Program of Community Oral Function Enhancement | NCT06794814

Studies
Program of Community Oral Function Enhancement

NCT06794814

Sponsor

National Yang Ming Chiao Tung University

Status

Completed

Last Update Posted

Jan 27, 2025Actual

Enrollment

77Actual

Phase

Not Applicable

Conditions

Oral Hypofunction

Interventions

oral exercise

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 24, 2024Actual

Primary Completion Date

Jul 30, 2024Actual

Completion Date

Jul 30, 2024Actual

First Submitted Date

Jan 16, 2025

First Submission Date that Met QC Criteria

Jan 22, 2025

First Posted Date

Jan 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2025

Last Update Posted Date

Jan 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention group	Experimental		Behavioral: oral exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral exercise	Behavioral	The oral exercise protocol included several physical components, namely neck and shoulder stretching, cheek puffing exercises, tongue exercises, salivary gland massage, and oral diadochokinesis.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oral Function Improvement Through Oral Exercise: Gender Differences in Community-Dwelling Older Adults		six weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

over the age of 65

Exclusion Criteria:

incomplete data
failed to perform the assigned daily exercise
unable to adhere to the protocol and steps outline in the oral exercise video

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ming-Lun Hsu, Distinguished professor	National Yang Ming Chiao Tung University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Yang Ming Chiao Tung University		Taipei		112	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40597739	Derived	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.

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena