An interventional study of Integrated Oral Function Intervention in Frailty at Older Adults, Mastication and Physical Functional Performance, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Health services research
Oral frailty is a potentially reversible condition associated with physical frailty and functional decline in older adults. Interventions targeting oral function may therefore improve broader physical health. This study aim to evaluate oral and physical functional changes after a 6-month integrated intervention and compare these changes over 12 months.
Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 288 studies on the registry; 57 are open to participants now.
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Behavioral: Integrated Oral Function Intervention
The six-month multidisciplinary intervention was tailored for implementation in Taiwanese community settings. Participants were subsequently followed for up to 12 months to evaluate the maintenance of the changes. The intervention was designed as an integrated oral and physical function-based approach to frailty prevention and comprised four core components: (1) health education, (2) integrated physical and oral exercises, (3) masticatory-enhancing textured meals, and (4) digital behavioral reinforcement.
Physical frailty
Physical frailty was assessed using the Kihon Checklist (KCL), a 25-item instrument developed by the Japanese Ministry of Health, Labour and Welfare. Total scores range from 0 to 25, with higher scores indicating greater frailty risk. KCL scores were analyzed as continuous variables.
Time frame: From baseline to 6-month and 12-month follow-up
Physical performance
Physical performance was evaluated using the Short Physical Performance Battery (SPPB), which includes balance, gait speed, and chair stand tests. Scores range from 0 to 12, with higher scores indicating better lower-extremity function.
Time frame: From baseline to 6-month and 12-month follow-up
Dysphagia symptom
Dysphagia symptoms were assessed using the Eating Assessment Tool-10 (EAT-10). Scores range from 0 to 40, with higher scores indicating greater severity of dysphagia symptoms.
Time frame: From baseline to 6-month and 12-month follow-up
Masticatory performance
Objective masticatory performance was assessed using color-changing chewing gum (Lotte, Tokyo, Japan). Participants were instructed to chew the gum for 2 minutes, after which the color change was evaluated using a standardized 10-point scale. Higher scores indicate better masticatory performance. Scores were treated as continuous variables for analysis.
Time frame: From baseline to 6-month and 12-month follow-up
Tongue pressure
Maximum tongue pressure was measured at anterior and posterior regions using a digital tongue pressure device (JMS, Hiroshima, Japan). The mean of three measurements was used for analysis. Higher values indicate greater tongue strength.
Time frame: From baseline to 6-month and 12-month follow-up
Subjective chewing ability
Subjective masticatory ability was assessed using a culturally adapted food-based chewing checklist. Eleven commonly consumed food items in Taiwan were selected and categorized into three groups (fruits; seafood and meat; vegetables and plant-based foods). Participants reported their ability to chew each item as "easy," "some difficulty," or "unable." The proportion reporting "easy" was calculated.
Time frame: From baseline to 6-month and 12-month follow-up
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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