The Impact of Swallowing Intervention for Elderly Community Dwellers

Dysphagia Clinical Trial

Official title:

The Effect of Simple Swallowing Rehabilitation Training for Elderly Community Dwellers: A Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06328231
• Other study ID #: Community elderly dysphagia
• Status: Completed
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: April 14, 2024

Study information

• Verified date: April 2024
• Source: Chao Phya Abhaibhubejhr Hospital
• Contact: n/a
• Is FDA regulated: No
• 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 divided into 2 groups. The intervention group is 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 15-20 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. 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 divided into 2 groups. The intervention group is 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 15-20 minutes each.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: April 14, 2024
• Est. primary completion date: April 14, 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.
• early dysphagia.

Exclusion Criteria:

• Complicated with severe liver and kidney failure, tumors, or hematological disorders.
• Physical disability.
• Difficulty in mobility.
• Simultaneously receiving other therapies that might influence this study.
• Individuals with a gastrostomy.
• Abnormalities of the oral, pharyngeal, or esophageal structures.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

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
China	Railway Commu.	Zhenzhou

Sponsors (1)

Lead Sponsor	Collaborator
Copka Sonpashan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gugging Swallowing Screen	The Gugging Swallowing Screen is used to assess dysphagia. The Screen consists of 10 items covering various aspects of swallowing, including oral and pharyngeal muscle function, oral sensation, tongue coordination, and more. The total scores range from 1 to 20, with lower scores indicating more severe dysphagia.	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
Secondary	Eating Assessment Tool-10	Subjective perception of swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10). The EAT-10 comprises 10 questions that assess various aspects of swallowing function. Each question is scored on a scale from 0 to 4, indicating the severity of swallowing difficulty, with 0 for no difficulty and 4 for severe difficulty. Participants could rate it based on the subjective perception. The total score on the EAT-10 ranges from 0 to 40, with higher scores indicating more severe swallowing disorders.	day 1 and day 21