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

Trial Summary

What is the purpose of this trial?

The investigators hypothesize that striated esophagus deglutitive motor function is modulated by pharyngeal phase swallowing biomechanics.

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 Swallow Muscle Exercises for Swallowing Disorders?

The use of high-resolution pharyngeal manometry (HRM) with impedance can help assess swallowing function by measuring pressure changes during swallowing, which complements traditional methods like videofluoroscopy. Additionally, isometric progressive resistance oropharyngeal therapy has been shown to improve swallowing function, suggesting that similar exercises could be beneficial for swallowing disorders. ^{1 2 3 4 5}

Is the swallow muscle exercising device safe for humans?

The research does not provide specific safety data for the swallow muscle exercising device, but it does mention that swallowing exercises in head and neck cancer patients did not negatively impact swallowing safety, suggesting a general safety in similar contexts. ^{1 5 6 7 8}

How is the Swallow Muscle Exercises treatment for swallowing disorders different from other treatments?

This treatment is unique because it combines advanced diagnostic techniques like manometry (pressure measurement) and fluoroscopy (X-ray imaging) with a specialized device for exercising swallow muscles, focusing on improving muscle strength and coordination, which is not typically addressed by standard treatments. ^{1 5 9 10 11}

Research Team

Reza Shaker, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of fibreoptic endoscopic evaluation of swallowing following prophylactic swallowing rehabilitation in head and neck cancer. [2020]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Diagnosis with manometry and treatment with repetitive transcranial magnetic stimulation in Dysphagia. [2021]

3. England 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. [2015]

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. Germany pubmed.ncbi.nlm.nih.gov

A systematic review of current methodology of high resolution pharyngeal manometry with and without impedance. [2020]

6. England pubmed.ncbi.nlm.nih.gov

High-resolution impedance manometry parameters in the evaluation of esophageal function of non-obstructive dysphagia patients. [2022]

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

A method to objectively assess swallow function in adults with suspected aspiration. [2022]

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

Swallowing Exercise During Head and Neck Cancer Treatment: Results of a Randomized Trial. [2022]

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

Esophageal dysphagia and reflux symptoms before and after oral IQoro(R) training. [2018]

10. England pubmed.ncbi.nlm.nih.gov

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

11. United States 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. [2022]