DysphagiaEFFORT-PDNCT07773025
Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With PD
A study testing Effortful swallow in people with Dysphagia and Parkinson Disease (PD), run by University of Alberta.
Trial summary
The goal of this clinical trial is to learn whether a 4-week effortful swallow exercise program helps adults with Parkinson disease who have swallowing problems. The effortful swallow is a swallowing exercise where a person swallows with extra effort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Parkinson Disease (PD)
- What is being tested?
- Effortful swallow
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Aug 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Neurologist-confirmed diagnosis of Parkinson disease
- Self-report of one or more swallowing symptoms, such as difficulty managing secretions, coughing during meals, choking on food, or respiratory infection other than COVID-19 in the past 6 months
- Baseline videofluoroscopic swallowing assessment showing prolonged time to laryngeal vestibule closure and/or poor pharyngeal area at maximum constriction on regular-effort swallows with thin or mildly thick liquid stimuli, relative to healthy reference values
Who cannot join
- History of head and neck cancer
- History of radical neck dissection, anterior cervical spine surgery, or neck/oropharyngeal surgery, except tonsillectomy or adenoidectomy
- History of any neurological disease other than Parkinson disease
- Cognitive or receptive communication difficulties that preclude the ability to follow English-language study instructions
- History of brain surgery, including deep brain stimulation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: EFFORT-PD: Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease
The goal of this clinical trial is to learn whether a 4-week effortful swallow exercise program helps adults with Parkinson disease who have swallowing problems. The effortful swallow is a swallowing exercise where a person swallows with extra effort.
Researchers will compare adults who start the exercise program right away with adults who start the program after a 4-week waiting period. All participants who remain eligible will have the opportunity to receive the exercise program.
Participants will have swallowing assessments, including video X-ray swallowing tests called videofluoroscopy. They will also complete questionnaires and take part in a remotely supervised swallowing exercise program with a speech-language pathologist. Participants who remain eligible and take part in the exercise program will use a tongue pressure device during practice. The main study period lasts about 10 weeks. Participants will also complete brief follow-up questionnaires at 6 months and 12 months.
Read the detailed description
This is a single-centre, randomized delayed-intervention study of a structured effortful swallow exercise program for adults with Parkinson disease and dysphagia. The effortful swallow is a swallowing exercise in which a person swallows with extra effort. The study is designed to evaluate whether a 4-week remotely supervised effortful swallow program can improve swallowing function.
Participants who remain eligible after baseline assessment will be randomly assigned to start the intervention right away or after a 4-week waiting period. This delayed-intervention design allows all eligible participants to receive the exercise program while also allowing researchers to compare swallowing outcomes between groups during the first 4 weeks.
The intervention will be delivered remotely by a speech-language pathologist. Participants will practise effortful swallow exercises at home and will use a tongue pressure device during practice to support measurement and feedback. Swallowing function will be assessed using videofluoroscopy, which is a video X-ray swallowing test. Participants will also complete questionnaires about swallowing and related health outcomes during the study and follow-up period.
- Conditions
- Dysphagia, Parkinson Disease (PD)
- Being tested
- Effortful swallow
- Keywords
- Dysphagia, Parkinson disease, effortful swallow
- Medical subject headings
- Deglutition Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effortful swallowBehavioural
A 4-week remotely supervised swallowing exercise program delivered by a speech-language pathologist. Participants will practise effortful swallows at home using saliva and mildly thick liquids, according to study instructions. Participants will use a tongue pressure device during practice to support measurement and feedback. Participants may also complete home practice logs.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Participants assigned to this arm will begin the 4-week effortful swallow exercise program after baseline assessment. The program is delivered remotely by a speech-language pathologist. Participants will practise swallowing exercises at home and will use a tongue pressure device during practice. Participants will complete swallowing assessments and questionnaires during the study and follow-up period. Receives: Behavioral: Effortful swallow |
| Delayed Intervention | Other | Participants assigned to this arm will wait about 4 weeks before beginning the 4-week effortful swallow exercise program. During the waiting period, participants will continue usual clinical care as recommended by their health care team. After the waiting period, participants will receive the same remotely delivered effortful swallow exercise program as the immediate intervention group, including use of a tongue pressure device during practice. Receives: Behavioral: Effortful swallow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Improved Swallowing Function at Week 5
Improved swallowing function will be defined using videofluoroscopic swallowing study findings. Participants will be classified as improved if they show improvement in Penetration-Aspiration Scale score and/or reduced pharyngeal residue at Week 5 compared with baseline. The primary comparison will be between the immediate intervention group and the delayed-intervention group at Week 5, before the delayed-intervention group begins the exercise program.
Measured: Baseline to Week 5
Secondary outcomes (2)
Proportion of Participants With Improved Swallowing Function or Physiology at Week 10
Participants will be classified as improved if they show one or both of the following at Week 10 compared with baseline: shorter time to laryngeal vestibule closure in association with improvement in Penetration-Aspiration Scale score; and/or improved pharyngeal constriction in association with reduced pharyngeal residue. Pharyngeal constriction and residue will be measured from videofluoroscopy using pixel-based tracing normalized to cervical spine length.
Measured: Baseline to Week 10
Change in Munich Dysphagia Test-Parkinson Disease Score
Participant-reported swallowing symptoms will be measured using the Munich Dysphagia Test-Parkinson Disease questionnaire. Lower overall scores indicate improvement. Change from baseline will be assessed at Week 5, Week 10, 6 months, and 12 months.
Measured: Baseline to Week 5, Week 10, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2030 (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.
