Oropharyngeal DysphagiaNCT07049471
The Effect of Swallowing Exercise and Maneuver Program For Older Adults With Dysphagia in Nursing Home
A study testing Swallowing Exercise and Maneuver Program for Older Adults with Dysphagia in people with Oropharyngeal Dysphagia and Swallowing Disorders, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This clinical trial aimed to evaluate the effectiveness of a structured swallowing exercise and maneuver program for older adults with dysphagia living in a nursing home. Dysphagia, or difficulty in swallowing, is common in elderly populations and may lead to malnutrition, dehydration, and aspiration pneumonia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia, Swallowing Disorders, Frailty-related Dysphagia
- What is being tested?
- Swallowing Exercise and Maneuver Program for Older Adults with Dysphagia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Jul 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- aged 60 years or older
- experiencing swallowing difficulties as assessed by the Eating Assessment Tool-10 (EAT-10)
- having no history of neurological disease
- possessing adequate communication abilities
- and being capable of performing daily activities either independently or with partial assistance
Who cannot join
- individuals with dermatological conditions in the anterior neck region, hypertension, orofacial pain such as trigeminal neuropathy or toothache, as well as those with significant malocclusion or facial asymmetry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Faculty of Nursing Universitas Indonesia
Depok, West Java, 16424
About this study
This clinical trial aimed to evaluate the effectiveness of a structured swallowing exercise and maneuver program for older adults with dysphagia living in a nursing home. Dysphagia, or difficulty in swallowing, is common in elderly populations and may lead to malnutrition, dehydration, and aspiration pneumonia.
In this study, 72 participants aged 60 years and older were randomly assigned to either an intervention group or a control group. The intervention group received a combined swallowing exercise and maneuver program-including Masako Maneuver, Chin Tuck Against Resistance, Supraglottic Swallow, and Super-Supraglottic Swallow-performed three times daily before meals over a six-week period. The control group received standard care, including upright sitting posture during meals.
Swallowing ability was measured using the EAT-10 questionnaire. The intervention group showed significant improvement in swallowing scores, while no meaningful changes were observed in the control group. This study suggests that nurse-led swallowing exercises can be a safe, simple, and effective strategy to improve swallowing function and quality of life in older adults living in long-term care settings.
Read the detailed description
Oropharyngeal dysphagia is a prevalent condition among older adults, particularly in institutionalized settings such as nursing homes. It is often underdiagnosed, misattributed to normal aging, and leads to serious complications including aspiration pneumonia, malnutrition, dehydration, and diminished quality of life. Despite its high burden, non-pharmacological interventions tailored to this population in Indonesia remain limited.
This randomized controlled trial was designed to assess the effectiveness of a structured swallowing exercise and maneuver program for older adults with dysphagia in a long-term care facility. The intervention integrated both pharyngeal element-based exercises (Masako Maneuver and Chin Tuck Against Resistance) and behavioral-based exercises (Supraglottic Swallow and Super-Supraglottic Swallow). These exercises were delivered as a video-guided program and administered three times per day before meals over six weeks by trained nursing staff.
Participants were randomly assigned to intervention and control groups using a simple random sampling method. The control group received standard care without swallowing exercises. Outcomes were measured using the Eating Assessment Tool-10 (EAT-10), a validated instrument for identifying clinically significant swallowing problems.
This study aimed to provide empirical evidence for the use of structured, nurse-delivered swallowing training as an effective and feasible approach to managing dysphagia among the elderly in nursing homes. It also explored the potential for routine implementation and integration into geriatric nursing practice across similar institutional care settings.
- Being tested
- Swallowing Exercise and Maneuver Program for Older Adults with Dysphagia
- Keywords
- Oropharyngeal Dysphagia, older adult, nursing home, swallowing
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing Exercise and Maneuver Program for Older Adults with DysphagiaBehavioural
The intervention is a structured swallowing exercise and maneuver program designed specifically for older adults with oropharyngeal dysphagia in nursing homes. It combines four evidence-based techniques: Masako Maneuver, Chin Tuck Against Resistance (CTAR), Supraglottic Swallow, and Super-Supraglottic Swallow. The program was delivered by nurses using video-guided instructions and was conducted three times daily before meals for six weeks. Unlike interventions targeting post-stroke dysphagia, this program focuses on non-stroke-related swallowing difficulties in frail elderly populations residing in long-term care facilities.
| Study group | Role | What they receive |
|---|---|---|
| Swallowing Exercise and Maneuver Group | Experimental | Participants in this arm received a structured swallowing exercise and maneuver program consisting of four techniques: Masako Maneuver, Chin Tuck Against Resistance (CTAR), Supraglottic Swallow, and Super-Supraglottic Swallow. The exercises were administered by nurses using a video-guided protocol, three times daily before meals for six weeks. The program was designed to improve pharyngeal muscle strength and enhance airway protection during swallowing. Receives: Behavioral: Swallowing Exercise and Maneuver Program for Older Adults with Dysphagia |
| Standard Care Group | No intervention | Participants in this arm received standard care for dysphagia, which involved upright sitting positioning during meals without any structured swallowing exercises or maneuvers. No additional behavioral interventions were provided during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Swallowing Function Measured by EAT-10 Score
Swallowing function is assessed using the Eating Assessment Tool-10 (EAT-10), a validated 10-item self-report questionnaire for identifying symptoms of dysphagia. Each item is scored from 0 (no problem) to 4 (severe problem), with a total possible score ranging from 0 to 40. A score of 3 or more indicates clinically significant dysphagia. The primary outcome is the change in EAT-10 scores from baseline (prior to intervention) to the end of the 6-week intervention period. A decrease in score reflects improvement in swallowing function.
Measured: Baseline (Day 0) and Week 6 (Post-intervention)
Change in Swallowing Function as Measured by EAT-10 Score
Swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10), a validated 10-item questionnaire designed to identify symptoms of dysphagia. Each item is scored on a 5-point Likert scale (0-4), with total scores ranging from 0 to 40. A score ≥3 indicates clinically significant swallowing difficulty. The primary outcome is the change in total EAT-10 score from baseline (pre-intervention) to the end of the 6-week intervention period. A greater reduction in the EAT-10 score indicates an improvement in swallowing function.
Measured: Baseline and 6 weeks after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Model description
- This study used a randomized, parallel-group design involving two arms: an intervention group receiving a structured swallowing exercise and maneuver program, and a control group receiving standard care. Participants were randomly assigned using a simple random sampling technique. The intervention was administered three times daily for six weeks. Outcomes were compared between groups to evaluate the effectiveness of the intervention on swallowing function in older adults with oropharyngeal dysphagia living in a nursing home.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Direktorat Riset dan Pengabdian Masyarakat Universitas Indonesia
- Responsible party
- Principal investigator, Etty Rekawati, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049471
- Sponsor's protocol ID
- NKB-215/UN2.RST/HKP.05.00/2024
- Other IDs
- NKB-215/UN2.RST/HKP.05.00/2024
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) will be shared upon reasonable request for academic or scientific purposes.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Swallowing Exercise and Maneuver Program For Older Adults With Dysphagia in Nursing Home
- ClinicalTrials.gov ID
- NCT07049471
- Acronym / sponsor ID
- NKB-215/UN2.RST/HKP.05.00/2024
- Keywords
- Oropharyngeal Dysphagia, older adult, nursing home, swallowing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Direktorat Riset dan Pengabdian Masyarakat Universitas Indonesia
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 3 Jul 2025 (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.
This clinical trial aimed to evaluate the effectiveness of a structured swallowing exercise and maneuver program for older adults with dysphagia living in a nursing home. Dysphagia, or difficulty in swallowing, is common in elderly populations and may lead to malnutrition, dehydration, and aspiration pneumonia.
In this study, 72 participants aged 60 years and older were randomly assigned to either an intervention group or a control group. The intervention group received a combined swallowing exercise and maneuver program-including Masako Maneuver, Chin Tuck Against Resistance, Supraglottic Swallow, and Super-Supraglottic Swallow-performed three times daily before meals over a six-week period. The control group received standard care, including upright sitting posture during meals.
Swallowing ability was measured using the EAT-10 questionnaire. The intervention group showed significant improvement in swallowing scores, while no meaningful changes were observed in the control group. This study suggests that nurse-led swallowing exercises can be a safe, simple, and effective strategy to improve swallowing function and quality of life in older adults living in long-term care settings.
Detailed description
Oropharyngeal dysphagia is a prevalent condition among older adults, particularly in institutionalized settings such as nursing homes. It is often underdiagnosed, misattributed to normal aging, and leads to serious complications including aspiration pneumonia, malnutrition, dehydration, and diminished quality of life. Despite its high burden, non-pharmacological interventions tailored to this population in Indonesia remain limited.
This randomized controlled trial was designed to assess the effectiveness of a structured swallowing exercise and maneuver program for older adults with dysphagia in a long-term care facility. The intervention integrated both pharyngeal element-based exercises (Masako Maneuver and Chin Tuck Against Resistance) and behavioral-based exercises (Supraglottic Swallow and Super-Supraglottic Swallow). These exercises were delivered as a video-guided program and administered three times per day before meals over six weeks by trained nursing staff.
