Focus of Study is Tongue StrengthNCT04809558
Optimal Method for Tongue Strengthening
A study testing Tongue resistance exercise in people with Focus of Study is Tongue Strength, run by Samford University at 1 site in United States.
Trial summary
The research team will conduct a multi-site, randomized controlled trial examining the effectiveness of exercise intensity progression compared to standard practice (no progression) in the context of swallowing rehabilitation. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus of Study is Tongue Strength
- What is being tested?
- Tongue resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are age 55 or older
- < 3 score on Eating Assessment Tool-10 (screening tool for swallowing difficulty)
- > 24 score on Mini Mental State Examination (screening tool for cognitive impairment)
- Have a normal oral structure as assessed with an oral mechanism screener
Who cannot join
- A history of seizures (contraindication for Tongueometer™ use)
- Past or present pain disorders involving the jaw or mandible (e.g., TMJ disorder, myofascial pain disorder) (contraindication for Tongueometer™ use)
- A history of oral surgery (routine dental surgery acceptable)
- A history of neurogenic disorder (e.g., Parkinson's disease)
- A history of swallowing difficulty
- Not being able to complete an 8-week study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining an Optimal Delivery Method for Tongue Strengthening During Swallowing Rehabilitation: Building a Framework for Clinical Practice
The research team will conduct a multi-site, randomized controlled trial examining the effectiveness of exercise intensity progression compared to standard practice (no progression) in the context of swallowing rehabilitation. The study will also determine the impact of using biofeedback during resistance training on tongue strength. The study is a first step in determining an optimal delivery of tongue strengthening exercise in typically aging older persons, with the plan to develop a framework for guiding clinical practice of tongue strengthening in various dysphagic populations. Participants will be randomized into one of four treatment groups and complete 8 weeks of tongue resistance training.
Read the detailed description
Rehabilitative exercises have been central to dysphagia (swallowing difficulty) treatment for decades, with the goal to increase strength, endurance, and/or coordination of the muscles responsible for swallowing. With any exercise-based therapy, an understanding of dosing is critical to optimize outcomes and to avoid over- or under-prescribing exercise, which can have a negative effect. For example, overtraining can lead to reductions in strength, which may put patients who are completing a swallowing rehabilitation program at increased risk. Therefore, it is important to develop dosing recommendations specific to swallowing musculature. Clinical practice remains unguided in terms of whether a progressive or maximum intensity, both common forms of rehabilitative exercise for dysphagic patients, should be used for lingual resistance training. Speech-Language Pathologists (SLP) currently base these decisions on preference and experience; however, research is desperately needed in this area to support and guide clinical decisions. The investigators aim to fill this gap in evidence by determining an optimal dosing for tongue strengthening in older persons. It is anticipated that the study findings will directly influence clinical decisions in both inpatient rehabilitation facilities and home health post-acute care settings, and ultimately improve patient outcomes in the area of swallowing. This study represents the start of a research program intended to provide significant information on optimal delivery of tongue strengthening exercise in various populations with difficulty swallowing.
To determine an optimal delivery method for tongue resistance training in healthy older persons by examining how intensity progression and biofeedback impacts tongue strength, participant motivation, and program adherence. The data collected in this initial study will inform future studies designed to develop a framework for guiding clinical practice with SLPs prescribing tongue strengthening exercise to patients with swallowing issues.
Primary Research Questions:
- Is tongue strength impacted by exercise resistance intensity when comparing progressive resistance to maximum resistance?
- Is tongue strength impacted by visual biofeedback during tongue resistance training?
Secondary Research Questions:
- Is participant motivation impacted by progressive intensity exercise when compared to maximum intensity exercise?
- Is participant motivation impacted by the use of biofeedback when compared to no visual biofeedback?
- Is participant adherence to the exercise program impacted by progressive intensity exercise when compared to maximum intensity exercise?
- Is participant adherence to the exercise program impacted by the use of biofeedback when compared to no visual biofeedback?
