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Efficacy of Oral Exercise Training in Oral Frailty

C

China Medical University

Status

Completed

Conditions

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

Treatments

Behavioral: oral function training

Study type

Interventional

Funder types

Other

Identifiers

NCT06926426
CMUH111-REC3-070

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 2 patient groups

Oral Training Intervention Group
Experimental group
Description:
Oral function training (12-week program)
Treatment:
Behavioral: oral function training
Usual Care Group
No Intervention group
Description:
None (participants receive standard care only)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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