Isotonic Endurance Exercise for Swallowing Difficulty After Stroke
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Cincinnati
Disqualifiers: Gastrointestinal disease, TBI, Cancer, others
No Placebo Group
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.
12345Is 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.
35678How 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.
156910Eligibility 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.
+1 more
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.
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lingual Endurance ExerciseExperimental Treatment1 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 ExercisePlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of CincinnatiCincinnati, OH
Loading ...
Who Is Running the Clinical Trial?
University of CincinnatiLead Sponsor
National Institutes of Health (NIH)Collaborator
TriHealth Inc.Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
The effects of lingual exercise in stroke patients with dysphagia. [2022]To examine the effects of lingual exercise on swallowing recovery poststroke.
A Randomized Controlled Trial Comparing Physical and Mental Lingual Exercise for Healthy Older Adults. [2021]Mental practice using motor imagery (MP-MI) has been shown to improve motor outcomes of upper and lower extremities especially when combined with physical exercise. Here, we studied community-dwelling, healthy older adults to determine the effects of including an MP-MI component with lingual strengthening exercise. In this pilot study, twenty-nine typically aging participants were assigned to an intervention group: physical lingual exercise (n = 7), physical and MP-MI lingual exercise (n = 8), MPMI lingual exercise (n = 7), or a control group (placebo exercise) (n = 7). All participants completed the assigned exercise regimen with three sessions per day, three days a week, for 6 consecutive weeks. Maximum isometric pressure (MIP) and regular effort saliva swallowing (RESS) pressure were collected at baseline and weeks 2, 4, and 6. A post hoc Bonferroni corrected treatment effect from baseline to week 6 was shown for only participants in the MP-MI/Physical exercise group for MIP (p = 0.003 MPMI/ Physical group; p = 0.11 Control group; p = 0.32 Physical only group; p = 0.14 MP-MI only group) and RESS (p = 0.009 MP-MI/Physical group; p = 0.14 Control group; p = 0.10 Physical only group; p = 0.04 MP-MI only group). Findings also indicate spontaneous carryover of significantly increased swallowing pressure when mental and physical exercise are combined. In conclusion, the potential effect of including an MPMI lingual exercise component in preventative and rehabilitative frameworks with older persons to possibly enhance functional swallowing improvement is promising and should be investigated.
Effects of Device-Facilitated Lingual Strengthening Therapy on Dysphagia Related Outcomes in Patients Post-Stroke: A Randomized Controlled Trial. [2023]Swallowing impairments resulting from stroke have few rehabilitative options. Prior evidence suggests lingual strengthening exercise may provide some benefit, but more randomized controlled trials are required. The purpose of this study was to examine efficacy of progressive lingual resistance training on lingual pressure generative capacity and swallowing outcomes for individuals with dysphagia after stroke.
Tongue stretching exercises improve tongue motility and oromotor function in patients with dysphagia after stroke: A preliminary randomized controlled trial. [2020]This study investigated the effect of tongue stretching exercises (TSE) on tongue motility and oromotor function in patients with dysphagia after stroke.
Effects of Tongue-Strengthening Exercise on Tongue Strength and Effortful Swallowing Pressure in Young Healthy Adults: A Pilot Study. [2022]The purpose of this study was to investigate the effects of tongue-strengthening exercise (TSE) on tongue strength and effortful swallowing pressure in young healthy adults.
Effects of oral exercise on tongue pressure in Taiwanese older adults in community day care centers. [2022]Oral exercise is a training method for swallowing dysfunction in older adults. The study investigated the effect of oral exercise on tongue pressure in older adults in Taiwanese community day care centers over a 3-month period.
Stratifying Risk of Nonadherence in Lingual Strengthening Dysphagia Rehabilitation. [2023]Exercise-based treatments may improve swallowing safety and efficiency; yet, it is not clearly understood which factors predict nonadherence to recommended treatment protocols. The aim of this study was to construct an algorithm for stratifying risk of nonadherence to a lingual strengthening dysphagia treatment program.
Effects of tongue strengthening exercises on tongue muscle strength: a systematic review and meta-analysis of randomized controlled trials. [2022]Tongue strengthening exercise (TSE) has been proposed as an intervention to increase tongue strength and improve swallowing. However, clinical evidence of its effectiveness is lacking. In this review, seven databases were searched from inception to September 30, 2021 for randomized controlled trials that compared tongue strengths between the TSE intervention and control groups, obtained from maximal tongue elevation peak force in kilopascals (kPa). The Cochrane risk of bias tool was used for quality assessment. In total, 12 studies with 388 participants were included. The pooled meta-analysis demonstrated that the anterior tongue strength (ATS) (MD = 5.34 kPa; 95% CI 3.28-7.40; I2 = 71%) and posterior tongue strength (MD = 8.12; 95% CI 3.45-12.79; I2 = 90%) were significantly higher in the TSE intervention than that in the control group. Among healthy participants, subgroup analysis showed that TSE had improvements on ATS in all age groups, with the greatest improvement in old people (≥ 65 years) (MD = 8.01; 95% CI 4.39-11.64; I2 = 30%). Meta-regression analysis revealed a nonsignificant trend toward greater improvement on tongue strength with increasing TSE duration. This study provides positive evidence that TSE may be beneficial in improving tongue strength and could be applied for adults, especially healthy older adults.
Effect of Progressive Head Extension Swallowing Exercise on Lingual Strength in the Elderly: A Randomized Controlled Trial. [2021]Lingual strengthening training can improve the swallowing function in older adults, but the optimal method is unclear. We investigated the effects of a new progressive resistance exercise in the elderly by comparing with a conventional isometric tongue strengthening exercise. Twenty-nine participants were divided into two groups randomly. One group performed forceful swallow of 2 mL of water every 10 s for 20 min, and a total of 120 swallowing tasks per session at 80% angle of maximum head extension. The other group performed five repetitions in 24 sets with a 30 s rest, and the target level was settled at 80% of one repetition maximum using the Iowa Oral Performance Instrument (IOPI). A total of 12 sessions were carried out by both groups over a 4-week period. Blinded measurements (for maximum lingual isometric pressure and peak pressure during swallowing) were obtained using IOPI before exercise and at four weeks in both groups. After four weeks, both groups showed a significant improvement in lingual strength involving both isometric and swallowing tasks. However, there was no significant difference between the groups in strength increase involving both tasks. Regardless of the manner, tongue-strengthening exercises substantially improved lingual pressure in the elderly with equal effect.
A new method for tongue rehabilitation with computer games: Pilot study. [2022]Lingual exercises are commonly used in clinical practice for swallowing rehabilitation. Associating lingual exercises with computer games increases motivation, which influences tongue motor performance.