Lingual Strengthening Exercises for Swallowing Difficulty

Recruiting at 2 trial locations

Overseen By Jenna W Quinto, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Allergy to barium, anesthetics

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

222 Participants Needed

Trial Summary

What is the purpose of this trial?

This multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures. The investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Standard of Care Lingual Strengthening for swallowing difficulty?

Research shows that lingual strengthening exercises can improve swallowing function in older adults and those recovering from a stroke. These exercises increase tongue strength, which is important for better swallowing. ^{1 2 3 4 5}

Is lingual strengthening safe for humans?

Lingual strengthening exercises, used to improve swallowing, have been studied in various groups, including healthy adults and the elderly, with no reported safety concerns. These exercises are generally considered safe for humans. ^{1 2 3 4 5}

How is the Standard of Care Lingual Strengthening treatment different from other treatments for swallowing difficulty?

The Standard of Care Lingual Strengthening treatment is unique because it focuses on exercises to improve tongue strength, which can enhance swallowing function. Unlike other treatments, it may involve using devices like the Iowa Oral Performance Instrument (IOPI) to measure and guide the exercises, and it can be combined with engaging methods like computer games to increase motivation. ^{1 2 3 4 5}

Research Team

Timothy M. McCulloch, MD

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Eligibility Criteria

This trial is for Veterans who have difficulty swallowing (dysphagia) and are undergoing treatment to strengthen their throat muscles. They must be able to speak English, consent to participate, and have been diagnosed with dysphagia by a speech-language pathologist. Those allergic to barium or topical anesthetics cannot join.

Inclusion Criteria

English speaking

I am following a plan to strengthen my throat muscles due to swallowing difficulties.

Signed an informed consent form

Exclusion Criteria

You have had an allergic reaction to barium before.

You have had an allergic reaction to numbing creams used on the skin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal

8 weeks

3 visits (in-person) at baseline, 4 weeks, and 8 weeks

Follow-up

Participants are monitored for changes in swallowing function and other outcome measures

4 weeks

Treatment Details

Interventions

• Standard of Care Lingual Strengthening

Trial Overview The study tests the effectiveness of standard care exercises aimed at strengthening throat muscles in Veterans with dysphagia over 8 weeks. It compares changes in swallowing function against non-dysphagic controls using various assessments and aims to develop predictive algorithms for treatment success.

Participant Groups

Group I: Patient group Experimental Treatment 1 Intervention

lingual strengthening

Group II: Controls Active Control 1 Intervention

No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

In a study involving nine healthy adults aged 22 to 38, it was found that tongue motor performance improved when participants moved their tongues downward and during the third round of a computer game, indicating that practice and movement direction significantly influence performance.

Younger adults performed better overall, while performance declined with age, suggesting that age may affect tongue motor skills, which could be important for designing effective swallowing rehabilitation exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new method for tongue rehabilitation with computer games: Pilot study. Furlan, RMMM., Santana, GA., Bischof, WF., et al.[2022]

A study involving 29 older adults demonstrated that both progressive resistance tongue exercises and conventional isometric exercises significantly improved swallowing function and lingual strength over 12 sessions in 4 weeks.

There was no significant difference in the effectiveness of the two exercise methods, indicating that both approaches are equally beneficial for enhancing tongue strength in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Progressive Head Extension Swallowing Exercise on Lingual Strength in the Elderly: A Randomized Controlled Trial. Park, JW., Oh, CH., Choi, BU., et al.[2021]

Progressive lingual resistance training significantly improved functional oral intake in individuals with dysphagia after stroke, showing a notable difference compared to usual care after 8 weeks.

Participants in the treatment group also demonstrated large improvements in lingual pressure generation, indicating that this exercise may enhance swallowing capabilities, although further research with larger sample sizes is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Device-Facilitated Lingual Strengthening Therapy on Dysphagia Related Outcomes in Patients Post-Stroke: A Randomized Controlled Trial. Krekeler, BN., Yee, J., Kurosu, A., et al.[2023]

Isometric lingual strength training has shown positive effects on increasing maximum peak lingual pressures in both healthy adults and some individuals with dysphagia, suggesting it may help improve swallowing function.

However, the variability in study designs makes it difficult to determine if these strength gains translate into actual improvements in swallowing function, indicating a need for more standardized research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Isometric Lingual Strength-Training Programs in Adults With and Without Dysphagia. McKenna, VS., Zhang, B., Haines, MB., et al.[2022]

References

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

A new method for tongue rehabilitation with computer games: Pilot study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Progressive Head Extension Swallowing Exercise on Lingual Strength in the Elderly: A Randomized Controlled Trial. [2021]

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

Effects of Device-Facilitated Lingual Strengthening Therapy on Dysphagia Related Outcomes in Patients Post-Stroke: A Randomized Controlled Trial. [2023]

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

A Systematic Review of Isometric Lingual Strength-Training Programs in Adults With and Without Dysphagia. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Submental Muscle Activation During Lingual Tasks in Healthy Adults. [2019]