NCT04492644

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

July 28, 2020

Last Update Submit

July 29, 2020

Conditions

Malnutrition; Moderate

Keywords

the elder inpatient,nutritional assessmenthandgrip strengthmasticatory electromyography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Nutritional status

    Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.

Other Outcomes (1)

  • Handgrip force

    Data were collected after the participants signed the informed consent form within 24 hours admitted to hospital.

Study Arms (1)

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.

Other: No intervention

Interventions

No interventionOTHER

No intervention

elderly inpatients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia University

Taichung, 404, Taiwan

Location

Related 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.

    PMID: 28673255RESULT

  • 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.

    PMID: 19089202RESULT

  • 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.

    PMID: 31747030RESULT

MeSH Terms

Conditions

MalnutritionLymphoma, Follicular

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Yin-Hwa Shih, Ph.D.

    Asia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 30, 2020

Study Start

August 28, 2019

Primary Completion

October 3, 2019

Study Completion

October 3, 2019

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)