- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04492644
The Correlation Among Nutrition, Muscle Strength, Masticatory and Swallow Ability of Inpatient Elders (NMM)
July 29, 2020 updated by: Yin-Hwa Shih, China Medical University Hospital
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.
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taichung, Taiwan, 404
- Asia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We enrolled 120 elderly inpatients in Asia University Hospital, Taiwan.
We included new elderly inpatients aged 65 years or older who were able to communicate and were clearly conscious.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
elderly inpatients
Elderly inpatients aged 65 years or older who were able to communicate and were clearly conscious.
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.
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
masticatory muscle surface EMG
Time Frame: Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
|
The sEMG examinations were conducted with a Zebris EMG Bluetooth muscle activity recording system
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Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional status
Time Frame: Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
|
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.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Handgrip force
Time Frame: Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
|
Left and right handgrip forces were measured by a Jamar® Hydraulic Hand Dynamometer
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Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yin-Hwa Shih, Ph.D., Asia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. doi: 10.1590/s1678-77572008000200007.
- 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 Review and Meta-analysis. JAMA Netw Open. 2019 Nov 1;2(11):e1915138. doi: 10.1001/jamanetworkopen.2019.15138.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2019
Primary Completion (Actual)
October 3, 2019
Study Completion (Actual)
October 3, 2019
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
July 29, 2020
First Posted (Actual)
July 30, 2020
Study Record Updates
Last Update Posted (Actual)
July 30, 2020
Last Update Submitted That Met QC Criteria
July 29, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH108-REC3-110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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