Elderly (People Aged 65 or More)NCT06926426
Efficacy of Oral Exercise Training in Oral Frailty
A study testing oral function training in people with Elderly (People Aged 65 or More) and Swallowing Training on Muscle Strength, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly (People Aged 65 or More), Swallowing Training on Muscle Strength, Dysphagia
- What is being tested?
- oral function training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Sep 2023to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Currently consuming food orally
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- oral function training
- Keywords
- Oral frailty, oral exercise training, ultrasound
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral function trainingBehavioural
A 12-week program including oral muscle strengthening, pronunciation drills, and swallowing-related exercises designed to improve oral function in older adults.
| Study group | Role | What they receive |
|---|---|---|
| Oral Training Intervention Group | Experimental | Oral function training (12-week program) Receives: Behavioral: oral function training |
| Usual Care Group | No intervention | None (participants receive standard care only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyoid Bone Displacement
Change in hyoid bone displacement during swallowing assessed by ultrasound
Measured: Baseline and Week 12
Tongue pressure
Change in maximum anterior tongue pressure measured using the IOPI device
Measured: At baseline and after 12 weeks of intervention
Secondary outcomes (2)
Eating Assessment Tool-10 (EAT-10) Score
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
Measured: Baseline and after 12 weeks
Handgrip Strength
Change in maximum grip strength measured by dynamometer
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start25 Sep 2023
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly (People Aged 65 or More)Studies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926426
- Sponsor's protocol ID
- CMUH111-REC3-070
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Exercise Training in Oral Frailty
- ClinicalTrials.gov ID
- NCT06926426
- Acronym / sponsor ID
- CMUH111-REC3-070
- Keywords
- Oral frailty, oral exercise training, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Training Intervention Group | Experimental | Behavioral: oral function trainingOral function training (12-week program) |
| Usual Care Group | No intervention | –None (participants receive standard care only) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years or older
- Currently consuming food orally
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral function trainingA 12-week program including oral muscle strengthening, pronunciation drills, and swallowing-related exercises designed to improve oral function in older adults. | Behavioural | Oral Training Intervention Group |
Primary outcome
Hyoid Bone Displacement
Time frame: Baseline and Week 12
Change in hyoid bone displacement during swallowing assessed by ultrasound
Tongue pressure
Time frame: At baseline and after 12 weeks of intervention
Change in maximum anterior tongue pressure measured using the IOPI device
2 secondary outcomes
Eating Assessment Tool-10 (EAT-10) Score
Time frame: Baseline and after 12 weeks
Handgrip Strength
Time frame: Baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral function training in people with Elderly (People Aged 65 or More) and Swallowing Training on Muscle Strength, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyoid Bone Displacement (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.