A Randomized Controlled Trial to Explore the Long-term Effects of a Simple Swallowing Training Program on Older Individuals in the Community
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Zeng Changhao
- 入组人数
- 474
- 试验地点
- 2
- 主要终点
- Dysphagia Outcome and Severity Scale
概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Simple swallowing training program group
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.
干预措施: Simple swallowing training program (Behavioral)
Active control group
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.
干预措施: Active non-swallowing training (Behavioral)
结局指标
主要结局
Dysphagia Outcome and Severity Scale
时间窗: 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.
次要结局
- Aspiratory cough(1 year)
- Nutrition Risk Screening 2002(day 0, day 183 and day 366)
- Dysphagia Handicap Index(day 0, day 31, day 183 and day 366)
- Penetration-Aspiration Scale(day 0 and day 366)
- Aspiration pneumonia(1 year)
- 10-item Eating assessment tool(day 0, day 31, day 183 and day 366)
研究者
Zeng Changhao
Principle Investigator
People's Hospital of Zhengzhou University