Swallow Muscle Exercises for Swallowing Disorders

Overseen By Mark Kern

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Muscle diseases, Neuro-muscular disorders, others

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

Compensation: Varies

Number of Visits: 2

557 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the impact of exercises for swallowing muscles on swallowing difficulties. Researchers will assess throat muscle function during swallowing in both healthy adults and individuals with swallowing problems, using a special machine to track muscle movements. The trial includes various groups: healthy adults, those with inefficient esophagus movement, and those with swallowing symptoms but normal test results. It suits individuals with swallowing issues but normal esophagus muscle function test results. As an unphased trial, this study allows participants to contribute to foundational research that could enhance understanding and treatment of swallowing difficulties.

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 prior data suggests that this swallow muscle exercising device is safe for swallowing disorders?

Research has shown that strengthening throat muscles can aid those who struggle with swallowing after a stroke. However, specific safety information about the exercise device used in the trial is not available.

Manometry and fluoroscopy are common methods for studying swallowing problems. Manometry measures how well food moves through the esophagus, especially when combined with impedance. This method is considered safe when used with fluoroscopy, a type of X-ray that allows doctors to view the inside of the body.

In summary, while detailed safety data for the exercise device is lacking, techniques like manometry and fluoroscopy used in the study are generally safe and well-tolerated in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring innovative ways to improve swallowing disorders by focusing on the muscles involved in swallowing. Unlike current treatments that often rely on dietary changes, medication, or surgery, this approach uses a swallow muscle exercising device combined with advanced techniques like manometry and impedance, which help measure muscle function and coordination. The trial also examines the impact of laryngeal restriction, providing a comprehensive look at how different interventions can enhance swallowing efficiency. By understanding these interactions, the hope is to develop more effective, non-invasive therapies for swallowing disorders.

What evidence suggests that this trial's treatments could be effective for swallowing disorders?

Research has shown that swallowing exercises can enhance swallowing ability. These exercises have been particularly beneficial for patients with head and neck cancer. In this trial, participants will use a swallow muscle exercising device, which may significantly reduce the risk of accidentally inhaling food or liquid. High-resolution manometry and impedance provide detailed images and information about how the throat and esophagus muscles function during swallowing. This data aids in understanding and potentially improving swallowing problems. ^{1 6 7 8 9}

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 adults aged 18 to 90 with difficulty swallowing (dysphagia) but normal esophageal muscle function tests. It's not for those under 18, recent head and neck cancer patients, people allergic to lidocaine or barium, pregnant or lactating women, medically unstable individuals, those unable to use a swallow muscle exerciser even with help, cognitively impaired persons, or patients with certain muscle and neuromuscular diseases.

Inclusion Criteria

I have swallowing difficulties but my esophagus muscle test results are normal.

Exclusion Criteria

I am under 18 years old.

I had surgery for head or neck cancer less than a month ago or chemo radiation less than 3 months ago.

I have a condition affecting my muscle and nerve connection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Study

Baseline studies conducted using concurrent HRM/Impedance and digital video-fluoroscopy in upright and supine positions

1 session

1 visit (in-person)

Exercise Regimen

Participants undergo s-RED assisted or sham exercise three times a day for six weeks

6 weeks

Phone follow-up for compliance

Post-Exercise Study

Studies repeated post-exercise to compare baseline and exercise results

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the exercise regimen

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Concurrent manometry/impedance and fluoroscopy before and after six weeks of using swallow muscle exercising device
• Concurrent manometry/impedance and fluoroscopy with and without laryngeal restriction

Trial Overview

The study is testing how the muscles in the throat affect swallowing by using special imaging techniques before and after six weeks of exercises designed to strengthen these muscles. Participants will undergo assessments with and without restricting throat movements.

How Is the Trial Designed?

Group I: Striated esophagus deglutitive motor function healthy adults Active Control 2 Interventions

Testing of manometric, impedance and biomechanical measurements during swallowing in healthy volunteer adult subjects.

Group II: Striated esophagus deglutitive motor function in patients with ineffective esophageal motility Active Control 2 Interventions

Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with ineffective esophageal motility.