- More trials run by University of AlbertaThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pooja Gandhi, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773025
- Sponsor's protocol ID
- Pro00168314
- Acronym
- EFFORT-PD
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Results will be reported in aggregate form. The study includes sensitive clinical and videofluoroscopy-derived data, and the current consent and ethics approval do not include a plan for sharing de-identified individual participant data outside the approved study team.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFORT-PD: Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease
- ClinicalTrials.gov ID
- NCT07773025
- Acronym / sponsor ID
- EFFORT-PD / Pro00168314
- Conditions
- Dysphagia, Parkinson Disease (PD)
- Keywords
- Dysphagia, Parkinson disease, effortful swallow
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 19 Aug 2026 (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 learn whether a 4-week effortful swallow exercise program helps adults with Parkinson disease who have swallowing problems. The effortful swallow is a swallowing exercise where a person swallows with extra effort.
Researchers will compare adults who start the exercise program right away with adults who start the program after a 4-week waiting period. All participants who remain eligible will have the opportunity to receive the exercise program.
Participants will have swallowing assessments, including video X-ray swallowing tests called videofluoroscopy. They will also complete questionnaires and take part in a remotely supervised swallowing exercise program with a speech-language pathologist. Participants who remain eligible and take part in the exercise program will use a tongue pressure device during practice. The main study period lasts about 10 weeks. Participants will also complete brief follow-up questionnaires at 6 months and 12 months.
Detailed description
This is a single-centre, randomized delayed-intervention study of a structured effortful swallow exercise program for adults with Parkinson disease and dysphagia. The effortful swallow is a swallowing exercise in which a person swallows with extra effort. The study is designed to evaluate whether a 4-week remotely supervised effortful swallow program can improve swallowing function.
Participants who remain eligible after baseline assessment will be randomly assigned to start the intervention right away or after a 4-week waiting period. This delayed-intervention design allows all eligible participants to receive the exercise program while also allowing researchers to compare swallowing outcomes between groups during the first 4 weeks.
The intervention will be delivered remotely by a speech-language pathologist. Participants will practise effortful swallow exercises at home and will use a tongue pressure device during practice to support measurement and feedback. Swallowing function will be assessed using videofluoroscopy, which is a video X-ray swallowing test. Participants will also complete questionnaires about swallowing and related health outcomes during the study and follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Effortful swallowParticipants assigned to this arm will begin the 4-week effortful swallow exercise program after baseline assessment. The program is delivered remotely by a speech-language pathologist. Participants will practise swallowing exercises at home and will use a tongue pressure device during practice. Participants will complete swallowing assessments and questionnaires during the study and follow-up period. |
| Delayed Intervention | Other | Behavioral: Effortful swallowParticipants assigned to this arm will wait about 4 weeks before beginning the 4-week effortful swallow exercise program. During the waiting period, participants will continue usual clinical care as recommended by their health care team. After the waiting period, participants will receive the same remotely delivered effortful swallow exercise program as the immediate intervention group, including use of a tongue pressure device during practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Neurologist-confirmed diagnosis of Parkinson disease
- Self-report of one or more swallowing symptoms, such as difficulty managing secretions, coughing during meals, choking on food, or respiratory infection other than COVID-19 in the past 6 months
- Baseline videofluoroscopic swallowing assessment showing prolonged time to laryngeal vestibule closure and/or poor pharyngeal area at maximum constriction on regular-effort swallows with thin or mildly thick liquid stimuli, relative to healthy reference values
Key exclusion criteria (5 listed)
- History of head and neck cancer
- History of radical neck dissection, anterior cervical spine surgery, or neck/oropharyngeal surgery, except tonsillectomy or adenoidectomy
- History of any neurological disease other than Parkinson disease
- Cognitive or receptive communication difficulties that preclude the ability to follow English-language study instructions
- History of brain surgery, including deep brain stimulation
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 |
|---|---|---|
| Effortful swallowA 4-week remotely supervised swallowing exercise program delivered by a speech-language pathologist. Participants will practise effortful swallows at home using saliva and mildly thick liquids, according to study instructions. Participants will use a tongue pressure device during practice to support measurement and feedback. Participants may also complete home practice logs. | Behavioural | Delayed Intervention, Immediate Intervention |
Primary outcome
Proportion of Participants With Improved Swallowing Function at Week 5
Time frame: Baseline to Week 5
Improved swallowing function will be defined using videofluoroscopic swallowing study findings. Participants will be classified as improved if they show improvement in Penetration-Aspiration Scale score and/or reduced pharyngeal residue at Week 5 compared with baseline. The primary comparison will be between the immediate intervention group and the delayed-intervention group at Week 5, before the delayed-intervention group begins the exercise program.
2 secondary outcomes
Proportion of Participants With Improved Swallowing Function or Physiology at Week 10
Time frame: Baseline to Week 10
Change in Munich Dysphagia Test-Parkinson Disease Score
Time frame: Baseline to Week 5, Week 10, 6 months, and 12 months
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 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Results will be reported in aggregate form. The study includes sensitive clinical and videofluoroscopy-derived data, and the current consent and ethics approval do not include a plan for sharing de-identified individual participant data outside the approved study team.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Effortful swallow in people with Dysphagia and Parkinson Disease (PD), run by University of Alberta.
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 4 inclusion and 5 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 19 Aug 2026. 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?
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 Pooja Gandhi, PhD, R.SLP, SLP(C) (7804920596, pooja.gandhi@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Improved Swallowing Function at Week 5 (time frame: Baseline to Week 5). 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 19 Aug 2026.