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Lingual Endurance Exercise in Treating Post-Stroke Dysphagia

Effects of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairment After Ischemic Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05523973
Enrollment
19
Registered
2022-09-01
Start date
2022-08-02
Completion date
2023-11-28
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Oral Phase, Stroke, Ischemic

Keywords

swallowing, dysphagia, sub-acute stroke, tongue, exercise

Brief summary

Aim 1: Determine feasibility of lingual endurance training for individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: % patient adherence (# of attempted repetitions/# prescribed repetitions) and % dose delivery (# of repetitions meeting goal/# prescribed repetitions). Aim 2: Determine preliminary efficacy of lingual endurance training on improving critical aspects of oropharyngeal swallowing (physiologic impairments, clearance of oropharyngeal residue, airway protection), functional oral intake, and patient reported swallowing quality of life in individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: improvement on videofluoroscopic assessment of swallowing function using the gold standard Modified Barium Swallowing Impairment Profile (MBSImP) Overall Impression (OI) score and Functional Oral Intake Scale (FOIS) score. Secondary outcome measures: Analysis of Swallow Physiology, Events, Timing and Kinematics (ASPEKT); airway invasion - Penetration Aspiration Scale (PAS). Patient reported outcome measures: EAT-10 (Eating Assessment Tool) and the Swallowing Quality of Life Questionnaire (SWAL-QoL).

Detailed description

Implications of Post-Stroke Dysphagia Dysphagia (swallowing impairment) after stroke is common, estimated to affect 78% of patients.1 Dysphagia results in additional negative consequences that complicate patient recovery and increase the risk of developing pulmonary complications (aspiration pneumonia) and may result in suboptimal nutrition. These comorbidities increase cost of care, up to $6,243 on average per patient, placing a burden not only on the individual, but also the healthcare system at large. The effects of dysphagia post-stroke extend beyond physical health concerns and increase the risk of depression, with devastating impacts on quality of life. Given these undesirable and dangerous health consequences, adequate assessment and treatment of swallowing impairments after stroke is a critical component of rehabilitation for this patient population. Limitations to Current Treatment Approaches Current treatment approaches to alleviate dysphagia after stroke, especially in acute and sub-acute phases, have primarily focused on diet modification, compensatory posturing, and providing alternate access to hydration and nutrition. While the goal of these strategies is to improve swallow safety and avoid negative consequences of airway invasion, these techniques can be burdensome to the patient if implemented long-term. Additionally, these approaches do not target rehabilitation of swallowing function, but rather provide a somewhat temporary solution to what is, for many patients, a life-long issue. Available rehabilitative approaches to target improvements in function of oropharyngeal musculature during swallowing include both swallowing exercises (task-specific) and non-swallowing exercises (e.g. tongue exercise), which rely on the principles of transference to improve swallowing function. However, evidence is inconsistent regarding efficacy of these exercise-based interventions that target the oropharyngeal musculature, and the scientific validity of these trials varies greatly. Of these non-swallowing exercise approaches, lingual (tongue) exercise has been frequently studied and can be facilitated by medical devices which provide bio-feedback of lingual pressure generative capabilities to the patient and clinician. However, there is little to no evidence that lingual strengthening improves swallow physiology or functional outcomes in post-stroke dysphagia, and a majority of these previous studies lack use of standardized outcomes or randomized controlled trial procedures. Also, lingual strengthening may not induce biological changes to tongue muscle fiber size, as would be expected with a resistance-based exercise program. Despite these mixed findings, lingual strengthening is still routinely to treat post-stroke dysphagia. A major limitation of these current approaches is a sole focus on increasing muscular strength alone without consideration for other aspects of muscle physiology necessary for swallowing, such as endurance. Lingual Endurance Training as an Alternative Approach In this preliminary study, we have proposed to examine the effects of lingual endurance training in individuals with dysphagia after stroke, as an alternative approach to traditional progressive lingual strength training, because this patient group is known to have specific deficits in lingual function after stroke. Both oral and pharyngeal tongue movements are essential for safe and efficient swallowing. Thus, exercise of the lingual musculature is a reasonable goal. However, swallowing is an endurance task; lingual pressures required for swallowing are submaximal, requiring repeated and sustained contraction over the course of a meal. Thus, targeting improvement in lingual endurance over strength alone may provide greater transferrable benefit to daily swallowing tasks. However, there are currently no randomized controlled trials investigating efficacy of lingual endurance training as a treatment for dysphagia in any patient population. As such, this proposed preliminary trial is essential to gathering the necessary pilot evidence regarding whether lingual endurance training is feasible and effective as an alternative approach to dysphagia rehabilitation for individuals with swallowing impairments after stroke. The long-term goal of this proposed work is to develop improved, evidence-based protocols for lingual exercise training for individuals with dysphagia after stroke. Ultimately, the results of this proposed pilot will be highly significant in creating movement towards more specific and evidence-based approaches for this unique patient group, who currently have very few rehabilitative options available. In this initial trial, we will assess if lingual endurance training will be feasible (Aim 1) and effective (Aim 2) for improving swallowing function in post-stroke dysphagia.

