Lingual Endurance Exercise in Treating Post-Stroke Dysphagia

Study Overview
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Brief Summary
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This study will enroll 15 participants in each exercise condition (groups described below). 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 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 Impairment (OI) score and Functional Oral Intake Scale (FOIS) score. Secondary outcome measures: oropharyngeal residue - Normalized Residue Ratio Scale (NRRS); airway invasion - Penetration Aspiration Scale (PAS). Patient reported outcome measures: EAT-10 (Eating Assessment Tool) and the Swallowing Quality of Life Questionnaire (SWAL-QoL). Aim 3: Determine if lingual endurance training + transference exercise (Exercise Group #2) results in better transference of exercise effects to the aforementioned outcomes of swallow safety and efficiency (in Aim2).

Detailed Description
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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.

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

Conditions
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Dysphagia, Oral Phase, Stroke, Ischemic

Intervention / Treatment
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* Other: Lingual Endurance Exercise
* Other: Lingual Endurance + Transference Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥3 months since initial diagnosis first-time, 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 exclusion criteria Final inclusion must include a score of one or greater in any oral or pharyngeal residue score on MBSImP they will qualify for study entry. Exclusion Criteria: a history of dysphagia prior to or after the stroke caused by any of the following conditions: gastrointestinal disease, traumatic brain injury, head and neck cancer, or a surgical procedure involving the pharynx or larynx a history of other neurological disease including traumatic brain injury, multiple sclerosis, Amyotrophic lateral sclerosis (ALS), Parkinson, or dementia Pregnant women Patients with a history of Temporomandibular joint dysfunction (TMJ) or Epilepsy

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized 1:1 into either the Lingual Endurance Training only (Group 1) or Lingual Endurance + Transference Exercise (Group 2)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lingual Endurance Training Only (Group 1)<br>Intervention group 1 will complete lingual endurance training only. | Other: Lingual Endurance Exercise<br>* Participants will participate in 3 training sessions per day for 8 weeks. Group 1 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.<br>|
| Experimental: Lingual Endurance Training + Transference Exercise (Group 2)<br>Intervention Group 2 will complete lingual endurance exercise plus a transference exercise. | Other: Lingual Endurance Exercise<br>* Participants will participate in 3 training sessions per day for 8 weeks. Group 1 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.<br>Other: Lingual Endurance + Transference Exercise<br>* Group 2 will complete lingual endurance exercise for 2 sessions, and for the 3rd training session participants will complete 30 swallows where they are instructed to press their tongue hard on the bulb and swallow their saliva. The TongueometerTM will provide biofeedback on performance and will be instructed to generate more pressure during this effortful swallow than during a natural, saliva swallow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | total number of days of attempted exercise/total number of days prescribed over 8 weeks of therapy | Assessed at 8 weeks (study completion) | 
| Dose Delivery | # of repetitions meeting goal/# prescribed repetitions (total for 8 weeks) | Assessed at 8 weeks (study completion) | 
| 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 | Change from Baseline | 
| Change from Baseline Eating Assessment Tool (EAT-10) Score | patient reported outcome tool; 0 = best score, 50 = worst score | Change from Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Worst Penetration Aspiration Scale (PAS) Score | measure of airway invasion during swallowing, best score = 1, worst score = 8 | Change from Baseline | 
| Change from Baseline in Normalized Residue Ratio Rating (NRRS) | measure of post-swallow residue, % of residue remaining based on total pharyngeal space (normalized per patient) | Change from Baseline | 
| 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 | Change from Baseline | 
| Change from Baseline Functional Oral Intake Scale (FOIS) Score | Measure of oral intake; 7 = best score (total oral intake, no restrictions); 1 = worst score (not safe for oral intake, feeding tube dependent) | Change from Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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swallowing, dysphagia, sub-acute stroke, tongue, exercise