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Completed

NCT Number: NCT06926426

Efficacy of Oral Exercise Training in Oral Frailty

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, 404, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Hyoid Bone Displacement

    Time frame: Baseline and Week 12

    Change in hyoid bone displacement during swallowing assessed by ultrasound

  2. Tongue pressure

    Time frame: At baseline and after 12 weeks of intervention

    Change in maximum anterior tongue pressure measured using the IOPI device

Secondary outcomes

  1. Eating Assessment Tool-10 (EAT-10) Score

    Time frame: Baseline and after 12 weeks

    The 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

  2. Handgrip Strength

    Time frame: Baseline and after 12 weeks

    Change in maximum grip strength measured by dynamometer

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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