Simple Swallowing Training Program on Older Individuals in the Community (SSTP1year)

Zeng Changhao

Status: Not yet enrolling

Conditions: Dysphagia

Treatments: Behavioral: Simple swallowing training program; Behavioral: Active non-swallowing training

Study type: Interventional

Funder types: Other

Identifiers

NCT07373028

SSTPlongterm

Details and patient eligibility

About

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?

Full 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.

Enrollment: 474 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

• 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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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474 participants in 2 patient groups

Simple swallowing training program group

Experimental group

Description:

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.

Treatment:

Behavioral: Simple swallowing training program

Active control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active non-swallowing training