NCT Number: NCT07373028
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 opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Gaoxin Qu, Suzhou, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 1 year
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: day 0, day 183 and day 366
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 31, day 183 and day 366
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 and day 366
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: 1 year
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: day 0, day 31, day 183 and day 366
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.
Contact information is provided by the study sponsor or research team.
Zeng Changhao
Other
A Randomized Controlled Trial to Explore the Long-term Effects of a Simple Swallowing Training Program on Older Individuals in the Community
Acronym: SSTP1year
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