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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06256874
Other study ID # Jinmo-old
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 29, 2024
Est. completion date March 2024

Study information

Verified date March 2024
Source People's Hospital of Zhengzhou University
Contact Hongji Zeng, Master
Phone 17695841016
Email 535226944@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore the impact of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address the effects of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) Myofascial Release Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.


Description:

Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. The goal of this clinical trial is to explore the impact of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address the effects of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) Myofascial Release Training, 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 Recruiting
Enrollment 300
Est. completion date March 2024
Est. primary completion date March 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. - Dysphagia 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:
Myofascial Release Training
Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. Myofascial release therapy is commonly used to treat muscle spasms, chronic pain, skeletal and joint issues, among others.

Locations

Country Name City State
Taiwan Gaoxiong Rehabilitation Hospital Xinzhu
Taiwan Hsinchu Rehabilitation Hospital Xinzhu

Sponsors (1)

Lead Sponsor Collaborator
Zeng Changhao

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Water Swallow Test The Water Swallow Test was recruited to assess swallowing function in patients at admission. Specifically, patients 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 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 Functional Oral Intake Scale During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted. day 1 and day 21
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