechnic University

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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.

Being tested
Calligraphy Training, iPad Training
Keywords
Mild Cognitive Impairment, Cognitive training, Calligraphy, Emotional calmness, Working memory
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calligraphy TrainingBehavioural

  • iPad TrainingBehavioural

Study groups in NCT02755792
Study groupRoleWhat they receive
Calligraphy TrainingExperimentalThis 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.
Receives: Behavioral: Calligraphy Training
iPad TrainingActive comparatorThis 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.
Receives: Behavioral: iPad Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, within 2 weeks after end of training, and 6-month follow-up.

Secondary outcomes (6)

  1. 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.

    Measured: Baseline, within 2 weeks after end of training, and 6-month follow-up.

  2. 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.

    Measured: Baseline, within 2 weeks after end of training, and 6-month follow-up.

  3. Heart rate and heart rate variability.

    It is measured by the Polar RS800C.

    Measured: At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.

  4. Blood pressure.

    It is measured by the Portapres.

    Measured: At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.

  5. 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).

    Measured: Baseline, within 2 weeks after end of training, and 6-month post-intervention.

  6. 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.

    Measured: Baseline, within 2 weeks after end of training, and 6-month post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2016 (estimated)
  2. Study startJul 2012
  3. Primary completionDec 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02755792
Sponsor's protocol ID
Calligraphy-MCI
Acronym
CALLI-MCI
Status last verified
Apr 2016
First submitted
22 Apr 2016
Last updated
29 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16631882

  • 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.

    PubMed 17605579

  • 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.

    PubMed 12611751

  • 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.

    PubMed 20808089

  • 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.

    PubMed 17596582

  • 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.

    PubMed 17050952

Questions about this trial

What is this clinical trial studying?

A study testing Calligraphy Training and iPad Training in people with Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02755792, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in