Isotonic Endurance Exercise for Swallowing Difficulty After Stroke

Overseen By Rebecca Reinert

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Gastrointestinal disease, TBI, Cancer, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tongue exercise, called Isotonic Endurance Exercise, to assist people who struggle with swallowing after a stroke. The goal is to determine if this exercise can make swallowing safer and easier, potentially improving overall health and quality of life. Participants will either perform the actual exercise or a simulated version to compare results. Individuals who experienced a stroke 3-6 months ago and continue to have swallowing issues might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for stroke survivors.

Do I need to stop taking 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 exercise protocol is safe for individuals with post-stroke dysphagia?

Research shows that isotonic endurance exercises, the type under study, are generally safe for people, including older adults. These exercises can improve tongue strength and swallowing ability without major safety issues. Previous studies on tongue-strengthening exercises found that participants, even those who had a stroke, handled them well. No major reports of negative effects have emerged, suggesting these exercises are safe for rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for swallowing difficulty after a stroke involve dietary adjustments, swallowing exercises, and sometimes electrical stimulation. But researchers are excited about isotonic endurance exercise because it specifically targets lingual endurance, focusing on building the tongue's strength and stamina. This approach is unique because it uses isotonic repetitions to potentially enhance muscle endurance, which is different from traditional methods that primarily focus on compensatory strategies or general exercises. By re-evaluating each participant’s exercise regimen every two weeks, it allows for personalized adjustments, potentially leading to more effective improvements in swallowing functionality.

What evidence suggests that isotonic endurance exercise is effective for swallowing difficulty after stroke?

This trial will compare the effects of Isotonic Endurance Exercise with Sham Exercise for swallowing difficulty after a stroke. Research has shown that certain exercises can improve swallowing problems post-stroke. For instance, one study found that a 3-month program of mouth exercises significantly increased tongue strength in older adults, from 16.92 kPa to 20.63 kPa. Another study demonstrated that these exercises enhance tongue strength and swallowing in stroke survivors with swallowing difficulties. These exercises strengthen the tongue, which is crucial for safe swallowing. Overall, evidence suggests that tongue exercises can enhance swallowing function. ^{2 3 6 7 8}

Who Is on the Research Team?

Brittany Krekeler, PhD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for adults who have had a stroke within the last 3-6 months, leading to swallowing difficulties. They must be able to take some oral intake and follow commands. It's not for those under 18 or with dysphagia due to other conditions like head injuries, cancer, surgeries affecting throat structures, or neurological diseases.

Inclusion Criteria

Your score on the Modified Barium Swallow Study (MBSS) is higher than 10.

I had a stroke that wasn't caused by bleeding in the brain 3-6 months ago.

I can swallow some food or liquid for a swallowing test.

Exclusion Criteria

I have a history of a neurological disease like MS, ALS, Parkinson's, or dementia.

I have had swallowing problems due to a condition or surgery before or after a stroke.

I have never had swallowing problems due to a stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lingual endurance exercise or sham exercise for 8 weeks to improve swallow function

8 weeks

3 training sessions per day

Follow-up

Participants are monitored for changes in swallow function and neuroplasticity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Isotonic Endurance Exercise
• Sham Exercise

Trial Overview The study tests whether a new type of tongue exercise can help improve swallowing after a stroke. Participants will do either real exercises or sham (fake) ones as a comparison. The study also looks at brain changes using MRI scans to understand how the exercises affect recovery.

How Is the Trial Designed?

Group I: Lingual Endurance Exercise Experimental Treatment 1 Intervention

The experimental exercise group will participate in 3 training sessions per day for 8 weeks. Endurance exercise will include completing isotonic endurance repetitions 3 times a day. Number of repetitions per session will be determined during baseline testing, and re-evaluated every 2 weeks, for each participant.

Group II: Sham Exercise Placebo Group 1 Intervention

The sham control group will be instructed to press the lingual sensor 30 times at a very low-pressure threshold (approximately 1-15 kPa), which will be monitored weekly via device output sent to the study team to avoid use of excessive force that would qualify as exercise.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

TriHealth Inc.

Collaborator

Trials

103

Recruited

54,100+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

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]

Tongue-strengthening exercises (TSE) significantly increased maximum isometric tongue pressure and effortful swallowing pressure in 13 young healthy adults over an 8-week training period.

While the improvements in maximum isometric tongue pressure decreased after training stopped, the gains in effortful swallowing pressure were maintained for at least 8 weeks, suggesting TSE has lasting benefits for swallowing function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Tongue-Strengthening Exercise on Tongue Strength and Effortful Swallowing Pressure in Young Healthy Adults: A Pilot Study. Fukuoka, T., Ono, T., Hori, K., et al.[2022]

A 3-month oral exercise program significantly improved tongue pressure in 66 older adults, with measurements increasing from 16.92 kPa to 20.63 kPa, indicating enhanced swallowing function.

Participants with functional tooth units showed even greater improvements in tongue pressure, suggesting that oral health may influence the effectiveness of oral exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of oral exercise on tongue pressure in Taiwanese older adults in community day care centers. Chen, HH., Lin, PY., Lin, CK., et al.[2022]

Tongue strengthening exercises (TSE) significantly improve both anterior and posterior tongue strength compared to control groups, with a notable increase in strength measured in kilopascals (kPa) across 12 studies involving 388 participants.

The greatest improvements in anterior tongue strength were observed in older adults (≥ 65 years), suggesting that TSE could be particularly beneficial for this age group in enhancing swallowing function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tongue strengthening exercises on tongue muscle strength: a systematic review and meta-analysis of randomized controlled trials. Lin, CJ., Lee, YS., Hsu, CF., et al.[2022]

Lingual exercise significantly improved swallowing recovery in stroke patients, as evidenced by increased isometric and swallowing pressures after an 8-week program involving 10 participants.

The exercise also led to reduced airway invasion during liquid swallowing and increased lingual volume in some patients, highlighting its potential benefits for both acute and chronic dysphagia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of lingual exercise in stroke patients with dysphagia. Robbins, J., Kays, SA., Gangnon, RE., et al.[2022]

In a study of 243 Veterans undergoing an intensive lingual strengthening treatment for dysphagia, 38% showed nonadherence, defined as missing two or more follow-up sessions within 84 days.

A classification tree was developed to identify risk factors for nonadherence, revealing high-risk groups with rates between 69%-77%, based on variables like primary diagnosis and age, which could help target support for patients at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stratifying Risk of Nonadherence in Lingual Strengthening Dysphagia Rehabilitation. Vitale, K., Powell, WR., Krekeler, BN., et al.[2023]

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 pilot study with 29 healthy older adults, combining mental practice using motor imagery (MP-MI) with physical lingual exercises significantly improved maximum isometric pressure (MIP) and saliva swallowing pressure (RESS) after 6 weeks, indicating enhanced swallowing function.

The results suggest that integrating MP-MI into exercise regimens could be beneficial for older adults, potentially leading to better swallowing outcomes, and warrant further investigation in preventative and rehabilitative settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial Comparing Physical and Mental Lingual Exercise for Healthy Older Adults. Szynkiewicz, SH., Kamarunas, E., Drulia, T., et al.[2021]

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]

In a 4-week randomized controlled trial with 25 stroke patients, tongue stretching exercises (TSE) significantly improved tongue motility and oromotor function, including bolus formation and oral transit time, compared to a control group.

The results suggest that TSE is an effective treatment for dysphagia in stroke patients, enhancing their ability to manage swallowing more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tongue stretching exercises improve tongue motility and oromotor function in patients with dysphagia after stroke: A preliminary randomized controlled trial. Hwang, NK., Kim, HH., Shim, JM., et al.[2020]

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. 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5544365/

A Systematic Review of Isometric Lingual Strength-Training ... This systematic review summarizes the effects of isometric lingual strength training on lingual strength and swallow function in adult populations.

4. withpower.com withpower.com/trial/phase-deglutition-disorders-8-2023-d41ee

Isotonic Endurance Exercise for Swallowing Difficulty After ... A 3-month oral exercise program significantly improved tongue pressure in 66 older adults, with measurements increasing from 16.92 kPa to 20.63 kPa, indicating ...

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

Effects of Tongue-Strengthening Exercise on ... Tongue-to-palate resistance training improves tongue strength and oropharyngeal swallowing function in subacute stroke survivors with dysphagia.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9213467/

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

7. dysphagiarehablab.com dysphagiarehablab.com/projects

PROJECTS | DRL - Dysphagia Rehabilitation Lab The primary aim of this study is to examine the effects of lingual endurance exercise vs sham exercise in participants experiencing post-stroke dysphagia.

8. iopimedical.com iopimedical.com/studies/

IOPI-Related Studies Significant improvements in tongue strength and MASA scores were found after 8 weeks of training. After 4 weeks of no treatment no detraining occurred. FOIS ...