Mild Cognitive Impairment (MCI), Moderate Cognitive Impairment, Oral Frailty
Conditions
Keywords
Oral function, Cognition, Dual task training, Elderly
Brief summary
The goal of this clinical trial is to proposes a novel Oral Motor and Cognitive Dual-Task Training (OMCDT) program that combines both oral motor exercises and cognitive tasks to improve brain and oral function at the same time. It will also learn about the safety of drug ABC. The main questions it aims to answer is: Does the OMCDT training can improve the oral and cognitive functions? Participants will: Take the OMCDT training once a week for 32 weeks Visit the lab twice in the intervention period (16-week, 32-week) for checkups and tests
Interventions
OTHEROral Motor and Cognitive Dual-Task Training (OMCDT)
Oral Motor and Cognitive Dual-Task Training (OMCDT) program that combines both oral motor exercises and cognitive tasks to improve brain and oral function at the same time, where the training includes 4 types of combined oral and cognitive functions.
BEHAVIORALOral motor exercise
The intervention will include four components: tongue-lip coordination exercises, tongue muscle strengthening exercises, lip and cheek muscle strengthening exercises, and mastication exercises. Each component will be repeated for seven rounds, with a 10-second rest interval between rounds. The intervention will be delivered once per week.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
After getting the consent of the participants, participants will be randomly assigned to two different groups using computer-generated numbers. The allocation will be carried out by using the closed-envelope method. The research assistant involved in assessing the outcome will be blinded to the allocation. The allocation will be released after completing the baseline data collection.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 50 years or above; 2. Cantonese speaking; 3. Having oral frailty, which is defined as having at least two of the following components by Oral Frailty Five-item Checklist (OF-5): (i) Natural teeth fewer than 20, (ii) Have any difficulties eating tough foods now compared with 6 months ago; (iii) Have choked on tea or soup recently; (iv) Often experience having a dry mouth, and (v) Oral diadochokinetic /ta/ sound \<6.0 times/second; 4. Having subjective cognitive decline (SCD), which refers to self-reported experience of worsening or more frequent confusion or memory loss in the past 12 month, or having been diagnosed with mild or moderate cognitive impairment; defined as a score of 0.5, 1, or 2 on Clinical Dementia Rating (C.D.R) scale; 5. Living independently or with partial assistance, defined as a score of Modified Barthel Index score greater than 60 out of 100; 6. Right-handed person to minimize variability in cortical activation patterns during fNIRS measurement; 7. Can understand the purpose and contents of this project and could give written consent.
Exclusion criteria
1. Have attended the dental clinics for dental treatment or received orofacial myofunctional therapy (OMT), involving doing certain oral exercises with cheeks, tongue, or lips in previous 6 months; 2. Have received other cognitive training in previous 6 month; 3. Have impaired vision or hearing capacity that cannot understand the training instructions; 4. Have a diagnosis of a neurological or psychiatric condition that could affect cognitive function; 5. Have terminal illness, Temporomandibular joint dysfunction (TMJ) disorders; Sjogren's (SHOW-grins) syndrome; 6. Have undergone glossectomy surgery; 7. have been taking drugs that affect cognitive function (e.g. Benzodiazepines, antidepressants, central nervous drugs).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participant randomized divided by proportion of people eligible | Week 16; Week-32 | Recruitment rate will be assessed by calculating the proportion of participant randomized divided by proportion of people eligible. |
| Number of participants that withdraw divided by number of participants randomized | 16-week; 32-week | Attrition rate will be assessed by calculating the number of participants that withdraw divided by number of participants randomized |
| Proportion of participants who complete the allocated intervention with a minimum of 80% attendance | 16-week; 32-week | Intervention completion rate will be assessed by calculating the proportion of participants who complete the allocated intervention with a minimum of 80% attendance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tongue pressure | Baseline, 16-week, 32-week | The tongue pressure will be measured three times using a tongue pressure meter (JMS Co., Ltd., Hiroshima, Japan) and the maximum value will be recorded. |
| Oral motor coordination | baseline; 16-week; 32-week | Cantonese-specific ODK test will be assessed by counting the number of monosyllabic, disyllabic, and trisyllabic Cantonese syllables (e.g., /bo1/, /bui1 dip6/, /bei2 daan6 gou1/) that the subject can speak out correctly over 5-second interval. |
| Masticatory ability | baseline; 16-week; 32-week | Masticatory ability will be evaluated using xylitol chewing check gum (Lotte, Tokyo, Japan). Participants will be instructed to chew the xylitol chewing check gum for 60 seconds. After chewing, place the gum on white paper and compare against a standardized color scale. |
| Self-reported oral health | Baseline, 16-week, 32-week | The self-reported oral health will be evaluated by General Oral Health Assessment Index (GOHAI). the Chinese version of GOHAI include 12 items There are five response categories for each question (l=always, 2=often,3=sometimes,4=seldom,and 5=never). The GOHAI score was computed by adding up the scores of the responses to the 12 questions and a higher score indicates a better reported oral health status. |
| Global cognitive status | Baseline, 16-week, 32-week | The total score of Hong Kong Version of Montreal Cognitive Assessment (HK-MoCA) |
| Executive function | baseline; 16-week; 32-week | The time in second used by completing the Trail Making Test Part A (TMT-A) and Part B (TMT-B) |
| Memory | baseline; 16-week; 32-week | The score of Fuld Object Memory Evaluation and Modified Verbal Fluency Test (F.O.M.E. \& M.V.F.T.). |
Countries
Hong Kong
Outcome results
None listed