Frailty at Older AdultsNCT07866781
Oral Function Intervention in Community-Dwelling Older Adults
A study testing Integrated Oral Function Intervention in people with Frailty at Older Adults and Mastication, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Oral frailty is a potentially reversible condition associated with physical frailty and functional decline in older adults. Interventions targeting oral function may therefore improve broader physical health. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty at Older Adults, Mastication, Physical Functional Performance
- What is being tested?
- Integrated Oral Function Intervention
- 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
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2025to 31 May 2026
- 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
- Community-dwelling adults aged 65 years or older
- Who were able to communicate independently and participate in oral functional assessments and group activities.
Who cannot join
- Complete edentulism without denture use
- Reported food allergies
- Severe renal disease, or severe dysphagia that would preclude safe participation in the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The CAMCAM Dietary Program
Oral frailty is a potentially reversible condition associated with physical frailty and functional decline in older adults. Interventions targeting oral function may therefore improve broader physical health. This study aim to evaluate oral and physical functional changes after a 6-month integrated intervention and compare these changes over 12 months.
- Being tested
- Integrated Oral Function Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Oral Function InterventionBehavioural
The six-month multidisciplinary intervention was tailored for implementation in Taiwanese community settings. Participants were subsequently followed for up to 12 months to evaluate the maintenance of the changes. The intervention was designed as an integrated oral and physical function-based approach to frailty prevention and comprised four core components: (1) health education, (2) integrated physical and oral exercises, (3) masticatory-enhancing textured meals, and (4) digital behavioral reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| Oral function intervention with textured meals | Experimental | Not described Receives: Behavioral: Integrated Oral Function Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical frailty
Physical frailty was assessed using the Kihon Checklist (KCL), a 25-item instrument developed by the Japanese Ministry of Health, Labour and Welfare. Total scores range from 0 to 25, with higher scores indicating greater frailty risk. KCL scores were analyzed as continuous variables.
Measured: From baseline to 6-month and 12-month follow-up
Physical performance
Physical performance was evaluated using the Short Physical Performance Battery (SPPB), which includes balance, gait speed, and chair stand tests. Scores range from 0 to 12, with higher scores indicating better lower-extremity function.
Measured: From baseline to 6-month and 12-month follow-up
Dysphagia symptom
Dysphagia symptoms were assessed using the Eating Assessment Tool-10 (EAT-10). Scores range from 0 to 40, with higher scores indicating greater severity of dysphagia symptoms.
Measured: From baseline to 6-month and 12-month follow-up
Masticatory performance
Objective masticatory performance was assessed using color-changing chewing gum (Lotte, Tokyo, Japan). Participants were instructed to chew the gum for 2 minutes, after which the color change was evaluated using a standardized 10-point scale. Higher scores indicate better masticatory performance. Scores were treated as continuous variables for analysis.
Measured: From baseline to 6-month and 12-month follow-up
Tongue pressure
Maximum tongue pressure was measured at anterior and posterior regions using a digital tongue pressure device (JMS, Hiroshima, Japan). The mean of three measurements was used for analysis. Higher values indicate greater tongue strength.
Measured: From baseline to 6-month and 12-month follow-up
Secondary outcomes (1)
Subjective chewing ability
Subjective masticatory ability was assessed using a culturally adapted food-based chewing checklist. Eleven commonly consumed food items in Taiwan were selected and categorized into three groups (fruits; seafood and meat; vegetables and plant-based foods). Participants reported their ability to chew each item as "easy," "some difficulty," or "unable." The proportion reporting "easy" was calculated.
Measured: From baseline to 6-month and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jun 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty at Older AdultsStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866781
- Sponsor's protocol ID
- CAMCAM_Tainan
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CAMCAM Dietary Program
- ClinicalTrials.gov ID
- NCT07866781
- Acronym / sponsor ID
- CAMCAM_Tainan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 8 Oct 2026 (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.
Oral frailty is a potentially reversible condition associated with physical frailty and functional decline in older adults. Interventions targeting oral function may therefore improve broader physical health. This study aim to evaluate oral and physical functional changes after a 6-month integrated intervention and compare these changes over 12 months.
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 |
|---|---|---|
| Oral function intervention with textured meals | Experimental | Behavioral: Integrated Oral Function Intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Community-dwelling adults aged 65 years or older
- Who were able to communicate independently and participate in oral functional assessments and group activities.
Key exclusion criteria (3 listed)
- Complete edentulism without denture use
- Reported food allergies
- Severe renal disease, or severe dysphagia that would preclude safe participation in the intervention.
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 |
|---|---|---|
| Integrated Oral Function InterventionThe six-month multidisciplinary intervention was tailored for implementation in Taiwanese community settings. Participants were subsequently followed for up to 12 months to evaluate the maintenance of the changes. The intervention was designed as an integrated oral and physical function-based approach to frailty prevention and comprised four core components: (1) health education, (2) integrated physical and oral exercises, (3) masticatory-enhancing textured meals, and (4) digital behavioral reinforcement. | Behavioural | Oral function intervention with textured meals |
Primary outcome
Physical frailty
Time frame: From baseline to 6-month and 12-month follow-up
Physical frailty was assessed using the Kihon Checklist (KCL), a 25-item instrument developed by the Japanese Ministry of Health, Labour and Welfare. Total scores range from 0 to 25, with higher scores indicating greater frailty risk. KCL scores were analyzed as continuous variables.
Physical performance
Time frame: From baseline to 6-month and 12-month follow-up
Physical performance was evaluated using the Short Physical Performance Battery (SPPB), which includes balance, gait speed, and chair stand tests. Scores range from 0 to 12, with higher scores indicating better lower-extremity function.
Dysphagia symptom
Time frame: From baseline to 6-month and 12-month follow-up
Dysphagia symptoms were assessed using the Eating Assessment Tool-10 (EAT-10). Scores range from 0 to 40, with higher scores indicating greater severity of dysphagia symptoms.
Masticatory performance
Time frame: From baseline to 6-month and 12-month follow-up
Objective masticatory performance was assessed using color-changing chewing gum (Lotte, Tokyo, Japan). Participants were instructed to chew the gum for 2 minutes, after which the color change was evaluated using a standardized 10-point scale. Higher scores indicate better masticatory performance. Scores were treated as continuous variables for analysis.
Tongue pressure
Time frame: From baseline to 6-month and 12-month follow-up
Maximum tongue pressure was measured at anterior and posterior regions using a digital tongue pressure device (JMS, Hiroshima, Japan). The mean of three measurements was used for analysis. Higher values indicate greater tongue strength.
1 secondary outcome
Subjective chewing ability
Time frame: From baseline to 6-month and 12-month follow-up
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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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 Integrated Oral Function Intervention in people with Frailty at Older Adults and Mastication, run by Kaohsiung Medical University Chung-Ho Memorial 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 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 8 Oct 2026. 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?
Physical frailty (time frame: From baseline to 6-month and 12-month follow-up). The study lists 5 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 8 Oct 2026.