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

Trial Summary

What is the purpose of this trial?

Swallowing impairments (dysphagia) frequently occur after stroke and have devastating consequences on overall health and quality of life, and long-term deficits in swallow function also increase risk of morbidity (e.g. depression) and mortality (i.e. aspiration pneumonia). As such, rehabilitation of swallow function to improve safety and efficiency of swallowing is essential in this population. This study aims to: 1) Provide preliminary data to evaluate the effect of a novel lingual endurance exercise on swallow function in individuals with post-stroke dysphagia; and 2) Collect preliminary data regarding changes in white matter tract diffusion and cortical thickness and from MRI data to better understand effects of lingual exercise training on neuroplasticity.

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 data supports the effectiveness of the treatment Isotonic Endurance Exercise for Swallowing Difficulty After Stroke?

Research shows that lingual (tongue) exercises can help improve swallowing in stroke patients. Studies have found that combining physical and mental tongue exercises can increase swallowing pressure, suggesting that similar exercises might help with swallowing difficulties after a stroke. ^{1 2 3 4 5}

Is isotonic endurance exercise for swallowing difficulty after stroke safe for humans?

Research on tongue strengthening exercises, which are similar to isotonic endurance exercises, suggests they are generally safe for humans, including older adults and those recovering from a stroke. ^{3 5 6 7 8}

How is the Isotonic Endurance Exercise treatment for swallowing difficulty after stroke different from other treatments?

Isotonic Endurance Exercise is unique because it focuses on strengthening the tongue through specific exercises, which can improve swallowing function. Unlike other treatments, it may involve using computer games to increase motivation and enhance tongue motor performance, making it a novel approach for stroke patients with swallowing difficulties. ^{1 5 6 9 10}

Research Team

Brittany Krekeler, PhD

Principal Investigator

University of Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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]

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]

References

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

The effects of lingual exercise in stroke patients with dysphagia. [2022]

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

A Randomized Controlled Trial Comparing Physical and Mental Lingual Exercise for Healthy Older Adults. [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. England 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. [2020]

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

Effects of Tongue-Strengthening Exercise on Tongue Strength and Effortful Swallowing Pressure in Young Healthy Adults: A Pilot Study. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of oral exercise on tongue pressure in Taiwanese older adults in community day care centers. [2022]

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

Stratifying Risk of Nonadherence in Lingual Strengthening Dysphagia Rehabilitation. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effects of tongue strengthening exercises on tongue muscle strength: a systematic review and meta-analysis of randomized controlled trials. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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