Efficacy of Oral Exercise Training in Oral Frailty

As the elderly grow older, the quality and function of skeletal muscle are affected. Sarcopenia is commonly seen in the elderly, due to the loss of skeletal muscle mass and function, often resulting in loss of activity and weight. Oral frailty refers to the status of oral function decline. Several studies indicate the relationship between sarcopenia and oral frailty, which is assumed to be the predictor of sarcopenia. Oral frailty may also progress to presbyphagia over time, causing higher risk of malnutrition, dehydration, pneumonia, and poor quality of life. In addition, recently, the use of ultrasound can measure the distance and speed of the hyoid bone displacement, thus more clearly assessing the swallowing function. The investigators aim to analyze whether oral exercise training can promote the oral and swallowing performance of the residents with oral frailty, and the feasibility of ultrasound as swallowing function evaluation.

The investigators' study will enroll participants from residential long-term care facilities according to the screening of oral frailty. The participants will be equally arranged to experimental and control groups. The intervention strategies will be given after institutional education training. Oral exercise training will be performed by facility's primary caregiver with professionals' remote supervision for 12 weeks. Evaluation tools include hand grip strength, 6-meter walking test, body composition analysis check (BIA), repeated saliva swallowing test, eating dysfunction scale (EAT-10), Functional Oral Intake Scale (FOIS), quality of life questionnaires, tongue muscle strength test and ultrasound swallowing function test.

Study Overview

• Status: Completed
• Conditions: Dysphagia; Elderly (People Aged 65 or More); Swallowing Training on Muscle Strength
• Intervention / Treatment: Behavioral: oral function training

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 65 years or older
• Currently consuming food orally

Exclusion Criteria:

• Previously diagnosed with dysphagia
• Progressive central nervous system or motor disorders (e.g., dementia, Parkinson's disease)
• New-onset central nervous system disease within the past 6 months (e.g., stroke, traumatic brain injury)
• New-onset head and neck cancer within the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Training Intervention Group; Oral function training (12-week program)	Behavioral: oral function training; A 12-week program including oral muscle strengthening, pronunciation drills, and swallowing-related exercises designed to improve oral function in older adults.
No Intervention: Usual Care Group; None (participants receive standard care only)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyoid Bone Displacement	Change in hyoid bone displacement during swallowing assessed by ultrasound	Baseline and Week 12
Tongue pressure	Change in maximum anterior tongue pressure measured using the IOPI device	At baseline and after 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip Strength	Change in maximum grip strength measured by dynamometer	Baseline and after 12 weeks
Eating Assessment Tool-10 (EAT-10) Score	The Eating Assessment Tool-10 (EAT-10) is a self-administered symptom-specific outcome measure for dysphagia. Scoring Range: 0 to 40 Higher Scores: Indicate worse swallowing function and more severe symptoms	Baseline and after 12 weeks

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; Oral frailty; oral exercise training
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: CMUH111-REC3-070

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No