DysphagiaNCT06256874
Effect of Myofascial Release on Dysphagia Prevention for Elderly People in the Community
A study testing Myofascial Release Training in people with Dysphagia, run by Zeng Changhao at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Myofascial Release Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesTaiwan
- Study dates
- 29 Feb 2024to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- Physical disability.
- Difficulty in mobility.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Gaoxiong Rehabilitation Hospital
Xinzhu
Sumei Wang, Doctor
- Recruiting
Hsinchu Rehabilitation Hospital
Xinzhu
Haim Liu, Master
About this study
Official title: Effect of Myofascial Release on Dysphagia Prevention for Elderly People in the Community: A Preliminary Self-control Study
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.
Read the detailed 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.
- Conditions
- Dysphagia
- Being tested
- Myofascial Release Training
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Release TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the observation group | Experimental | 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 Myofascial Release 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 Receives: Behavioral: Myofascial Release Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1 and day 21
Secondary outcomes (3)
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
Measured: day 1 and day 21
Time consumed in eating
We require participants to eat a lunch according to their daily intake and habits, and count the time consumed
Measured: day 1 and day 21
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.
Measured: day 1 and day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start29 Feb 2024
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Study chair, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256874
- Sponsor's protocol ID
- Jinmo-old
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofascial Release on Dysphagia Prevention for Elderly People in the Community: A Preliminary Self-control Study
- ClinicalTrials.gov ID
- NCT06256874
- Acronym / sponsor ID
- Jinmo-old
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the observation group | Experimental | Behavioral: Myofascial Release TrainingThe 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 Myofascial Release 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- Physical disability.
- Difficulty in mobility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial Release TrainingMyofascial 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. | Behavioural | the observation group |
Primary outcome
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
3 secondary outcomes
Water Swallow Test
Time frame: day 1 and day 21
Time consumed in eating
Time frame: day 1 and day 21
Functional Oral Intake Scale
Time frame: day 1 and day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Master study chair
Site Coordinator of United Medical Group located in Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Release Training in people with Dysphagia, run by Zeng Changhao at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongji Zeng, Master (17695841016, 535226944@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing-Related Quality of Life Questionnaire (time frame: day 1 and day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.