Oral HypofunctionNCT06794814
Program of Community Oral Function Enhancement
A study testing oral exercise in people with Oral Hypofunction, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The purpose of this study examined the effects of oral exercise on oral function among older adults in Taiwan, focusing on gender-related outcome differences. Seventy-seven community-dwelling older adults aged 65 and above participated in a six-week oral exercise program, performed before each meal. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Hypofunction
- What is being tested?
- oral exercise
- 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
- 77 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Mar 2024to 30 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- over the age of 65
Who cannot join
- incomplete data
- failed to perform the assigned daily exercise
- unable to adhere to the protocol and steps outline in the oral exercise video
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Function Improvement Through Oral Exercise: Gender Differences in Community-Dwelling Older Adults
The purpose of this study examined the effects of oral exercise on oral function among older adults in Taiwan, focusing on gender-related outcome differences.
Seventy-seven community-dwelling older adults aged 65 and above participated in a six-week oral exercise program, performed before each meal.
After six-week, the participants were examed the salivary secretion, swallowing ability (RSST), oral diadochokinesis, bite force, quality of life (assessed by OHIP-14) and EAT-10.
Read the detailed description
Objective: Elderly individuals with systemic diseases and disabilities face an elevated mortality risk, with oral functional decline further contributing to both oral and systemic health challenges. Given the rising prevalence of reduced oral function in older adults, this study aims to evaluate the effectiveness of oral exercise training on improving oral function and preventing functional decline. Additionally, the study examines potential gender differences in response to the intervention.
Methods: Seventy-seven community-dwelling older adults aged 65 and above participated in a six-week oral exercise program, performed before each meal. The study measured changes in oral function post-intervention.
- Conditions
- Oral Hypofunction
- Being tested
- oral exercise
- Keywords
- Oral exercises, community-dwelling elderly, oral function, prevention of chewing and swallowing disorders
- 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 exerciseBehavioural
The oral exercise protocol included several physical components, namely neck and shoulder stretching, cheek puffing exercises, tongue exercises, salivary gland massage, and oral diadochokinesis.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Behavioral: oral exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Function Improvement Through Oral Exercise: Gender Differences in Community-Dwelling Older Adults
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start24 Mar 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HypofunctionStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Lun Hsu, Distinguished professor, Study director, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794814
- Sponsor's protocol ID
- NYCU113040AF
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsai FT, Romalee W, Ko FW, Lui MT, Hsu ML. Oral function improvement through oral exercise: gender differences in community-dwelling older adults. BMC Geriatr. 2025 Jul 1;25(1):432. doi: 10.1186/s12877-025-06134-x.
PubMed 40597739
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Function Improvement Through Oral Exercise: Gender Differences in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT06794814
- Acronym / sponsor ID
- NYCU113040AF
- Conditions
- Oral Hypofunction
- Keywords
- Oral exercises, community-dwelling elderly, oral function, prevention of chewing and swallowing disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 27 Jan 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.
The purpose of this study examined the effects of oral exercise on oral function among older adults in Taiwan, focusing on gender-related outcome differences.
Seventy-seven community-dwelling older adults aged 65 and above participated in a six-week oral exercise program, performed before each meal.
After six-week, the participants were examed the salivary secretion, swallowing ability (RSST), oral diadochokinesis, bite force, quality of life (assessed by OHIP-14) and EAT-10.
Detailed description
Objective: Elderly individuals with systemic diseases and disabilities face an elevated mortality risk, with oral functional decline further contributing to both oral and systemic health challenges. Given the rising prevalence of reduced oral function in older adults, this study aims to evaluate the effectiveness of oral exercise training on improving oral function and preventing functional decline. Additionally, the study examines potential gender differences in response to the intervention.
Methods: Seventy-seven community-dwelling older adults aged 65 and above participated in a six-week oral exercise program, performed before each meal. The study measured changes in oral function post-intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: oral exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- over the age of 65
Key exclusion criteria (3 listed)
- incomplete data
- failed to perform the assigned daily exercise
- unable to adhere to the protocol and steps outline in the oral exercise video
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 exerciseThe oral exercise protocol included several physical components, namely neck and shoulder stretching, cheek puffing exercises, tongue exercises, salivary gland massage, and oral diadochokinesis. | Behavioural | intervention group |
Primary outcome
Oral Function Improvement Through Oral Exercise: Gender Differences in Community-Dwelling Older Adults
Time frame: six 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 27 Jan 2025.
- Derived from this study: PubMed 40597739Tsai FT, Romalee W, Ko FW, Lui MT, Hsu ML. Oral function improvement through oral exercise: gender differences in community-dwelling older adults. BMC Geriatr. 2025 Jul 1;25(1):432. doi: 10.1186/s12877-025-06134-x.
- Individual participant dataSharing planned: No
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.
Ming-Lun Hsu, Distinguished professor study director
National Yang Ming Chiao Tung University
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 exercise in people with Oral Hypofunction, run by National Yang Ming Chiao Tung University 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 1 inclusion and 3 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 27 Jan 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?
Oral Function Improvement Through Oral Exercise: Gender Differences in Community-Dwelling Older Adults (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06794814, which also lists 1 linked publication.
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 27 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.