Participants were randomly assigned to intervention and control groups using a simple random sampling method. The control group received standard care without swallowing exercises. Outcomes were measured using the Eating Assessment Tool-10 (EAT-10), a validated instrument for identifying clinically significant swallowing problems.
This study aimed to provide empirical evidence for the use of structured, nurse-delivered swallowing training as an effective and feasible approach to managing dysphagia among the elderly in nursing homes. It also explored the potential for routine implementation and integration into geriatric nursing practice across similar institutional care settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study used a randomized, parallel-group design involving two arms: an intervention group receiving a structured swallowing exercise and maneuver program, and a control group receiving standard care. Participants were randomly assigned using a simple random sampling technique. The intervention was administered three times daily for six weeks. Outcomes were compared between groups to evaluate the effectiveness of the intervention on swallowing function in older adults with oropharyngeal dysphagia living in a nursing home.
| Arm | Type | Receives |
|---|---|---|
| Swallowing Exercise and Maneuver Group | Experimental | Behavioral: Swallowing Exercise and Maneuver Program for Older Adults with DysphagiaParticipants in this arm received a structured swallowing exercise and maneuver program consisting of four techniques: Masako Maneuver, Chin Tuck Against Resistance (CTAR), Supraglottic Swallow, and Super-Supraglottic Swallow. The exercises were administered by nurses using a video-guided protocol, three times daily before meals for six weeks. The program was designed to improve pharyngeal muscle strength and enhance airway protection during swallowing. |
| Standard Care Group | No intervention | –Participants in this arm received standard care for dysphagia, which involved upright sitting positioning during meals without any structured swallowing exercises or maneuvers. No additional behavioral interventions were provided during the study period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 60 years or older
- experiencing swallowing difficulties as assessed by the Eating Assessment Tool-10 (EAT-10)
- having no history of neurological disease
- possessing adequate communication abilities
- and being capable of performing daily activities either independently or with partial assistance
Key exclusion criteria (1 listed)
- individuals with dermatological conditions in the anterior neck region, hypertension, orofacial pain such as trigeminal neuropathy or toothache, as well as those with significant malocclusion or facial asymmetry
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 |
|---|---|---|
| Swallowing Exercise and Maneuver Program for Older Adults with DysphagiaThe intervention is a structured swallowing exercise and maneuver program designed specifically for older adults with oropharyngeal dysphagia in nursing homes. It combines four evidence-based techniques: Masako Maneuver, Chin Tuck Against Resistance (CTAR), Supraglottic Swallow, and Super-Supraglottic Swallow. The program was delivered by nurses using video-guided instructions and was conducted three times daily before meals for six weeks. Unlike interventions targeting post-stroke dysphagia, this program focuses on non-stroke-related swallowing difficulties in frail elderly populations residing in long-term care facilities. | Behavioural | Swallowing Exercise and Maneuver Group |
Primary outcome
Improvement in Swallowing Function Measured by EAT-10 Score
Time frame: Baseline (Day 0) and Week 6 (Post-intervention)
Swallowing function is assessed using the Eating Assessment Tool-10 (EAT-10), a validated 10-item self-report questionnaire for identifying symptoms of dysphagia. Each item is scored from 0 (no problem) to 4 (severe problem), with a total possible score ranging from 0 to 40. A score of 3 or more indicates clinically significant dysphagia. The primary outcome is the change in EAT-10 scores from baseline (prior to intervention) to the end of the 6-week intervention period. A decrease in score reflects improvement in swallowing function.
Change in Swallowing Function as Measured by EAT-10 Score
Time frame: Baseline and 6 weeks after intervention initiation
Swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10), a validated 10-item questionnaire designed to identify symptoms of dysphagia. Each item is scored on a 5-point Likert scale (0-4), with total scores ranging from 0 to 40. A score ≥3 indicates clinically significant swallowing difficulty. The primary outcome is the change in total EAT-10 score from baseline (pre-intervention) to the end of the 6-week intervention period. A greater reduction in the EAT-10 score indicates an improvement in swallowing function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) will be shared upon reasonable request for academic or scientific purposes.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swallowing Exercise and Maneuver Program for Older Adults with Dysphagia in people with Oropharyngeal Dysphagia and Swallowing Disorders, run by Universitas Indonesia at 1 site in Indonesia.
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 1 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: opening soon, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Etty Rekawati, Doctor of Nursing (+628128506727, rekawati@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Swallowing Function Measured by EAT-10 Score (time frame: Baseline (Day 0) and Week 6 (Post-intervention)). The study lists 2 primary outcomes in all. 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 3 Jul 2025.