Interventions

OTHERLingual Endurance Training

Participants will participate in 3 training sessions per day for 8 weeks. Some participants will complete 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. Other participants will complete effortful swallows during their 3rd training session. These participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Cincinnati
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Some participants will practice only lingual endurance exercise 3 times a day, others will have a effortful swallow exercise to practice in place of their third session.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥3 months since initial diagnosis ischemic, non-hemorrhagic stroke occurring in areas involving anterior or posterior circulation and affecting underlying cortical or subcortical structures (including brainstem) * are safe to tolerate some oral intake required for assessment of swallowing function via Modified Barium Swallow Study * able to follow 2-step commands * English speaking. Participants will not be considered for inclusion if they meet any of the following screening

Design outcomes

Primary

MeasureTime frameDescription
AdherenceAssessed at 8 weeks (study completion)% \[(total number of days of attempted exercise/total number of days prescribed over 8 weeks of therapy)x100\]
Change From Baseline Modified Barium Swallowing Impairment Profile (MBSImP) Oral Total ScoreBaseline and 8 WeeksImprovement on Oral Total (OT) score MBSImP; OT score minimum score (best) =0; OT maximum score (worst) = 22

Secondary

MeasureTime frameDescription
Change From Baseline in Post-swallow Residue (Puree)Baseline and 8 WeeksAnalysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Change From Baseline in Post-swallow Residue (Thin Liquids)Baseline and 8 WeeksAnalysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Change From Baseline in Post-swallow Residue (Mildly Thick Liquids)Baseline and 8 WeeksAnalysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Participant Improving Worst Penetration Aspiration Scale (PAS) ScoreBaseline and 8 Weeksmeasure of airway invasion during swallowing, best score = 1, worst score = 8 Number of patients who improved worst PAS score from baseline to 8 week timepoint
Change From Baseline in Swallowing Quality of Life Questionnaire (SWAL-QoL)Baseline and 8 WeeksPatient reported outcome measure of swallowing quality of life, 0 = best score; 100 = worst score
Change From Baseline Eating Assessment Tool (EAT-10) ScoreBaseline and 8 Weekspatient reported outcome tool; 0 = best score, 50 = worst score
Change From Baseline in Post-swallow Residue (Moderately Thick Liquids)Baseline and 8 WeeksAnalysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)
Change From Baseline in Post-swallow Residue (Solid)Baseline and 8 WeeksAnalysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)

Countries

United States

Participant flow

Participants by arm

ArmCount
Lingual Endurance Training
Intervention group will complete lingual endurance training. Half of the participants also completed effortful swallows once per day Lingual Endurance Exercise: Participants will participate in 3 training sessions per day for 8 weeks. Half of the participants completed 3 sessions of lingual endurance exercise. For example, if the participant completed 100 repetitions during the baseline measurement, they would complete 75 repetitions during their exercise session. The other half completed 2 of these sessions, with 1 session of effortful swallow practice (10 repetitions)
19
Total19

Baseline characteristics

CharacteristicLingual Endurance Training
Age, Continuous66 years
STANDARD_DEVIATION 13.6
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
15 Participants
Region of Enrollment
United States
19 participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
13 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 19
other
Total, other adverse events
0 / 19
serious
Total, serious adverse events
2 / 19

Outcome results

Primary

Adherence

% \[(total number of days of attempted exercise/total number of days prescribed over 8 weeks of therapy)x100\]

