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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06301594
Other study ID # Dys-prevent
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date March 2024

Study information

Verified date March 2024
Source Ahmadu Bello University Teaching Hospital
Contact Lavie Ce, Master
Phone 15333828388
Email zenghongjixx@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.


Description:

The investigators have designed a simple and user-friendly swallowing rehabilitation training method called "systematic simple swallowing training" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. It has shown promising preliminary efficacy. However, before we can promote its widespread adoption, a series of studies must be conducted to establish its effectiveness. The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Age over 60 years old. - No hospitalization within the past six months. - With clear consciousness and able to cooperate with questionnaires and training. - The elderly people who voluntarily participate and agree to adhere until the end of the study. Exclusion Criteria: - Complicated with severe liver and kidney failure, tumors, or hematological disorders. - Physical disability. - Difficulty in mobility.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Systematic simple swallowing training
Systematic simple swallowing training includes the following: Warm-up: including joint activities, chest expansion exercise, etc., totally 5 minutes. Cognitive swallowing training: play video of food programs for five minutes. Lip training: Bounce the upper and lower lips to make a "bo" sound. 30-60 seconds. Tongue training: Do the upper, lower, left, and right four-directional movements of the tongue muscle. 30-60 seconds. Mandibular training: slowly open r mouth to the maximum, then slowly close it. 30-60 seconds. Soft palate training: Make the sounds of g, k, and h for 1-2 minutes. Cheek puffing training: Close lips tightly and puff cheeks. 30-60 seconds. Swallowing training: We require the elderly to swallow small amounts of water intermittently and forcefully for 2-5 times. Completing the above content in succession is called a round, and each training session includes 2-3 rounds. 2 sessions a day. Five days a week

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Muhammad

Outcome

Type Measure Description Time frame Safety issue
Primary Swallowing-Related Quality of Life Questionnaire The Swallowing-Related Quality of Life Questionnaire (SWAL-QOL) is a validated tool used to assess the impact of swallowing difficulties on quality of life. It is a 44-item questionnaire designed to measure the physical, emotional, and social domains of swallowing-related quality of life.The higher final scores indicate the better life quality. The total score will be converted into a standard percentage day 1 and day 21
Secondary Eating Assessment Tool-10 Eating Assessment Tool-10 is a scale used to evaluate swallowing function problems, and is one of the commonly used tools for assessing the swallowing ability of elderly individuals. Eating Assessment Tool-10 stands for 'Eating Assessment Tool-10', and was developed by professional medical institutions in the United States with the aim of quickly assessing potential difficulties and problems during the process of swallowing.The Eating Assessment Tool-10 scale consists of 10 questions that cover different aspects of swallowing function. Each question has a rating score ranging from 0 to 4, indicating the severity of difficulty in swallowing, with 0 representing no problem and 4 representing severe difficulty. The higher the total score, the more severe the swallowing function problem. day 1 and day 21
Secondary Time consumed in eating We require participants to eat a lunch according to their daily intake and habits, and count the time consumed day 1 and day 21
Secondary Standardized Swallowing Assessment Standardized Swallowing Assessment is a standardized scale used to assess swallowing function, primarily targeting the evaluation of swallowing disorders. It typically includes various items such as oral, tongue, and pharyngeal muscle movements, swallowing coordination, and smoothness. The total scores rang from 18 to 42. A higher total score indicates better swallowing function. day 1 and day 21
Secondary Water Swallow Test The Water Swallow Test was recruited to assess swallowing function in patients at admission. Specifically, patients were instructed to sit and drink 30 ml of warm water. A 5-point scoring system is used as follows:
Point: Successful swallowing of water within 5 seconds without coughing. Points: Able to swallow the water once but taking more than 5 seconds or swallowing in two or more attempts without coughing.
Points: Able to swallow the water once with coughing. Points: Able to swallow the water in two or more attempts with coughing. Points: Unable to swallow all of the water, frequent coughing. The higher points indicate the worse swallowing function
day 1 and day 21
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