CClinicalTrials.gg
Not yet recruitingNCT07373028SSTP1yearUpdated Jan 28, 2026

Simple Swallowing Training Program on Older Individuals in the Community

An interventional study of Simple swallowing training program and Active non-swallowing training in Dysphagia, sponsored by Zeng Changhao. Not yet recruiting at 2 sites in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by Zeng Changhao · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
474
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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?

Read the detailed description

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? Additionally, the investigator will compare the long-term effects of the training with the previous study to see the significance of long-term training.

02

Conditions studied

  • Dysphagia

Browse trials for

03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
474 participants (estimated)

Study arms

  • Experimental
    Simple swallowing training program group

    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 comparator
    Active control group

    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

  • BehavioralSimple swallowing training program

    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.

  • BehavioralActive non-swallowing training

    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.

05

What researchers measure

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.

    Time frame: day 0 and day 366

Secondary outcomes

  1. Aspiratory cough

    Aspiratory cough is based on self-reporting and recorded via paper or electronic calendars, which are periodically uploaded. Cough is defined as the coughing and discomfort caused by food or water entering the airway for various reasons. The outcomes of choking include relief through actions such as coughing or patting the back, or no relief at all.

    Time frame: 1 year

  2. Nutrition Risk Screening 2002

    Nutrition Risk Screening 2002 is a tool used to assess nutritional risk. The total score ranges from 0 to 7, with a score of 3 or higher indicating the presence of nutritional risk.

    Time frame: day 0, day 183 and day 366

  3. Dysphagia Handicap Index

    Dysphagia Handicap Index is used to assess quality of life. The total score ranges from 0 to 100, with the higher score indicating worse quality of life.

    Time frame: day 0, day 31, day 183 and day 366

  4. Penetration-Aspiration Scale

    Penetration-Aspiration Scale is used to assess airway protection. The total score ranges from 1 to 8, with the higher score indicating worse airway protection.

    Time frame: day 0 and day 366

  5. Aspiration pneumonia

    Participants are monitored for the occurrence of aspiration pneumonia, with the standard being the diagnosis issued by the hospital. It is considered that a participant may experience aspiration pneumonia multiple times within a year. Based on imaging results, aspiration pneumonia resulting from the same incident of aspiration is regarded as the same positive case. Participants or their relatives are required to regularly submit information regarding their pneumonia.

    Time frame: 1 year

  6. 10-item Eating assessment tool

    10-item Eating assessment tool was used to assess subject swallowing ability. The total score ranges from 0 to 40, with the higher score indicating more severe subject swallowing disorders.

    Time frame: day 0, day 31, day 183 and day 366

06

Study locations

2 sites
  • Gaoxin Qu
    Suzhou, China
  • Huiji Jinshui Gaoxin Erqi Qu
    Zhenzhou, China
07

References and documents

Publications

  • Zhang C, Yang Y, Zhu X, Liu H, Zuo T, Yan S, Zhao W, Luo S, Zeng H, Zeng X. Effect of the year-round simple swallowing training program in community-dwelling older people with mild oropharyngeal dysphagia: study protocol for a randomized controlled trial. BMC Geriatr. 2026 Apr 30;26(1):851. doi: 10.1186/s12877-026-07562-z. PubMed 42062933 ↗
08

Registry details

Key details

Study ID
NCT07373028
Lead sponsor
Zeng Changhao
Responsible party
Zeng Changhao (Principle Investigator, People's Hospital of Zhengzhou University) — Sponsor-investigator
First posted
Jan 28, 2026
Start date
Feb 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jan 28, 2026

Study contacts

Xi Zeng, PhD
Contact
zengxikangfu@126.com
15333828388
Xi Zeng, PhD
study director · ZZU First Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion