NCT02755792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

3.4 years

First QC Date

April 22, 2016

Last Update Submit

April 26, 2016

Conditions

Keywords

Mild Cognitive ImpairmentCognitive trainingCalligraphyEmotional calmnessWorking memory

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

  • Color Trails Test (CTT)

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

  • Symbol-digit Modalities Test (SDMT)

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

  • Heart rate and heart rate variability.

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

  • Blood pressure.

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

  • Geriatric Depression Scale - Short Form (GDS-SF)

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

  • +1 more secondary outcomes

Study Arms (2)

Calligraphy Training

EXPERIMENTAL

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

iPad Training

ACTIVE COMPARATOR

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

Interventions

Calligraphy Training
iPad TrainingBEHAVIORAL
iPad Training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (6)

  • 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.

    PMID: 16631882BACKGROUND
  • 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.

    PMID: 17605579BACKGROUND
  • 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.

    PMID: 12611751BACKGROUND
  • 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.

    PMID: 20808089BACKGROUND
  • 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.

    PMID: 17596582BACKGROUND
  • 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.

    PMID: 17050952BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Chetwyn CH Chan, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Vice President (Learning and Teaching) and Chair Professor

Study Record Dates

First Submitted

April 22, 2016

First Posted

April 29, 2016

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations