Efficacy of Oral Exercise Training in Oral Frailty

NCT06926426 | Completed

• 1 other identifier: CMUH111-REC3-070
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Oral frailty; oral exercise training; ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Eating Assessment Tool-10 (EAT-10) Score

  Baseline and after 12 weeks

• Handgrip Strength

  Baseline and after 12 weeks

Study Arms (2)

Oral Training Intervention Group

EXPERIMENTAL

Oral function training (12-week program)

Behavioral: oral function training

Usual Care Group

NO INTERVENTION

None (participants receive standard care only)

Interventions

oral function training BEHAVIORAL

A 12-week program including oral muscle strengthening, pronunciation drills, and swallowing-related exercises designed to improve oral function in older adults.

Oral Training Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Currently consuming food orally

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: September 25, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

TW (1)