Group III: Striated esophagus deglutitive motor function patients with symptoms but normal esophageal manometry Active Control 2 Interventions

Testing of manometric, impedance and biomechanical measurements during swallowing in adult patients with symptoms of dysphagia but "normal" esophageal manometry by the Chicago Classification criteria.

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 of 33 non-obstructive dysphagia (NOD) patients, high-resolution impedance manometry (HRIM) revealed that bolus perception increased with the consistency of the bolus, indicating that thicker substances are more likely to be noticed by patients.

Patients with esophagogastric junction outflow obstruction (EGJOO) showed higher levels of bolus retention and restricted esophageal emptying compared to those with minor or no peristalsis disorders, suggesting that these HRIM measures could help identify abnormal swallowing patterns and improve understanding of dysphagia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution impedance manometry parameters in the evaluation of esophageal function of non-obstructive dysphagia patients. Singendonk, MJ., Lin, Z., Scheerens, C., et al.[2022]

A systematic review of 62 studies on high resolution pharyngeal manometry (HRM) and high resolution impedance manometry (HRIM) revealed significant variability in methodology, which can hinder the ability to replicate studies and compare results effectively.

Most studies used the ManoScan™ system and reported the use of topical anesthesia, but only a small percentage provided data on measurement reliability, highlighting a need for improved methodological reporting in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of current methodology of high resolution pharyngeal manometry with and without impedance. Winiker, K., Gillman, A., Guiu Hernandez, E., et al.[2020]

A new analysis method using pharyngeal manometry and impedance measurements was developed to assess the risk of aspiration in patients, showing that specific pressure-flow variables can effectively predict aspiration risk.

The Swallow Risk Index (SRI), derived from these measurements, demonstrated a strong correlation with aspiration scores, indicating it can reliably identify patients at risk for aspiration during swallowing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A method to objectively assess swallow function in adults with suspected aspiration. Omari, TI., Dejaeger, E., van Beckevoort, D., et al.[2022]

Pharyngeal automated impedance manometry (AIM) provides a more reliable assessment of swallowing function compared to traditional videofluoroscopy, with better inter-rater reliability for measures like the swallow risk index (SRI) and postswallow residue (iZn/Z).

The AIM-derived SRI and iZn/Z effectively identify clinically relevant swallowing dysfunction in dysphagic head and neck cancer patients, showing significant differences in patients with aspiration compared to age-matched controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inter-rater reliability and validity of automated impedance manometry analysis and fluoroscopy in dysphagic patients after head and neck cancer radiotherapy. Szczesniak, MM., Maclean, J., Zhang, T., et al.[2015]

In a study of 43 adults with long-lasting esophageal dysphagia, 98% showed significant improvement in swallowing and reflux symptoms after 6-8 months of training with the oral IQoro(R) screen, indicating its efficacy as a treatment.

The training led to measurable increases in muscle strength and pressure in the diaphragmatic hiatus, suggesting that the mechanism of action involves enhanced hiatal competence, which may help alleviate symptoms of dysphagia and reflux.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal dysphagia and reflux symptoms before and after oral IQoro(R) training. Hägg, M., Tibbling, L., Franzén, T.[2018]

Fibreoptic endoscopic evaluation of swallowing (FEES) is a feasible and acceptable method for assessing swallowing in head and neck cancer patients undergoing prophylactic swallowing exercises, with high data completion rates and positive patient feedback.

Post-radiotherapy, patients experienced a significant decline in swallowing safety, particularly with liquid boluses, and an increase in pharyngeal residue, highlighting the need for ongoing assessment and intervention in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of fibreoptic endoscopic evaluation of swallowing following prophylactic swallowing rehabilitation in head and neck cancer. Patterson, J., Toft, K., McAuley, F., et al.[2020]

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]

In a study involving 240 head and neck cancer patients, early initiation of swallowing exercises and progressive resistance training during radiotherapy showed significant improvements in quality of life, depression, and anxiety at the 12-month follow-up compared to usual care.

