- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06303856
How Active Breathing Training Improves Dysphagia in Elderly People
March 11, 2024 updated by: Muhammad
How Active Breathing Training Improves Dysphagia in Elderly People: A Preliminary Self-control Study
The goal of this clinical trial is to explore the impact of Active Breathing Exercises 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 Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders.
All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays.
The training will be conducted two sessions per day, lasting 15-30 minutes each.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigators have designed a simple and user-friendly training method called "Active Breathing Exercises" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly.
The goal of this clinical trial is to explore the impact of Active Breathing Exercises 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 Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders.
All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays.
The training will be conducted two sessions per day, lasting 15-30 minutes each.
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lavie Ce, Master
- Phone Number: 15333828388
- Email: 17695841016@163.com
Study Locations
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Bangkok, Thailand
- Thai-Z Uni Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Breathing Exercises
The observation group is the only group of the participants.The elderly individuals will be arranged to undergo a continuous three-week (21 days) duration of Active Breathing Exercises, with weekends off and training conducted only on weekdays.
Apart from this,we require participants to only engage in daily activities and avoid strenuous and dangerous behaviors.
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Active breathing exercises aim to enhance the strength and flexibility of respiratory muscles through a series of exercises, improving breathing patterns and increasing respiratory efficiency.
The following are common components of active breathing exercises: 1) Deep Breathing.
2) Chest Expansion.
3) Diaphragmatic Breathing.
4) Coughing Techniques.
5) Expiratory Resistance Training.
6) Gradual Increase in Activity.
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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
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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.
The scale ranges 0 - 40.
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day 1 and day 21
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time consumed in eating
Time Frame: day 1 and day 21
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We require participants to eat a lunch according to their daily intake and habits, and count the time consumed
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day 1 and day 21
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Swallowing-Related Quality of Life Questionnaire
Time Frame: day 1 and day 21
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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, ranging 0 - 100.
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day 1 and day 21
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Nieto Luis, Master, Site Coordinator of United Medical Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
March 5, 2024
First Submitted That Met QC Criteria
March 5, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABE-OLDer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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