Time frame: Assessed at 8 weeks (study completion)

Population: Only participants that completed baseline and final visits

ArmMeasureValue (MEAN)Dispersion
Lingual Endurance TrainingAdherence79 percentage of adherenceStandard Deviation 29
Primary

Change From Baseline Modified Barium Swallowing Impairment Profile (MBSImP) Oral Total Score

Improvement on Oral Total (OT) score MBSImP; OT score minimum score (best) =0; OT maximum score (worst) = 22

Time frame: Baseline and 8 Weeks

ArmMeasureValue (MEAN)Dispersion
Lingual Endurance TrainingChange From Baseline Modified Barium Swallowing Impairment Profile (MBSImP) Oral Total Score0.2667 score on a scaleStandard Deviation 2.82
p-value: 0.66Wilcoxon (Mann-Whitney)
Secondary

Change From Baseline Eating Assessment Tool (EAT-10) Score

patient reported outcome tool; 0 = best score, 50 = worst score

Time frame: Baseline and 8 Weeks

ArmMeasureValue (MEAN)Dispersion
Lingual Endurance TrainingChange From Baseline Eating Assessment Tool (EAT-10) Score-0.0667 score on a scaleStandard Deviation 4.93
p-value: 0.92Sign test
Secondary

Change From Baseline in Post-swallow Residue (Mildly Thick Liquids)

Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)

Time frame: Baseline and 8 Weeks

ArmMeasureValue (MEAN)Dispersion
Lingual Endurance TrainingChange From Baseline in Post-swallow Residue (Mildly Thick Liquids)-1.01 percent of C2-C4Standard Deviation 2.58
p-value: 0.15Sign test
Secondary

Change From Baseline in Post-swallow Residue (Moderately Thick Liquids)

Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)

Time frame: Baseline and 8 Weeks

ArmMeasureValue (MEAN)Dispersion
Lingual Endurance TrainingChange From Baseline in Post-swallow Residue (Moderately Thick Liquids).25 percent of C2-C4Standard Deviation 5
p-value: 0.8Sign test
Secondary

Change From Baseline in Post-swallow Residue (Puree)

Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)

Time frame: Baseline and 8 Weeks

ArmMeasureValue (MEAN)Dispersion
Lingual Endurance TrainingChange From Baseline in Post-swallow Residue (Puree)-.67 percent of C2-C4Standard Deviation 6.6
p-value: 0.722Sign test
Secondary

Change From Baseline in Post-swallow Residue (Solid)

Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)

Time frame: Baseline and 8 Weeks

ArmMeasureValue (MEAN)Dispersion
Lingual Endurance TrainingChange From Baseline in Post-swallow Residue (Solid)-1.33 percent of C2-C4Standard Deviation 2.5
p-value: 0.09Sign test
Secondary

Change From Baseline in Post-swallow Residue (Thin Liquids)

Analysis of Swallowing Physiology, Kinematics, Events, Timing (ASPEKT): The ASPEKT method uses ImageJ pixel based measures of post-swallow residue (Total% of C2-C4)

Time frame: Baseline and 8 Weeks

ArmMeasureValue (MEAN)Dispersion
Lingual Endurance TrainingChange From Baseline in Post-swallow Residue (Thin Liquids)-1.5 percent of C2-C4Standard Deviation 4.2
p-value: 0.28Sign test
Secondary

Change From Baseline in Swallowing Quality of Life Questionnaire (SWAL-QoL)

Patient reported outcome measure of swallowing quality of life, 0 = best score; 100 = worst score

Time frame: Baseline and 8 Weeks

ArmMeasureValue (MEAN)Dispersion
Lingual Endurance TrainingChange From Baseline in Swallowing Quality of Life Questionnaire (SWAL-QoL)8.3 score on a scaleStandard Deviation 18.74
p-value: 0.12t-test, 2 sided
Secondary

Participant Improving Worst Penetration Aspiration Scale (PAS) Score

measure of airway invasion during swallowing, best score = 1, worst score = 8 Number of patients who improved worst PAS score from baseline to 8 week timepoint

Time frame: Baseline and 8 Weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Lingual Endurance TrainingParticipant Improving Worst Penetration Aspiration Scale (PAS) Score6 Participants
p-value: 1Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026