- Conditions
- Focus of Study is Tongue Strength
- Being tested
- Tongue resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue resistance exerciseBehavioural
Participant will complete tongue resistance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Max intensity with no visual biofeedback | Active comparator | Tongue resistance exercises completed at maximum intensity with no visual biofeedback. Receives: Behavioral: Tongue resistance exercise |
| Progressive intensity with no visual biofeedback. | Active comparator | Tongue resistance exercises completed at a progressive intensity with no visual biofeedback. Receives: Behavioral: Tongue resistance exercise |
| Max intensity with visual biofeedback | Active comparator | Tongue resistance exercises completed at maximum intensity with visual biofeedback of performance. Receives: Behavioral: Tongue resistance exercise |
| Progressive intensity with visual biofeedback. | Active comparator | Tongue resistance exercises completed at a progressive intensity with visual biofeedback of performance. Receives: Behavioral: Tongue resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum isometric tongue pressure (MIP)
MIP in kilopascals (kPa)
Measured: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
Change in regular effort saliva swallow pressure (RESS)
RESS is kilopascals (kPa)
Measured: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
Change in effortful swallow pressure (ESP)
ESP in kilopascals (kPa)
Measured: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
Secondary outcomes (3)
Change in participant-perceived motivation for assigned exercise regimen
Standardized 0 mm (lowest level of perceived motivation) to 100 mm (highest level of perceived motivation) visual-analog scale participant perception of internal motivation.
Measured: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
Change in participant-perceived confidence for assigned exercise regimen
Standardized 0 mm (lowest level of perceived confidence) to 100 mm (highest level of perceived confidence) visual-analog scale participant perception of internal confidence.
Measured: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
Exercise adherence tracking
Adherence tracking will be completed by asking participants to keep record form logs of sessions completed
Measured: Collected at Weeks, 2, 4, 6, 8; and 1-month post if participant was randomized to a maintenance program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jun 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Focus of Study is Tongue StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samford University
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Emerson College, James Madison University, Texas Christian University
- Responsible party
- Sponsor
- Investigators
- Sarah H Szynkiewicz, Ph.D., Principal investigator, Samford UniversityErin Kamarunas, Ph.D., Principal investigator, James Madison UniversityTeresa Drulia, Ph.D., Principal investigator, Texas Christian UniversityLindsay Griffin, Ph.D., Principal investigator, Emerson CollegeRachel Mulheren, Ph.D., Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809558
- Sponsor's protocol ID
- EXPD-HP-20-F-5
- Status last verified
- Dec 2022
- First submitted
- 12 Mar 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rhea MR, Alvar BA, Burkett LN, Ball SD. A meta-analysis to determine the dose response for strength development. Med Sci Sports Exerc. 2003 Mar;35(3):456-64. doi: 10.1249/01.MSS.0000053727.63505.D4.
PubMed 12618576Kamarunas E, Murray K, Drulia T, Szynkiewicz S, Griffin L, Mulheren R. Biofeedback and Exercise Load Affect Accuracy of Tongue Strength Exercise Performance. Dysphagia. 2025 Apr;40(2):489-500. doi: 10.1007/s00455-024-10751-w. Epub 2024 Aug 18.
PubMed 39154305
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining an Optimal Delivery Method for Tongue Strengthening During Swallowing Rehabilitation: Building a Framework for Clinical Practice
- ClinicalTrials.gov ID
- NCT04809558
- Acronym / sponsor ID
- EXPD-HP-20-F-5
- Conditions
- Focus of Study is Tongue Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Samford UniversityUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Emerson College, James Madison University, Texas Christian University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research team will conduct a multi-site, randomized controlled trial examining the effectiveness of exercise intensity progression compared to standard practice (no progression) in the context of swallowing rehabilitation. The study will also determine the impact of using biofeedback during resistance training on tongue strength. The study is a first step in determining an optimal delivery of tongue strengthening exercise in typically aging older persons, with the plan to develop a framework for guiding clinical practice of tongue strengthening in various dysphagic populations. Participants will be randomized into one of four treatment groups and complete 8 weeks of tongue resistance training.
Detailed description
Rehabilitative exercises have been central to dysphagia (swallowing difficulty) treatment for decades, with the goal to increase strength, endurance, and/or coordination of the muscles responsible for swallowing. With any exercise-based therapy, an understanding of dosing is critical to optimize outcomes and to avoid over- or under-prescribing exercise, which can have a negative effect. For example, overtraining can lead to reductions in strength, which may put patients who are completing a swallowing rehabilitation program at increased risk. Therefore, it is important to develop dosing recommendations specific to swallowing musculature. Clinical practice remains unguided in terms of whether a progressive or maximum intensity, both common forms of rehabilitative exercise for dysphagic patients, should be used for lingual resistance training. Speech-Language Pathologists (SLP) currently base these decisions on preference and experience; however, research is desperately needed in this area to support and guide clinical decisions. The investigators aim to fill this gap in evidence by determining an optimal dosing for tongue strengthening in older persons. It is anticipated that the study findings will directly influence clinical decisions in both inpatient rehabilitation facilities and home health post-acute care settings, and ultimately improve patient outcomes in the area of swallowing. This study represents the start of a research program intended to provide significant information on optimal delivery of tongue strengthening exercise in various populations with difficulty swallowing.
