The Impact of Swallowing Intervention for Elderly Community Dwellers
The Effect of Simple Swallowing Rehabilitation Training for Elderly Community Dwellers: A Preliminary Study
1 other identifier
interventional
248
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedStudy Start
First participant enrolled
March 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2024
CompletedJuly 9, 2024
July 1, 2024
20 days
March 10, 2024
July 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Time consumed in eating
day 1 and day 21
Swallowing-Related Quality of Life Questionnaire
day 1 and day 21
Eating Assessment Tool-10
day 1 and day 21
Maximum tongue pressure
day 1 and day 21
Bite force
day 1 and day 21
- +1 more secondary outcomes
Study Arms (2)
Systematic simple swallowing training
EXPERIMENTALThe 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 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
Blank Group
NO INTERVENTIONThis group received no intervention but were requested to do mild physical activities by themselves
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Copka Sonpashanlead
Study Sites (1)
Railway Commu.
Zhenzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nieto Luis
Site Coordinator of United Medical Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- The Research Director
Study Record Dates
First Submitted
March 10, 2024
First Posted
March 25, 2024
Study Start
March 25, 2024
Primary Completion
April 14, 2024
Study Completion
April 14, 2024
Last Updated
July 9, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share