External Pharyngeal Exerciser for Dysphagia

Overseen By Associate Professor of Medicine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Carotid disorders, Muscle diseases, Neuro-muscular disorders, Esophageal symptoms, Autonomic dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

30 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment External Pharyngeal Exerciser?

Research shows that exercises targeting the throat and swallowing muscles, like the modified jaw opening exercise and chin tuck against resistance, can improve swallowing function in people with swallowing difficulties, such as those recovering from a stroke or with oropharyngeal dysphagia. ^{1 2 3 4 5}

Is the External Pharyngeal Exerciser generally safe for humans?

Research on exercise interventions, including those for older or chronically ill adults, shows that serious adverse events are rare, with most issues being minor, like muscle injuries. Safety can be improved by starting with low intensity and gradually increasing it. ^{6 7 8 9 10}

How does this treatment for dysphagia differ from other treatments?

This treatment involves specific exercises like jaw-retraction and modified jaw-opening exercises, which are designed to improve swallowing by strengthening muscles involved in the process. Unlike other treatments that might focus on dietary changes or medication, these exercises target muscle function directly to enhance swallowing efficiency. ^{5 11 12 13 14}

What is the purpose of this trial?

This trial is testing a new device called the External Pharyngeal Exerciser (EPE) to help people who have trouble swallowing due to conditions like stroke, Parkinson's disease, or head/neck cancer treatments. The device aims to strengthen throat muscles by providing resistance during swallowing exercises. The study will check if the device is safe, if patients are willing to use it, and if it works better than current treatments.

Eligibility Criteria

Inclusion Criteria

Pharyngeal dysphagia secondary to central neurological disorder such as Parkinson's disease or stroke

Pharyngeal dysphagia head/neck cancer secondary to surgery/radiation

Pharyngeal dysphagia secondary to elderly age > 65

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the External Pharyngeal Exerciser (EPE) along with standard swallow therapy to assess feasibility, safety, and efficacy

1 year

Evaluations every two weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• External Pharyngeal Exerciser

Participant Groups

Group I: exerciser and standard therapy Experimental Treatment 1 Intervention

exerciser and standard therapy

Group II: standard therapy Active Control 1 Intervention

standard therapy

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Findings from Research

In a study involving 9 patients with dysphagia after stroke, a self-exercise program that included effortful swallowing and tongue strengthening significantly improved swallowing function as measured by the videofluoroscopic dysphagia scale.

The intervention was conducted 5 times a week for 4 weeks, showing that regular self-exercise can be an effective method to enhance oropharyngeal swallowing in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of bedside self-exercise on oropharyngeal swallowing function in stroke patients with dysphagia: a pilot study. Cho, YS., Oh, DH., Paik, YR., et al.[2020]

The modified jaw opening exercise (MJOE) was found to be safe and feasible for post-stroke patients with dysphagia, with no reported pain during the exercise regimen.

After six weeks of MJOE, participants showed significant improvements in hyoid displacement during swallowing, indicating its effectiveness in enhancing swallowing function compared to a control exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposal for a Modified Jaw Opening Exercise for Dysphagia: A Randomized, Controlled Trial. Koyama, Y., Sugimoto, A., Hamano, T., et al.[2017]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A systematic review of 773 studies involving over 38,000 participants found that exercise therapy does not increase the risk of serious adverse events, indicating it is a safe intervention.

However, exercise therapy was associated with a higher risk of non-serious adverse events, with a relative risk of 1.19, meaning that for every 6 participants, one additional non-serious adverse event may occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Niemeijer, A., Lund, H., Stafne, SN., et al.[2022]

In a pilot study involving 549 herbalists in the UK, 194 patients reported on their experiences with Chinese herbal medicine, with 14% experiencing adverse events such as diarrhea, fatigue, and nausea, but no serious adverse events were noted.

First-time patients were more likely to report adverse events compared to those who had previously consulted herbalists, indicating that prior experience may reduce the likelihood of experiencing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Chinese herbal medicine: a pilot study for a national survey. MacPherson, H., Liu, B.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors. [2022]

2. Sweden pubmed.ncbi.nlm.nih.gov

Effects of mechanical inspiration and expiration exercise on velopharyngeal incompetence in subacute stroke patients. [2019]

3. Japan pubmed.ncbi.nlm.nih.gov

Effects of bedside self-exercise on oropharyngeal swallowing function in stroke patients with dysphagia: a pilot study. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Chin Tuck against Resistance Exercise in Citizens with Oropharyngeal Dysphagia-A Randomised Controlled Study. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Proposal for a Modified Jaw Opening Exercise for Dysphagia: A Randomized, Controlled Trial. [2017]

6. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The safety of Chinese herbal medicine: a pilot study for a national survey. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Jaw-retraction exercise increases anterior hyoid excursion during swallowing in older adults with mild dysphagia. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Effect of Modified Shaker Exercise on the Amplitude and Duration of Swallowing Sounds: Evidence from Cervical Auscultation. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Jaw-opening exercise for insufficient opening of upper esophageal sphincter. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

The impact of daytime transoral neuromuscular stimulation on upper airway physiology - A mechanistic clinical investigation. [2022]