Oral FrailtyNCT07550335
Group Reading and Oral Exercise Program for Older Adults
A study testing Reading and Oral Exercise Program in people with Oral Frailty and Depression, run by Mackay Memorial Hospital.
Trial summary
Depression is common among older adults and is often associated with declines in physical and oral health. Non-pharmacological, community-based interventions are needed to support both mental and physical well-being. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Frailty, Depression, Sarcopenia
- What is being tested?
- Reading and Oral Exercise Program
- 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
- 60 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling adults aged 55 years and older.
- Able to communicate in Mandarin or Taiwanese and capable of understanding study instructions and participating in group discussions.
- Able to complete study questionnaires independently or with assistance from research staff.
Who cannot join
- Individuals with severe cognitive impairment that precludes understanding study procedures or participation in group discussions.
- Individuals with a current diagnosis of severe psychiatric disorders (e.g., schizophrenia, acute phase of bipolar disorder) that would make participation in group activities inappropriate.
- Individuals who have participated in similar psychological or bibliotherapy-based interventions within the past 3 months.
About this study
Official title: Effects of a Focus Group-Based Bibliotherapy Intervention Combined With Oral Exercises on Oral Frailty, Physical Function, Grit, and Depression in Community-Dwelling Older Adults
Depression is common among older adults and is often associated with declines in physical and oral health. Non-pharmacological, community-based interventions are needed to support both mental and physical well-being. This study examines the effects of a program combining group-based reading activities and oral exercises in community-dwelling older adults. Participants are randomly assigned to either an intervention group, which receives the six-week program, or a control group receiving general oral health education. The study evaluates whether the intervention can improve physical and oral function, enhance psychological resilience (grit), and reduce depressive symptoms.
- Conditions
- Oral Frailty, Depression, Sarcopenia, Physical Function Decline
- Being tested
- Reading and Oral Exercise Program
- Medical subject headings
- Depression, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading and Oral Exercise ProgramBehavioural
Participants in the intervention group receive a combined program of group-based reading activities and oral exercises. The program is delivered in a focus group format and includes guided reading discussions to promote emotional expression and reflection, along with structured oral exercises to enhance oral muscle function. The intervention is conducted over a 6-week period, with sessions held once every two weeks for a total of three sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Reading and Oral Exercise Program |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Depressive symptoms measured using the Geriatric Depression Scale (GDS), with higher scores indicating more severe depressive symptoms.
Measured: At baseline and immediately after the 6-week intervention period
Secondary outcomes (3)
Oral Frailty
Oral frailty assessed using the Oral Frailty Index, with higher scores indicating greater oral frailty.
Measured: At baseline and immediately after the 6-week intervention period
Sarcopenia Risk
Sarcopenia risk assessed using the SARC-F questionnaire, with higher scores indicating greater risk of sarcopenia
Measured: At baseline and immediately after the 6-week intervention period
Grit
Grit assessed using the Grit Scale, with higher scores indicating greater perseverance and consistency of interest.
Measured: At baseline and immediately after the 6-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start23 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral FrailtyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550335
- Sponsor's protocol ID
- 26MMHIS046e
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 24 Apr 2026
- 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 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Focus Group-Based Bibliotherapy Intervention Combined With Oral Exercises on Oral Frailty, Physical Function, Grit, and Depression in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT07550335
- Acronym / sponsor ID
- 26MMHIS046e
- Conditions
- Oral Frailty, Depression, Sarcopenia, Physical Function Decline
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 23 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Apr 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.
Depression is common among older adults and is often associated with declines in physical and oral health. Non-pharmacological, community-based interventions are needed to support both mental and physical well-being. This study examines the effects of a program combining group-based reading activities and oral exercises in community-dwelling older adults. Participants are randomly assigned to either an intervention group, which receives the six-week program, or a control group receiving general oral health education. The study evaluates whether the intervention can improve physical and oral function, enhance psychological resilience (grit), and reduce depressive symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Reading and Oral Exercise Program |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Community-dwelling adults aged 55 years and older.
- Able to communicate in Mandarin or Taiwanese and capable of understanding study instructions and participating in group discussions.
- Able to complete study questionnaires independently or with assistance from research staff.
Key exclusion criteria (3 listed)
- Individuals with severe cognitive impairment that precludes understanding study procedures or participation in group discussions.
- Individuals with a current diagnosis of severe psychiatric disorders (e.g., schizophrenia, acute phase of bipolar disorder) that would make participation in group activities inappropriate.
- Individuals who have participated in similar psychological or bibliotherapy-based interventions within the past 3 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 |
|---|---|---|
| Reading and Oral Exercise ProgramParticipants in the intervention group receive a combined program of group-based reading activities and oral exercises. The program is delivered in a focus group format and includes guided reading discussions to promote emotional expression and reflection, along with structured oral exercises to enhance oral muscle function. The intervention is conducted over a 6-week period, with sessions held once every two weeks for a total of three sessions. | Behavioural | Intervention Group |
Primary outcome
Depressive Symptoms
Time frame: At baseline and immediately after the 6-week intervention period
Depressive symptoms measured using the Geriatric Depression Scale (GDS), with higher scores indicating more severe depressive symptoms.
3 secondary outcomes
Oral Frailty
Time frame: At baseline and immediately after the 6-week intervention period
Sarcopenia Risk
Time frame: At baseline and immediately after the 6-week intervention period
Grit
Time frame: At baseline and immediately after the 6-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reading and Oral Exercise Program in people with Oral Frailty and Depression, run by Mackay Memorial Hospital.
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 3 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: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Depressive Symptoms (time frame: At baseline and immediately after the 6-week intervention period). 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 2026.