Efficacy of Oral Exercise Training in Oral Frailty

NCT ID: NCT06926426

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2024-07-15

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Oral Training Intervention Group

Oral function training (12-week program)

Group Type: EXPERIMENTAL

oral function training

Intervention Type: BEHAVIORAL

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

Usual Care Group

None (participants receive standard care only)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH111-REC3-070

Identifier Type: -

Identifier Source: org_study_id