Lingual Strengthening Exercises for Swallowing Difficulty

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans with dysphagia (difficulty swallowing) by testing lingual strengthening exercises. Participants will follow an 8-week program designed to improve swallowing ability, with progress assessed at the start, midpoint, and end. The goal is to identify the best methods for measuring and predicting treatment success, enhancing personalized future care. Veterans diagnosed with dysphagia and having a treatment plan focused on strengthening swallowing muscles are well-suited for this study.

As an unphased trial, this study provides Veterans a unique opportunity to contribute to advancements in personalized dysphagia treatment.

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 prior data suggests that these lingual strengthening exercises are safe for Veterans with dysphagia?

Research has shown that tongue exercises are generally safe for people with swallowing problems. One study found that these exercises can improve swallowing in individuals who have had a stroke. Another study demonstrated that pressing the tongue against the roof of the mouth can strengthen the tongue and enhance swallowing.

These exercises are considered safe and typically do not cause pain or discomfort. Most studies have also found that they make swallowing safer. Therefore, for those considering joining a trial involving these exercises, research suggests they are safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for swallowing difficulties focus on dietary changes, medications, or surgical interventions. However, this trial explores lingual strengthening exercises, which are unique because they aim to directly enhance tongue strength and coordination. Unlike other methods that address symptoms, these exercises target the root cause by improving muscle function, potentially offering a more direct and non-invasive approach to treatment. Researchers are excited because this method could lead to improved swallowing ability and quality of life for patients with dysphagia without the need for more invasive procedures.

What evidence suggests that lingual strengthening exercises are effective for dysphagia?

Research has shown that tongue exercises can aid individuals with dysphagia, a condition characterized by difficulty swallowing. One study found that these exercises strengthened the tongues of older adults over an 8-week period, improving their swallowing issues. Another study discovered that stroke patients with swallowing difficulties could eat and swallow better after performing tongue exercises. These exercises also help control tongue pressure during swallowing, which is crucial for safe and easy eating. Overall, evidence suggests that tongue exercises can enhance swallowing and quality of life for those with dysphagia. Participants in this trial will be divided into two groups: a patient group receiving lingual strengthening exercises and a control group with no intervention. ^{2 5 6 7 8}

Who Is on the Research Team?

Timothy M. McCulloch, MD

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772632022000368

The effectiveness of tongue strengthening exercise in ... The results showed that TSE increases tongue strength in older people with dysphagia. The intervention duration was 8 weeks, with a frequency of three times a ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37195518/

Effects of Device-Facilitated Lingual Strengthening ... - PubMed Lingual strengthening exercise resulted in significant improvements in functional oral intake for patients with post-stroke dysphagia as compared to usual care ...

3. pubs.asha.org pubs.asha.org/doi/10.1044/2022_JSLHR-21-00331

Effects of Tongue-Strengthening Exercise on ... The results of this study suggest that TSE may improve the ability to regulate tongue pressure during swallowing and maintain it for a period of ...

4. nature.com nature.com/articles/s41598-022-14335-2

Effects of tongue strengthening exercises on ... - Nature This study provides positive evidence that TSE may be beneficial in improving tongue strength and could be applied for adults, especially healthy older adults.

5. withpower.com withpower.com/trial/phase-deglutition-disorders-5-2021-a0c2e

Lingual Strengthening Exercises for Swallowing Difficulty A study involving 29 older adults demonstrated that both progressive resistance tongue exercises and conventional isometric exercises significantly improved ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10537832/

Efficacy and safety of oropharyngeal muscle strength training ... In patients with poststroke oropharyngeal dysphagia, oropharyngeal muscle strength training can improve swallowing safety and performance.

7. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/swallowing-exercises-how-to-do-tonguestrengthening-exercises

Swallowing Exercises: How to Do Tongue-Strengthening ... What are the risks of tongue-strengthening exercises? Tongue-strengthening exercises and other swallowing exercises are safe. If you have pain or discomfort ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197457225004331

Effectiveness of self-administered tongue pressing effortful ... This study aimed to assess the effectiveness of self-administered TPES (Tongue Pressing Effortful Swallow) exercise on lip strength and endurance (LS, LE), ...