Malnutrition; ModerateNMMNCT04492644
The Correlation Among Nutrition, Muscle Strength, Masticatory and Swallow Ability of Inpatient Elders
An observational study of Malnutrition; Moderate, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition; Moderate
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Aug 2019to 3 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- new elderly inpatients aged 65 years or older who were able to communicate and were clearly conscious
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Malnutrition; Moderate
- Being tested
- No intervention
- Keywords
- the elder inpatient,, nutritional assessment, handgrip strength, masticatory electromyography
- Medical subject headings
- Malnutrition, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
masticatory muscle surface EMG
The sEMG examinations were conducted with a Zebris EMG Bluetooth muscle activity recording system
Measured: Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
Secondary outcomes (1)
Nutritional status
Nutritional status was measured by the Mini Nutritional Assessment (MNA).
Measured: Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start28 Aug 2019
- Primary completion3 Oct 2019
- Study completion3 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malnutrition; ModerateStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, China
- Responsible party
- Principal investigator, Yin-Hwa Shih, China Medical University Hospital
- Investigators
- Yin-Hwa Shih, Ph.D., Principal investigator, Asia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492644
- Sponsor's protocol ID
- CMUH108-REC3-110
- Acronym
- NMM
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28673255Berretin-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.
PubMed 19089202Gomes 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.
PubMed 31747030
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Among Nutrition, Muscle Strength, Masticatory and Swallow Ability of Inpatient Elders
- ClinicalTrials.gov ID
- NCT04492644
- Acronym / sponsor ID
- NMM / CMUH108-REC3-110
- Conditions
- Malnutrition; Moderate
- Keywords
- the elder inpatient,, nutritional assessment, handgrip strength, masticatory electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- China Medical University, China
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly inpatients | – | Other: No interventionElderly 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- new elderly inpatients aged 65 years or older who were able to communicate and were clearly conscious
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | elderly inpatients |
Primary outcome
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
1 secondary outcome
Nutritional status
Time frame: Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Results publication: PubMed 28673255Alzahrani 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.
- Results publication: PubMed 19089202Berretin-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.
- Results publication: PubMed 31747030Gomes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin-Hwa Shih, Ph.D. principal investigator
Asia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition; Moderate, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
masticatory muscle surface EMG (time frame: Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492644, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.