- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06328244
Community-Based Swallowing Training for Elderly Individuals: Impact and Benefits
A Preliminary Self-control Study to Explore the Effect of Community-Based Swallowing Training for Elderly Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Qianyun Ce
- Phone Number: 15333866454
- Email: linchuangzhuce@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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. |
No Intervention: Blank group
No intervention will be applied to this group.
It is a blank group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Assessment Tool-10
Time Frame: day 1 and day 21
|
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.
|
day 1 and day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
day 1 and day 21
|
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
|
day 1 and day 21
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nieto Luis, Site Coordinator of United Medical Group
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Community-Based Swallowing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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