Efficacy of Oral Exercise Training in Oral Frailty

Not Applicable

Completed

• Conditions: Elderly (People Aged 65 or More); Swallowing Training on Muscle Strength; Dysphagia

• Registration Number: NCT06926426
• Lead Sponsor: China Medical University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-25
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Study First Posted: 2025-04-13
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Eating Assessment Tool-10 (EAT-10) Score	Baseline and after 12 weeks	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
Handgrip Strength	Baseline and after 12 weeks	Change in maximum grip strength measured by dynamometer

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan