Swallow Muscle Exercises for Swallowing Disorders
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical College of Wisconsin
Disqualifiers: Muscle diseases, Neuro-muscular disorders, others
No Placebo Group
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.
12345Is 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.
15678How 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.
1591011Eligibility 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 am between 18 and 90 years old and in good health.
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.
+6 more
Trial 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
Participant Groups
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.
3Treatment groups
Active Control
Group I: Striated esophagus deglutitive motor function healthy adultsActive Control2 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 motilityActive Control2 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 manometryActive Control2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical College of WisconsinMilwaukee, WI
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
Feasibility and outcomes of fibreoptic endoscopic evaluation of swallowing following prophylactic swallowing rehabilitation in head and neck cancer. [2020]Investigate the feasibility and outcomes of fibreoptic endoscopic evaluation of swallowing (FEES) following a programme of prophylactic swallowing exercises in head and neck cancer (HNC) patients treated with radiotherapy.
Diagnosis with manometry and treatment with repetitive transcranial magnetic stimulation in Dysphagia. [2021]Videofluoroscopic swallowing study (VFSS) used for the diagnosis of dysphagia has limitations in objectively assessing the contractility of the pharyngeal muscle or the degree of the upper esophageal sphincter relaxation. With a manometer, however, it is possible to objectively assess the pressure changes in the pharynx caused by pharyngeal muscle contraction during swallowing or upper esophageal sphincter relaxation, hence remedying the limitations of VFSS. The following case report describes a patient diagnosed with lateral medullar infarction presenting a 52-year-old male who had dysphagia. We suggested that the manometer could be used to assess the specific site of dysfunction in patients with dysphagia complementing the limitations of VFSS. We also found that repetitive transcranial magnetic stimulation was effective in treating patients refractory to traditional dysphagia rehabilitation.
Inter-rater reliability and validity of automated impedance manometry analysis and fluoroscopy in dysphagic patients after head and neck cancer radiotherapy. [2015]Pharyngeal automated impedance manometry (AIM) analysis is a novel non-radiological method to analyze swallowing function based on impedance-pressure recordings. In dysphagic head and neck cancer patients, we evaluated the reliability and validity of the AIM-derived swallow risk index (SRI) and a novel measure of postswallow residue (iZn/Z) by comparing it against videofluoroscopy as the gold standard.
Case study: application of isometric progressive resistance oropharyngeal therapy using the Madison Oral Strengthening Therapeutic device. [2022]Isometric progressive resistance oropharyngeal (I-PRO) therapy improves swallowing function; however, current devices utilize a single sensor that provides limited information or are prohibitively expensive. This single-subject study presents results of I-PRO therapy, detraining, and maintenance using the 5-sensor Madison Oral Strengthening Therapeutic (MOST) device combined with upper esophageal sphincter (UES) dilatation.
A systematic review of current methodology of high resolution pharyngeal manometry with and without impedance. [2020]This systematic review appraises and summaries methodology documented in studies using high resolution pharyngeal manometry (HRM) with and without impedance technology (HRIM) in adult populations.
High-resolution impedance manometry parameters in the evaluation of esophageal function of non-obstructive dysphagia patients. [2022]High-resolution impedance manometry (HRIM) allows evaluation of esophageal bolus retention, flow, and pressurization. We explored novel HRIM measures and assessed their temporal relationship to dysphagia symptoms for boluses of different volume and consistency in non-obstructive dysphagia (NOD) patients.
A method to objectively assess swallow function in adults with suspected aspiration. [2022]Pharyngeal manometry and impedance provide information on swallow function. We developed a new analysis approach for assessment of aspiration risk.
Swallowing Exercise During Head and Neck Cancer Treatment: Results of a Randomized Trial. [2022]The diagnosis and treatment of head and neck cancer (HNC) can have substantial impact on swallowing function, nutritional balance, physical function and quality of life (QoL). Early initiated swallowing exercises are hypothesized to improve swallowing function in HNC patients. The aim was to investigate the effects of swallowing exercises and progressive resistance training (PRT) during radiotherapy on swallowing function, physical function and QoL in patients with pharynx-, larynx-, oral cavity cancer or unknown primary compared to usual care. In a multi-centre RCT participants were assigned to (a) twice-weekly PRT and daily swallowing exercises throughout treatment or (b) usual care. Outcomes were measured at end of treatment and 2, 6 and 12 months after. Primary outcome was penetration aspiration score (PAS). Data were analysed on an "intention-to-treat" basis by GEE logistic regression model, linear mixed effects model and cox regression. Of 371 invited HNC patients, 240 (65%) enrolled. Five participants were excluded. At 12 months follow-up, 59 (25%) participants were lost. Analyses showed significant effect on mouth opening, QoL, depression and anxiety at 12 months when comparing intervention to non-active controls. The trial found no effect on swallowing safety in HNC undergoing radiotherapy, but several positive effects were found on secondary outcomes when comparing to non-active controls. The intervention period may have been too short, and the real difference between groups is too small. Nevertheless, the need to identify long-lasting intervention to slow down or avoid functional deteriorations is ever more crucial as the surviving HNC population is growing.
Esophageal dysphagia and reflux symptoms before and after oral IQoro(R) training. [2018]To examine whether muscle training with an oral IQoro(R) screen (IQS) improves esophageal dysphagia and reflux symptoms.
Swallow strength training exercise for elderly: A health maintenance need. [2019]Recent studies have shown high prevalence of oropharyngeal dysphagia associated with frailty- and age-related muscle weakness. Strength training exercises have been advocated for locomotive health maintenance in the elderly and have shown positive outcomes. As muscles involved in oropharyngeal phase of swallowing are also comprised of striated muscles, the aim of this study was to determine biomechanical effect of a novel resistance exercise program, Swallowing Against Laryngeal Restriction (SALR), on pharyngeal phase swallowing in the healthy elderly.
Effects of Device-Facilitated Isometric Progressive Resistance Oropharyngeal Therapy on Swallowing and Health-Related Outcomes in Older Adults with Dysphagia. [2022]Swallowing disorders (dysphagia) are associated with malnutrition, aspiration pneumonia, and mortality in older adults. Strengthening interventions have shown promising results, but the effectiveness of treating dysphagia in older adults remains to be established. The Swallow STRengthening OropharyNGeal (Swallow STRONG) Program is a multidisciplinary program that employs a specific approach to oropharyngeal strengthening-device-facilitated (D-F) isometric progressive resistance oropharyngeal (I-PRO) therapy-with the goal of reducing health-related sequelae in veterans with dysphagia. Participants completed 8 weeks of D-F I-PRO therapy while receiving nutritional counseling and respiratory status monitoring. Assessments were completed at baseline, 4, and 8 weeks. At each visit, videofluoroscopic swallowing studies were performed. Dietary and swallowing-related quality of life questionnaires were administered. Long-term monitoring for 6-17 months after enrollment allowed for comparison of pneumonia incidence and hospitalizations to the 6-17 months before the program. Veterans with dysphagia confirmed with videofluoroscopy (N = 56; 55 male, 1 female; mean age 70) were enrolled. Lingual pressures increased at anterior (effect estimate = 92.5, P