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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simple swallowing training program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Zeng, PhD | Contact | 15333828388 | zengxikangfu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xi Zeng, PhD | ZZU First Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaoxin Qu | Suzhou | China |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42062933 | Derived | 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. doi: 10.1186/s12877-026-07562-z. Online ahead of print. |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Active non-swallowing training | Behavioral | 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. |
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| 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. | 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. | 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. | 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. | 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. | day 0, day 31, day 183 and day 366 |
| Huiji Jinshui Gaoxin Erqi Qu | Zhenzhou | China |
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| D010038 | Otorhinolaryngologic Diseases |