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Not yet recruitingNCT06328244Updated Apr 11, 2024

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

An interventional study of Simple swallowing training in Dysphagia, sponsored by Copka Sonpashan. Not yet recruiting. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Copka Sonpashan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dysphagia

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03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Complicated with severe liver and kidney failure, tumors, or hematological disorders.
  • Physical disability.
  • Difficulty in mobility.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
280 participants (estimated)

Study arms

  • Experimental
    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

    Behavioral: Simple swallowing training

  • No intervention
    Blank group

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

Interventions

  • BehavioralSimple 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: day 1 and day 21

Secondary outcomes

  1. Time consumed in eating

    We require participants to eat a lunch according to their daily intake and habits, and count the time consumed

    Time frame: day 1 and day 21

  2. 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

    Time frame: day 1 and day 21

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06328244
Lead sponsor
Copka Sonpashan
Responsible party
Copka Sonpashan (The Research Director, Chao Phya Abhaibhubejhr Hospital) — Sponsor-investigator
First posted
Mar 25, 2024
Start date
Apr 2024 (estimated)
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Apr 11, 2024

Study contacts

Qianyun Ce
Contact
linchuangzhuce@163.com
15333866454
Nieto Luis
study chair · Site Coordinator of United Medical Group

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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