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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04492644
Other study ID # CMUH108-REC3-110
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 28, 2019
Est. completion date October 3, 2019

Study information

Verified date July 2020
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The masticatory performance would affect the nutritional status of elderly people. the prevalence of undernutrition among elderly inpatients is %20-50%. Previous related studies investigate the masticatory performance with special chewing gum and self-reported questionnaires. This study observes the correlation of masticatory muscles sEMG, nutritional status, and handgrip force among elderly inpatients.


Description:

In this cross-sectional study, we enrolled 120 seniors aged 65 and above who are newly admitted to the Asian University Hospital. Within 24 hours they admitted to the hospital, we collected the Mini Nutritional Assessment scores, surface electromyography data, handgrip strength, self-assessment swallowing ability score, and clinical objective data. We performed the statistics for independent t-test, Pearson correlation analysis, and binary logistic regression with SPSS 23 software.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 3, 2019
Est. primary completion date October 3, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- new elderly inpatients aged 65 years or older who were able to communicate and were clearly conscious

Exclusion Criteria:

- Elderly individuals who were diagnosed with gastrointestinal (GI) dysfunction, dysphagia, edentulism without rehabilitation with dentures, brain disease, stroke or cancer were excluded due to the possibility of dysphagia, cachexia or masticatory muscle palsy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
Taiwan Asia University Taichung

Sponsors (2)

Lead Sponsor Collaborator
China Medical University Hospital China Medical University, China

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Alzahrani SH, Alamri SH. Prevalence of malnutrition and associated factors among hospitalized elderly patients in King Abdulaziz University Hospital, Jeddah, Saudi Arabia. BMC Geriatr. 2017 Jul 3;17(1):136. doi: 10.1186/s12877-017-0527-z. — View Citation

Berretin-Felix G, Nary Filho H, Padovani CR, Trindade Junior AS, Machado WM. Electromyographic evaluation of mastication and swallowing in elderly individuals with mandibular fixed implant-supported prostheses. J Appl Oral Sci. 2008 Mar-Apr;16(2):116-21. — View Citation

Gomes F, Baumgartner A, Bounoure L, Bally M, Deutz NE, Greenwald JL, Stanga Z, Mueller B, Schuetz P. Association of Nutritional Support With Clinical Outcomes Among Medical Inpatients Who Are Malnourished or at Nutritional Risk: An Updated Systematic Revi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Handgrip force Left and right handgrip forces were measured by a JamarĀ® Hydraulic Hand Dynamometer Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
Primary masticatory muscle surface EMG The sEMG examinations were conducted with a Zebris EMG Bluetooth muscle activity recording system Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
Secondary Nutritional status Nutritional status was measured by the Mini Nutritional Assessment (MNA). Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
See also
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