Dysphagia
Conditions
Brief 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?
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.
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.
Sponsors
Zeng Changhao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dysphagia Outcome and Severity Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aspiratory cough | 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. |
| Nutrition Risk Screening 2002 | 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. |
| Dysphagia Handicap Index | 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. |
| Penetration-Aspiration Scale | 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. |
| Aspiration pneumonia | 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. |
| 10-item Eating assessment tool | 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. |
Countries
China
Contacts
CONTACTXi Zeng, PhD
STUDY_DIRECTORXi Zeng, PhD
ZZU First Hospital
Outcome results
None listed