To determine an optimal delivery method for tongue resistance training in healthy older persons by examining how intensity progression and biofeedback impacts tongue strength, participant motivation, and program adherence. The data collected in this initial study will inform future studies designed to develop a framework for guiding clinical practice with SLPs prescribing tongue strengthening exercise to patients with swallowing issues.
Primary Research Questions:
- Is tongue strength impacted by exercise resistance intensity when comparing progressive resistance to maximum resistance?
- Is tongue strength impacted by visual biofeedback during tongue resistance training?
Secondary Research Questions:
- Is participant motivation impacted by progressive intensity exercise when compared to maximum intensity exercise?
- Is participant motivation impacted by the use of biofeedback when compared to no visual biofeedback?
- Is participant adherence to the exercise program impacted by progressive intensity exercise when compared to maximum intensity exercise?
- Is participant adherence to the exercise program impacted by the use of biofeedback when compared to no visual biofeedback?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Max intensity with no visual biofeedback | Active comparator | Behavioral: Tongue resistance exerciseTongue resistance exercises completed at maximum intensity with no visual biofeedback. |
| Progressive intensity with no visual biofeedback. | Active comparator | Behavioral: Tongue resistance exerciseTongue resistance exercises completed at a progressive intensity with no visual biofeedback. |
| Max intensity with visual biofeedback | Active comparator | Behavioral: Tongue resistance exerciseTongue resistance exercises completed at maximum intensity with visual biofeedback of performance. |
| Progressive intensity with visual biofeedback. | Active comparator | Behavioral: Tongue resistance exerciseTongue resistance exercises completed at a progressive intensity with visual biofeedback of performance. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are age 55 or older
- < 3 score on Eating Assessment Tool-10 (screening tool for swallowing difficulty)
- > 24 score on Mini Mental State Examination (screening tool for cognitive impairment)
- Have a normal oral structure as assessed with an oral mechanism screener
Key exclusion criteria (6 listed)
- A history of seizures (contraindication for Tongueometer™ use)
- Past or present pain disorders involving the jaw or mandible (e.g., TMJ disorder, myofascial pain disorder) (contraindication for Tongueometer™ use)
- A history of oral surgery (routine dental surgery acceptable)
- A history of neurogenic disorder (e.g., Parkinson's disease)
- A history of swallowing difficulty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongue resistance exerciseParticipant will complete tongue resistance exercises. | Behavioural | Max intensity with no visual biofeedback, Max intensity with visual biofeedback, Progressive intensity with no visual biofeedback., Progressive intensity with visual biofeedback. |
Primary outcome
Change in maximum isometric tongue pressure (MIP)
Time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
MIP in kilopascals (kPa)
Change in regular effort saliva swallow pressure (RESS)
Time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
RESS is kilopascals (kPa)
Change in effortful swallow pressure (ESP)
Time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
ESP in kilopascals (kPa)
3 secondary outcomes
Change in participant-perceived motivation for assigned exercise regimen
Time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
Change in participant-perceived confidence for assigned exercise regimen
Time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program
Exercise adherence tracking
Time frame: Collected at Weeks, 2, 4, 6, 8; and 1-month post if participant was randomized to a maintenance program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 12618576Rhea MR, Alvar BA, Burkett LN, Ball SD. A meta-analysis to determine the dose response for strength development. Med Sci Sports Exerc. 2003 Mar;35(3):456-64. doi: 10.1249/01.MSS.0000053727.63505.D4.
- Derived from this study: PubMed 39154305Kamarunas E, Murray K, Drulia T, Szynkiewicz S, Griffin L, Mulheren R. Biofeedback and Exercise Load Affect Accuracy of Tongue Strength Exercise Performance. Dysphagia. 2025 Apr;40(2):489-500. doi: 10.1007/s00455-024-10751-w. Epub 2024 Aug 18.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah H Szynkiewicz, Ph.D. principal investigator
Samford University
Erin Kamarunas, Ph.D. principal investigator
James Madison University
Teresa Drulia, Ph.D. principal investigator
Texas Christian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue resistance exercise in people with Focus of Study is Tongue Strength, run by Samford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum isometric tongue pressure (MIP) (time frame: Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04809558, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.