DysphagiaNCT06393283
The Impact of Diaphragm Training on Dysphagia in Elderly Nursing Home Residents
A study testing Diaphragm Training in people with Dysphagia, run by Copka Sonpashan.
Trial summary
The goal of this clinical trial is to explore the Diaphragm Training on swallowing function in Elderly Nursing Home Residents (≥60 year old) with swallowing disorders. It primarily aims to address: the effects of Diaphragm Training on swallowing function and quality of life in Elderly Nursing Home Residents. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Diaphragm Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Jun 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.
- early dysphagia caused by sarcopenia.
Who cannot join
- Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- Physical disability.
- Difficulty in mobility.
- Simultaneously receiving other therapies that might influence this study.
- Individuals with a gastrostomy.
- Abnormalities of the oral, pharyngeal, or esophageal structures.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Diaphragm Training on Dysphagia in Elderly Nursing Home Residents: A Preliminary Study
The goal of this clinical trial is to explore the Diaphragm Training on swallowing function in Elderly Nursing Home Residents (≥60 year old) with swallowing disorders. It primarily aims to address: the effects of Diaphragm Training on swallowing function and quality of life in Elderly Nursing Home Residents. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) Diaphragm Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.
Read the detailed description
Diaphragm training for dysphagia in elderly nursing home residents involves exercises and techniques aimed at strengthening the diaphragm muscle to improve swallowing function. Dysphagia, or difficulty swallowing, is common among older adults and can lead to complications such as malnutrition, dehydration, and aspiration pneumonia. Diaphragm training may include breathing exercises, postural adjustments, and swallowing maneuvers designed to enhance coordination and strength in the muscles involved in the swallowing process. By targeting the diaphragm, which plays a crucial role in breathing and swallowing coordination, this training approach aims to alleviate dysphagia symptoms and improve overall swallowing function in elderly nursing home residents, thus enhancing their quality of life and reducing the risk of associated health complications.
The goal of this clinical trial is to explore the Diaphragm Training on swallowing function in Elderly Nursing Home Residents (≥60 year old) with swallowing disorders. It primarily aims to address: the effects of Diaphragm Training on swallowing function and quality of life in Elderly Nursing Home Residents. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) Diaphragm Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.
- Conditions
- Dysphagia
- Being tested
- Diaphragm 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.
Diaphragm TrainingBehavioural
Diaphragm training includes both active and passive methods. Passive training involves placing weights on the participant's abdomen to provide resistance during breathing. Active training involves instructing participants to practice diaphragmatic breathing techniques.
| Study group | Role | What they receive |
|---|---|---|
| the intervention group | Experimental | Diaphragm Training will be given twice a day and 30min per time. Receives: Behavioral: Diaphragm Training |
| the blank group | No intervention | No intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gugging Swallowing Screen
The Gugging Swallowing Screen is used to assess dysphagia. The Screen consists of 10 items covering various aspects of swallowing, including oral and pharyngeal muscle function, oral sensation, tongue coordination, and more. The total scores range from 1 to 20, with lower scores indicating more severe dysphagia.
Measured: day 1 and day 21
Secondary outcomes (4)
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
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
Dysphagia Handicap Index
Dysphagia Handicap Index is a self-reported questionnaire used to assess the impact of dysphagia on an individual's quality of life. It typically consists of multiple questions related to the physical, functional, and emotional aspects of swallowing difficulties. The total score range varies between 0 and 100. A higher score indicates a greater perceived impact of dysphagia on the individual's quality of life.
Measured: day 1 and day 21
Eating Assessment Tool-10
Subjective perception of swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10). The EAT-10 comprises 10 questions that assess various aspects of swallowing function. Each question is scored on a scale from 0 to 4, indicating the severity of swallowing difficulty, with 0 for no difficulty and 4 for severe difficulty. Participants could rate it based on the subjective perception. The total score on the EAT-10 ranges from 0 to 40, with higher scores indicating more severe swallowing disorders.
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 posted1 May 2024
- Study startApr 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copka Sonpashan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Copka Sonpashan, Chao Phya Abhaibhubejhr Hospital
- Investigators
- Louis Wi, Study chair, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393283
- Sponsor's protocol ID
- GejiYanglaoyuan
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Diaphragm Training on Dysphagia in Elderly Nursing Home Residents: A Preliminary Study
- ClinicalTrials.gov ID
- NCT06393283
- Acronym / sponsor ID
- GejiYanglaoyuan
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copka SonpashanOther government
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 1 May 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 Diaphragm Training on swallowing function in Elderly Nursing Home Residents (≥60 year old) with swallowing disorders. It primarily aims to address: the effects of Diaphragm Training on swallowing function and quality of life in Elderly Nursing Home Residents. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) Diaphragm Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.
Detailed description
Diaphragm training for dysphagia in elderly nursing home residents involves exercises and techniques aimed at strengthening the diaphragm muscle to improve swallowing function. Dysphagia, or difficulty swallowing, is common among older adults and can lead to complications such as malnutrition, dehydration, and aspiration pneumonia. Diaphragm training may include breathing exercises, postural adjustments, and swallowing maneuvers designed to enhance coordination and strength in the muscles involved in the swallowing process. By targeting the diaphragm, which plays a crucial role in breathing and swallowing coordination, this training approach aims to alleviate dysphagia symptoms and improve overall swallowing function in elderly nursing home residents, thus enhancing their quality of life and reducing the risk of associated health complications.
The goal of this clinical trial is to explore the Diaphragm Training on swallowing function in Elderly Nursing Home Residents (≥60 year old) with swallowing disorders. It primarily aims to address: the effects of Diaphragm Training on swallowing function and quality of life in Elderly Nursing Home Residents. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) Diaphragm Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Experimental | Behavioral: Diaphragm TrainingDiaphragm Training will be given twice a day and 30min per time. |
| the blank group | No intervention | –No intervention will be applied. |
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.
- early dysphagia caused by sarcopenia.
Key exclusion criteria (6 listed)
- Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- Physical disability.
- Difficulty in mobility.
- Simultaneously receiving other therapies that might influence this study.
- Individuals with a gastrostomy.
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 |
|---|---|---|
| Diaphragm TrainingDiaphragm training includes both active and passive methods. Passive training involves placing weights on the participant's abdomen to provide resistance during breathing. Active training involves instructing participants to practice diaphragmatic breathing techniques. | Behavioural | the intervention group |
Primary outcome
Gugging Swallowing Screen
Time frame: day 1 and day 21
The Gugging Swallowing Screen is used to assess dysphagia. The Screen consists of 10 items covering various aspects of swallowing, including oral and pharyngeal muscle function, oral sensation, tongue coordination, and more. The total scores range from 1 to 20, with lower scores indicating more severe dysphagia.
4 secondary outcomes
Time consumed in eating
Time frame: day 1 and day 21
Swallowing-Related Quality of Life Questionnaire
Time frame: day 1 and day 21
Dysphagia Handicap Index
Time frame: day 1 and day 21
Eating Assessment Tool-10
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 1 May 2024.
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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.
Louis Wi study chair
Site Coordinator of United Medical Group
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm Training in people with Dysphagia, run by Copka Sonpashan.
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 6 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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Laviena Ce (15422548954, byyx0517@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gugging Swallowing Screen (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 1 May 2024.