NCT07373028

Brief Summary

The goal of this clinical trial is to explore the effects of a simple swallowing training program on the swallowing function, airway protection, nutritional risk, daily choking, quality of life, and mental health of elderly individuals with mild swallowing difficulties residing in the community. The main question it aims to answer is: Does the simple swallowing training program significantly improve participants' swallowing function and safety, as well as their quality of life? Additionally, can daily choking incidents be improved?

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
474

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Feb 2026Jun 2027

First Submitted

Initial submission to the registry

January 12, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 12, 2026

Last Update Submit

January 22, 2026

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

  • Dysphagia Outcome and Severity Scale

    The Dysphagia Outcome and Severity Scale consists of 7 levels, from 1 to 7, based on imaging data. A higher level indicates better swallowing function.

    day 0 and day 366

Secondary Outcomes (6)

  • Aspiratory cough

    1 year

  • Nutrition Risk Screening 2002

    day 0, day 183 and day 366

  • Dysphagia Handicap Index

    day 0, day 31, day 183 and day 366

  • Penetration-Aspiration Scale

    day 0 and day 366

  • Aspiration pneumonia

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Simple swallowing training program group

EXPERIMENTAL

Older individuals will be assigned to the simple swallowing training program, with rest on weekends, and training conducted only on weekdays, twice a day for 15 minutes each time. Each training session will take place approximately one hour before meals. Online guidance services will be provided by the researchers.

Behavioral: Simple swallowing training program

Active control group

ACTIVE COMPARATOR

Participants in the active control group are assigned to physical activities that correspond to the amount, frequency, and duration of the simple swallowing training program. These activities are designed to minimize any impact on swallowing function while being considered sufficient to reduce the potential effects associated with physical activity. Online guidance services will be provided by the researchers.

Behavioral: Active non-swallowing training

Interventions

Simple swallowing training programBEHAVIORAL

The Simple swallowing training program included warm-up and another 11 sections, including Warm-up for 3 min, Neck Activation for 1 min, Nod for 1 min, Lip Closure for 1 min, Cheek Puffing for 1 min, Breathing Exercise for 1 min, Voice Training for 2 min, Swallowing Exercise for 2-3 min, Neck Massage for 1 min, Acupressure for 2 min, Facial Massage for 3 min and Tongue Exercise for 1 min.

Simple swallowing training program group
Active non-swallowing trainingBEHAVIORAL

A set of light physical activities that will not affect swallowing function, lasting approximately 15 minutes, similar to the simple swallowing training program and requiring no equipment.

Active control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 years or older and living in communities.
  • Speaking Chinese
  • Daily oral feeding.
  • The swallowing risk was detected through the Volume-Viscosity Swallow Test, and mild dysphagia based on Dysphagia Outcome and Severity Scale
  • No history of hospitalization in the past 6 months.
  • No participation in any swallowing-related intervention in the past 6 months.
  • Conscious and able to cooperate with questionnaires and training.

You may not qualify if:

  • Self-reported medical condition precluding exercise.
  • Physical disability.
  • Abnormalities of the oral, pharyngeal, or esophageal structures.
  • Diagnosis of aspiration pneumonia.
  • Presence of a tracheostomy
  • Neuromuscular disorders
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaoxin Qu

Suzhou, China

Location

Huiji Jinshui Gaoxin Erqi Qu

Zhenzhou, China

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Xi Zeng, PhD

    ZZU First Hospital

    STUDY DIRECTOR

Central Study Contacts

Xi Zeng, PhD

CONTACT

15333828388zengxikangfu@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 28, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

CN(2)