DysphagiaSSTP1yearNCT07373028
Simple Swallowing Training Program on Older Individuals in the Community
A study testing Simple swallowing training program and Active non-swallowing training in people with Dysphagia, run by Zeng Changhao at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Simple swallowing training program and Active non-swallowing training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2026to Jun 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Gaoxin Qu
Suzhou
Ying Yang, 13323856864, yangying@126.com
Huiji Jinshui Gaoxin Erqi Qu
Zhenzhou
Yi Li, PhD, 13592505588, muzili2025@163.com
About this study
Official title: A Randomized Controlled Trial to Explore the Long-term Effects of a Simple Swallowing Training Program on Older Individuals in the Community
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.
- Conditions
- Dysphagia
- Being tested
- Simple swallowing training program, Active non-swallowing training
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple swallowing training programBehavioural
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.
Active non-swallowing trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active non-swallowing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 0 and day 366
Secondary outcomes (6)
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.
Measured: 1 year
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.
Measured: day 0, day 183 and day 366
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.
Measured: day 0, day 31, day 183 and day 366
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.
Measured: day 0 and day 366
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.
Measured: 1 year
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.
Measured: day 0, day 31, day 183 and day 366
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Xi Zeng, PhD, Study director, ZZU First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373028
- Sponsor's protocol ID
- SSTPlongterm
- Acronym
- SSTP1year
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Explore the Long-term Effects of a Simple Swallowing Training Program on Older Individuals in the Community
- ClinicalTrials.gov ID
- NCT07373028
- Acronym / sponsor ID
- SSTP1year / SSTPlongterm
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Jan 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.
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?
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple swallowing training program group | Experimental | Behavioral: Simple swallowing training programOlder 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. |
| Active control group | Active comparator | Behavioral: Active non-swallowing trainingParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- Self-reported medical condition precluding exercise.
- Physical disability.
- Abnormalities of the oral, pharyngeal, or esophageal structures.
- Diagnosis of aspiration pneumonia.
- Presence of a tracheostomy
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 |
|---|---|---|
| Simple swallowing training programThe 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. | Behavioural | Simple swallowing training program group |
| Active non-swallowing trainingA 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. | Behavioural | Active control group |
Primary outcome
Dysphagia Outcome and Severity Scale
Time frame: day 0 and day 366
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.
6 secondary outcomes
Aspiratory cough
Time frame: 1 year
Nutrition Risk Screening 2002
Time frame: day 0, day 183 and day 366
Dysphagia Handicap Index
Time frame: day 0, day 31, day 183 and day 366
Penetration-Aspiration Scale
Time frame: day 0 and day 366
Aspiration pneumonia
Time frame: 1 year
10-item Eating assessment tool
Time frame: day 0, day 31, day 183 and day 366
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 28 Jan 2026.
- Derived from this study: PubMed 42062933Zhang 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.
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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.
Xi Zeng, PhD study director
ZZU First Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple swallowing training program and Active non-swallowing training in people with Dysphagia, run by Zeng Changhao at 2 sites in China.
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 7 inclusion and 7 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Xi Zeng, PhD (15333828388, zengxikangfu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia Outcome and Severity Scale (time frame: day 0 and day 366). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07373028, which also lists 1 linked publication.
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 28 Jan 2026.