Clinical trial NCT06926426: Efficacy of Oral Exercise Training in Oral Frailty
Official title: Efficacy of Oral Exercise Training in Oral Frailty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly (People Aged 65 or More)
Swallowing Training on Muscle Strength
Dysphagia
Keywords: Oral frailty
oral exercise training
ultrasound
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Hyoid Bone Displacement
timeFrame: Baseline and Week 12
measure: Tongue pressure
timeFrame: At baseline and after 12 weeks of intervention
Secondary outcomes:
measure: Eating Assessment Tool-10 (EAT-10) Score
timeFrame: Baseline and after 12 weeks
measure: Handgrip Strength
timeFrame: Baseline and after 12 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: