Pharyngeal Exerciser for Swallowing Disorders

Overseen By Mark Kern

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Neurological disorders, Muscle diseases, Esophageal symptoms, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during swallowing. Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.

Will I have to stop taking my current medications?

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

Is the Pharyngeal Exerciser safe for humans?

Studies involving devices similar to the Pharyngeal Exerciser, like the Laryngeal Restriction Device, have been conducted on healthy adults and have not reported any safety concerns. These studies focused on the effects of resistance exercises on swallowing muscles, and while they showed changes in muscle function, no adverse effects were noted. ^{1 2 3 4 5}

How is the Pharyngeal Exerciser treatment different from other treatments for swallowing disorders?

The Pharyngeal Exerciser is unique because it is an external device designed to specifically target and strengthen the muscles involved in swallowing, unlike other treatments that may focus on general exercises or oral exercises. This device offers a novel approach by providing targeted resistance to improve swallowing function. ^{2 4 6 7 8}

What data supports the effectiveness of the Pharyngeal Exerciser treatment for swallowing disorders?

Research shows that exercises like the Shaker Exercise, which is part of the Pharyngeal Exerciser treatment, can improve swallowing function in patients with swallowing difficulties. Studies have demonstrated improvements in swallowing function in stroke patients and those with head and neck cancer after performing similar exercises. ^{2 4 9 10 11}

Who Is on the Research Team?

Reza Shaker, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 18 or older who have no history of head or neck surgery, significant bleeding disorders, autonomic dysfunction, carotid vascular disorders, neuro-muscular junction disorders like myasthenia gravis, esophageal symptoms (e.g., heartburn), allergies to lidocaine and barium, severe medical conditions such as COPD or cancer, cervical spine or neurological disorders excluding Parkinson's Disease.

Exclusion Criteria

Subjects who are medically unstable.

You have a condition where your body's automatic functions, like heart rate and blood pressure, don't work properly.

Subjects with significant bleeding disorders for whom nasal intubation has been deemed contraindicated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline Assessment

Participants undergo baseline assessments including physical examination and measurement of neck and device dimensions

1 day

1 visit (in-person)

Treatment

Participants perform swallowing exercises with the pharyngeal exerciser under varying pressures, with optional videofluoroscopic examination

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Pharyngeal Exerciser

Trial Overview The study is examining the impact of a pharyngeal exerciser on swallowing pressure in both young and elderly healthy volunteers. It aims to determine whether this device can increase muscle workload during the pharyngeal phase of swallowing.

How Is the Trial Designed?

Group I: Pharyngeal exerciser group Experimental Treatment 1 Intervention

Test that application of the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing as evidenced manometrically by changes in Pharyngeal peak pressures Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral Hypopharyngeal intrabolus pressure and duration UES nadir pressure UES relaxation time Baseline UES pressure

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

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]

The Shaker Exercise is effective in improving swallowing mechanics in healthy older adults, as shown by increased hyoid and laryngeal movements after the exercise, indicating its potential benefits for those with swallowing difficulties.

While 70% of participants were able to meet the exercise goals, compliance was a challenge, with many dropouts occurring in the first two weeks, suggesting that a structured program may enhance adherence and success in achieving exercise objectives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attaining and maintaining isometric and isokinetic goals of the Shaker exercise. Easterling, C., Grande, B., Kern, M., et al.[2022]

The 8-week isometric progressive resistance oropharyngeal (I-PRO) therapy using the 5-sensor MOST device significantly improved swallowing function in a 56-year-old female stroke patient, allowing her to progress from a gastrostomy tube diet to a general oral diet and gain 15 pounds.

I-PRO therapy led to increased lingual and pharyngeal pressures, improved UES opening, and reduced swallowing residue, enhancing the patient's quality of life, although some benefits decreased during the detraining phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case study: application of isometric progressive resistance oropharyngeal therapy using the Madison Oral Strengthening Therapeutic device. Juan, J., Hind, J., Jones, C., et al.[2022]

The Shaker head-lift exercise (HLE) was tested on 52 head and neck cancer patients with dysphagia, but after 8 weeks, there were no significant improvements in objectively measured swallowing function compared to standard dysphagia management.

Despite the lack of objective improvements, patients in the HLE group reported a subjective improvement in their swallowing function, indicating a potential psychological benefit that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the Shaker head-lift exercise on swallowing function following treatment for head and neck cancer: Results from a randomized, controlled trial with videofluoroscopic evaluation. Tuomi, L., Dotevall, H., Bergquist, H., et al.[2022]

A study involving 30 healthy subjects demonstrated that applying resistance during swallowing can effectively overload and fatigue the pharyngeal muscles, which is crucial for developing rehabilitative exercises.

The results showed significant reductions in pharyngeal contractile pressure and laryngeal excursion during repeated swallowing against resistance, indicating that this method could strengthen pharyngeal muscle function safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of laryngeal restriction on pharyngeal peristalsis and biomechanics: Clinical implications. Shaker, R., Sanvanson, P., Balasubramanian, G., et al.[2019]

A novel resistance exercise program called Swallowing Against Laryngeal Restriction (SALR) significantly improved key swallowing mechanics in healthy elderly participants, including increased upper esophageal sphincter opening and laryngeal movement after 6 weeks of training.

In contrast, a sham exercise did not produce any significant changes, highlighting the efficacy of the SALR program in enhancing the pharyngeal phase of swallowing, which could lead to better swallow health maintenance in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swallow strength training exercise for elderly: A health maintenance need. Agrawal, D., Kern, M., Edeani, F., et al.[2019]

The personalized transportable folding device for seating (DATP) significantly improved hyoid bone motion during swallowing in dysphagic patients after one month of use, indicating a potential benefit for swallowing mechanics.

Despite the improvement in hyoid motion, the device did not lead to a significant enhancement in overall swallowing efficiency, suggesting that while it may aid posture and movement, further research is needed to assess its impact on swallowing quality across diverse patient conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How a personalised transportable folding device for seating impacts dysphagia. Woisard, V., Costes, M., Colineaux, H., et al.[2023]

The Madison Oral Strengthening Therapeutic (MOST) device was developed to improve tongue muscle strength and address swallowing difficulties, showing promise in both treatment and prevention of muscle atrophy.

The study compared the MOST device to the Iowa Oral Performance Instrument (IOPI) and aimed to determine the best sampling rate for measuring tongue pressure during exercises, highlighting its potential for broader use in healthy aging adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized instrument for lingual pressure measurement. Hewitt, A., Hind, J., Kays, S., et al.[2018]

A 3-month oral exercise program significantly improved tongue pressure in 66 older adults, with measurements increasing from 16.92 kPa to 20.63 kPa, indicating enhanced swallowing function.

Participants with functional tooth units showed even greater improvements in tongue pressure, suggesting that oral health may influence the effectiveness of oral exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of oral exercise on tongue pressure in Taiwanese older adults in community day care centers. Chen, HH., Lin, PY., Lin, CK., et al.[2022]

An 8-week training program with chin tuck against resistance (CTAR) and chin tuck exercise with theraband significantly improved suprahyoid muscle activation and anterior tongue pressure in 36 healthy volunteers, while Shaker exercises did not show similar benefits.

Despite improvements in muscle activation and tongue pressure, there were no significant changes in dysphagia limits across the three exercise groups, indicating that while muscle strength may improve, it does not necessarily translate to enhanced swallowing efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Different Exercise Trainings on Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit in Healthy Subjects. Kılınç, HE., Arslan, SS., Demir, N., et al.[2021]

Citations

1. Japan pubmed.ncbi.nlm.nih.gov

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

2. Japan pubmed.ncbi.nlm.nih.gov

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

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

Attaining and maintaining isometric and isokinetic goals of the Shaker exercise. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Case study: application of isometric progressive resistance oropharyngeal therapy using the Madison Oral Strengthening Therapeutic device. [2022]

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

The effect of the Shaker head-lift exercise on swallowing function following treatment for head and neck cancer: Results from a randomized, controlled trial with videofluoroscopic evaluation. [2022]

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

Effects of laryngeal restriction on pharyngeal peristalsis and biomechanics: Clinical implications. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Swallow strength training exercise for elderly: A health maintenance need. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

How a personalised transportable folding device for seating impacts dysphagia. [2023]

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

Standardized instrument for lingual pressure measurement. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of oral exercise on tongue pressure in Taiwanese older adults in community day care centers. [2022]

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

The Effects of Different Exercise Trainings on Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit in Healthy Subjects. [2021]