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Efficacy of Oral Exercise Training in Oral Frailty

Efficacy of Oral Exercise Training in Oral Frailty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06926426
Enrollment
58
Registered
2025-04-13
Start date
2023-09-25
Completion date
2024-07-15
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Oral frailty, oral exercise training, ultrasound

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.

Interventions

BEHAVIORALoral function training

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

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hyoid Bone DisplacementBaseline and Week 12Change in hyoid bone displacement during swallowing assessed by ultrasound
Tongue pressureAt baseline and after 12 weeks of interventionChange in maximum anterior tongue pressure measured using the IOPI device

Secondary

MeasureTime frameDescription
Eating Assessment Tool-10 (EAT-10) ScoreBaseline and after 12 weeksThe 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 StrengthBaseline and after 12 weeksChange in maximum grip strength measured by dynamometer

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026