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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06328244
Other study ID # Community-Based Swallowing
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date June 2024

Study information

Verified date April 2024
Source Chao Phya Abhaibhubejhr Hospital
Contact Qianyun Ce
Phone 15333866454
Email linchuangzhuce@163.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 280
Est. completion date June 2024
Est. primary completion date June 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:
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
Copka Sonpashan

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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