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NCT Number: NCT06328231

The Impact of Swallowing Intervention for Elderly Community Dwellers

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Railway Commu.

Zhenzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systematic simple swallowing training

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.

Primary outcomes

  1. Gugging Swallowing Screen

    Time frame: day 1 and day 21

    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.

Secondary outcomes

  1. Time consumed in eating

    Time frame: day 1 and day 21

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

  2. Swallowing-Related Quality of Life Questionnaire

    Time frame: day 1 and day 21

    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

  3. Eating Assessment Tool-10

    Time frame: day 1 and day 21

    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.

  4. Maximum tongue pressure

    Time frame: day 1 and day 21

    Tongue pressure instruments were used for maximum tongue pressure. The device measured the maximum pressure between the subject's tongue and the palate.

  5. Bite force

    Time frame: day 1 and day 21

    Bite force testers were used for bite force. All subjects were instructed to try their best to bite it with centric dental occlusion

  6. Masticatory ability

    Time frame: day 1 and day 21

    participants were required to chew 2g of gummy jelly relaxedly for twenty seconds. Then, 10 mL of water was used for gargling. The chewing materials were discharged to a filtering net. The glucose amount that passed the net was recorded with a glucose sensor.

Sponsors and collaborators

Lead sponsor

Copka Sonpashan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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