Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05523973
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2022-08-25
Brief Title:
Lingual Endurance Exercise in Treating Post-Stroke Dysphagia
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
Effects of Lingual Endurance Exercise on Rehabilitation of Swallowing Impairment After Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
Implications of Post-Stroke Dysphagia Dysphagia swallowing impairment after stroke is common estimated to affect 78 of patients1 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 6243 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None