However, the intervention did not significantly improve swallowing safety, indicating that while the exercises may enhance overall well-being, they may not directly address swallowing function in patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swallowing Exercise During Head and Neck Cancer Treatment: Results of a Randomized Trial. Hajdú, SF., Wessel, I., Dalton, SO., et al.[2022]

The use of a manometer allows for objective assessment of pharyngeal muscle contraction and upper esophageal sphincter relaxation, addressing the limitations of videofluoroscopic swallowing studies (VFSS) in diagnosing dysphagia.

Repetitive transcranial magnetic stimulation (rTMS) was found to be effective in treating dysphagia in patients who did not respond to traditional rehabilitation methods, suggesting a promising alternative therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis with manometry and treatment with repetitive transcranial magnetic stimulation in Dysphagia. Rhee, WI., Won, SJ., Ko, SB.[2021]

The Swallow STRONG Program, which includes 8 weeks of device-facilitated isometric progressive resistance oropharyngeal therapy, significantly improved swallowing strength and quality of life in 56 veterans with dysphagia, as evidenced by increased lingual pressures and improvements in 8 out of 11 quality of life measures.

Participants experienced a significant reduction in hospital admissions after the program, indicating potential long-term benefits, while there was a notable 67% reduction in pneumonia diagnoses, suggesting the program may help reduce serious health complications associated with dysphagia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Device-Facilitated Isometric Progressive Resistance Oropharyngeal Therapy on Swallowing and Health-Related Outcomes in Older Adults with Dysphagia. Rogus-Pulia, N., Rusche, N., Hind, JA., 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]

Citations

1.

theajo.com

theajo.com/article/view/4563/html

Clinical application of pharyngeal high-resolution ...

Pharyngeal high-resolution manometry with impedance (P-HRM-I) is an emerging, ambulatory swallow assessment for patients with pharyngeal dysphagia.

2.

gastrojournal.org

gastrojournal.org/article/S0016-5085(08)00869-X/fulltext

High-Resolution Manometry and Impedance-pH ...

Both high-resolution manometry (HRM) and impedance-pH/manometry monitoring have established themselves as research tools and both are now emerging in the ...

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/nmo.70042

Defining Pharyngeal and Upper Esophageal Sphincter ...

Pharyngeal high-resolution manometric swallowing assessment utilizes swallowing measures that objectively assess different aspects of pharyngo- ...

4.

researchgate.net

researchgate.net/publication/301202673_The_Reliability_of_Pharyngeal_High_Resolution_Manometry_with_Impedance_for_Derivation_of_Measures_of_Swallowing_Function_in_Healthy_Volunteers

The Reliability of Pharyngeal High Resolution Manometry ...

The Reliability of Pharyngeal High Resolution Manometry with Impedance for Derivation of Measures of Swallowing Function in Healthy Volunteers.

5.

link.springer.com

link.springer.com/article/10.1007/s11894-017-0552-2

Diagnosis of Swallowing Disorders: How We Interpret ...

High-resolution manometry with impedance provides a visual depiction of pressure flow during pharyngeal deglutition, assessable qualitatively by ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9380031/

High-resolution impedance manometry parameters in the ...

High-resolution impedance manometry (HRIM) allows evaluation of esophageal bolus retention, flow, and pressurization. We explored novel HRIM measures and ...

7.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/nmo.70042?msockid=22193b565e466dae323c2d6a5fac6c50

Defining Pharyngeal and Upper Esophageal Sphincter ...

Note: *Standalone manometry is not recommended in these circumstances, however, may be deemed safe to perform with concurrent direct vision/ ...

8.

pubs.asha.org

pubs.asha.org/doi/abs/10.1044/2019_PERS-SIG13-2018-0007

Translating High-Resolution Manometry From Research to ...

Impedance analysis using high-resolution impedance manometry facilitates assessment of pharyngeal residue in patients with oropharyngeal dysphagia. Journal ...

9.

researchgate.net

researchgate.net/figure/Simultaneous-videofluoroscopy-and-pharyngeal-High-Resolution-Manometry-HRM-a_fig1_355485338

Simultaneous videofluoroscopy and pharyngeal High- ...

During simultaneous high-resolution manometry and videofluoroscopy, participants swallowed 10 trials of 2 mL, 10 trials of 10 mL, and up to 10 trials of a ...