Community-Based Swallowing Training for Elderly Individuals: Impact and Benefits

NCT ID: NCT06328244

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-06-30

Brief 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.

Detailed 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.

Conditions

Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Systematic simple swallowing training

The elderly individuals will be arranged to undergo a continuous three-week (21 days) duration of systematic simple swallowing training, with weekends off and training conducted only on weekdays, two sessions per day, each lasting 15-30 minutes. Each training session will be conducted approximately one hour prior to meals. Apart from this,we require participants to only engage in daily activities and avoid strenuous and dangerous behaviors

Group Type: EXPERIMENTAL

Simple swallowing training

Intervention Type: BEHAVIORAL

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.

Blank group

No intervention will be applied to this group. It is a blank group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copka Sonpashan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Copka Sonpashan

The Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nieto Luis

Role: STUDY_CHAIR

Site Coordinator of United Medical Group

Central Contacts

Qianyun Ce

Role: CONTACT

linchuangzhuce@163.com

15333866454

Other Identifiers

Community-Based Swallowing

Identifier Type: -

Identifier Source: org_study_id