- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550335
Group Reading and Oral Exercise Program for Older Adults
April 19, 2026 updated by: Mackay Memorial Hospital
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
|
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.
|
|
No Intervention: Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline and immediately after the 6-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral Frailty
Time Frame: At baseline and immediately after the 6-week intervention period
|
Oral frailty assessed using the Oral Frailty Index, with higher scores indicating greater oral frailty.
|
At baseline and immediately after the 6-week intervention period
|
|
Sarcopenia Risk
Time Frame: At baseline and immediately after the 6-week intervention period
|
Sarcopenia risk assessed using the SARC-F questionnaire, with higher scores indicating greater risk of sarcopenia
|
At baseline and immediately after the 6-week intervention period
|
|
Grit
Time Frame: At baseline and immediately after the 6-week intervention period
|
Grit assessed using the Grit Scale, with higher scores indicating greater perseverance and consistency of interest.
|
At baseline and immediately after the 6-week intervention period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 23, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
April 19, 2026
First Submitted That Met QC Criteria
April 19, 2026
First Posted (Actual)
April 24, 2026
Study Record Updates
Last Update Posted (Actual)
April 24, 2026
Last Update Submitted That Met QC Criteria
April 19, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26MMHIS046e
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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