Clinical trial NCT02755792: Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People
Official title: Can Chinese Calligraphy Writing Enhance Cognitive Performance and Emotional Calmness in Older Adults With Mild Cognitive Impairment? A RCT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Cognitive training
Calligraphy
Emotional calmness
Working memory
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 99
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Digit span backward test (DSB) from baseline, after end of training, and 6-month follow-up.
timeFrame: Baseline, within 2 weeks after end of training, and 6-month follow-up.
Secondary outcomes:
measure: Color Trails Test (CTT)
timeFrame: Baseline, within 2 weeks after end of training, and 6-month follow-up.
measure: Symbol-digit Modalities Test (SDMT)
timeFrame: Baseline, within 2 weeks after end of training, and 6-month follow-up.
measure: Heart rate and heart rate variability.
timeFrame: At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.
measure: Blood pressure.
timeFrame: At the week 1, 5, 9, 12 during the intervention period, and at 6-month post-intervention.
measure: Geriatric Depression Scale - Short Form (GDS-SF)
timeFrame: Baseline, within 2 weeks after end of training, and 6-month post-intervention.
measure: Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)
timeFrame: Baseline, within 2 weeks after end of training, and 6-month post-intervention.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Chetwyn CH Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.