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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT06232031
Other study ID # 2024-KY-0120
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 25, 2024
Est. completion date February 28, 2024

Study information

Verified date March 2024
Source People's Hospital of Zhengzhou University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 28, 2024
Est. primary completion date February 25, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Active Breathing Exercises
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zeng Changhao

Outcome

Type Measure Description Time frame Safety issue
Primary 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. day 1 and day 21
Secondary Time consumed in eating We require participants to eat a lunch according to their daily intake and habits, and count the time consumed day 1 and day 21
Secondary Water Swallow Test The Water Swallow Test was recruited to assess swallowing function in participants at admission. Specifically, participants were instructed to sit and drink 30 ml of warm water. A 5-point scoring system is used as follows:
Point: Successful swallowing of water within 5 seconds without coughing.
Points: Able to swallow the water once but taking more than 5 seconds or swallowing in two or more attempts without coughing.
Points: Able to swallow the water once with coughing.
Points: Able to swallow the water in two or more attempts with coughing.
Points: Unable to swallow all of the water, frequent coughing. The higher points indicate the worse swallowing function
day 1 and day 21
Secondary 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 day 1 and day 21
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