Mild Cognitive ImpairmentNCT06766487
Effectiveness of Tongue Resistance Exercises on Tongue and Swallowing Function in Frail Older Adults With MCI
A study testing Tongue resistance exercises and cheek bulging exercises in people with Mild Cognitive Impairment, run by Chang Gung Medical Foundation at 1 site in Taiwan.
Trial summary
The purpose of this study is to explore the effects of tongue resistance exercises on tongue muscle strength and swallowing function in frail older adults with mild cognitive impairment living in the community. This study adopts a longitudinal research design with randomization. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Tongue resistance exercises and cheek bulging exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Jul 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Mild cognitive impairment in older adults aged ≥65 years
- Frailty assessment: at least 1 point
Who cannot join
- Having aspiration pneumonia
- Tracheotomy is retained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chang Gung Memorial Hospital at Linkou
The purpose of this study is to explore the effects of tongue resistance exercises on tongue muscle strength and swallowing function in frail older adults with mild cognitive impairment living in the community.
This study adopts a longitudinal research design with randomization. Participants were randomly assigned to two groups using an online computer-based randomization tool. The experimental group performed tongue resistance exercises, while the control group practiced cheek bulging exercises.
Read the detailed description
Recruitment took place in nursing homes, day care centers, and community care centers across Taiwan. Participants were older adults aged 65 years or older with mild cognitive impairment and frailty, enrolled between August 1, 2021, and July 31, 2022.
Participants were randomly divided into two groups by computer, 23 peoples per group, The experimental group performed tongue resistance exercises, while the control group practiced cheek bulging exercises. The exercise intervention is 12 weeks of exercise begins, with each session 30 minutes.
The evaluation items include basic information, outcomes collected through a Iowa Oral Performance Instrument (IOPI) was used to measure tongue strength, tongue endurance, tongue endurance time, saliva swallowing pressure, effortful saliva swallowing pressure, and Aspiration assessment. The measurement times are as follows: T0 (Baseline), T1 (Week 4, Mid-Intervention), T2 (Immediate Post-Test after the 12-Week Intervention), and T3 (Follow-Up after the 12-Week Intervention).
Before conducting the study, all participants received a complete explanation of the purpose, risks, and procedures of the investigation, and provided written informed consent. Procedures were in accordance with the ethical standards of the committee on human experimentation at the institution where the work was conducted, and this study was approved by the Institutional Review Board.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Tongue resistance exercises, cheek bulging exercises
- Keywords
- Tongue Resistance Exercises, Frail, Swallowing Function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue resistance exercisesBehavioural
The TRE program consisted of the following exercises:
Exercise 1: Tongue Protrusion and Retraction Against Resistance, Exercise 2: Anterior Tongue Protrusion and Retraction Against Resistance, Exercise 3: Middle Tongue Protrusion and Retraction Against Resistance, Exercise 4: Middle Tongue Elevation with Pharyngeal Sound Production, Exercise 5: Tongue Elevation and Posterior Sweeping, and Exercise 6: Saliva Swallowing with Lip Closure.
cheek bulging exercisesBehavioural
Cheek bulging exercises involved a series of movements: Lip Closure: Participants began by closing their lips. Unilateral Cheek Bulging: They then bulged their right cheek, followed by relaxation and return to the initial position. This was repeated on the left side. Bilateral Cheek Bulging: Finally, participants bulged both cheeks simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| Tongue Resistance Exercises | Experimental | TRTP involved movements of the tongue's anterior, middle, posterior, and lateral parts, targeting the intrinsic and extrinsic tongue muscles and the soft palate. Receives: Behavioral: Tongue resistance exercises |
| cheek bulging exercises | Placebo comparator | Cheek bulging exercises involved closing the lips, bulging the right cheek, relaxing and returning to the initial position, bulging the left cheek, relaxing and returning to the initial position, and finally bulging both cheeks simultaneously. Receives: Behavioral: cheek bulging exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue strength (anterior tongue strength [ATS] and posterior tongue strength [PTS])
Tongue strength was measured using IOPI (Model 3.1) device, which was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition . The bulb was placed on the palate inside the upper front teeth and at the junction of the hard palate and soft palate to measure ATS and PTS. Maximum isometric pressure (MIP) was defined as the pressure generated when the participant pushed the tongue forcefully against the palate and maintained it for 3 seconds for both the anterior and posterior tongue. Each exercise was performed thrice, with 1-minute intervals between trials. The highest value from the three trials was recorded. MIP is reported in terms of kilopascals. The average pressure values for the anterior and posterior parts of the tongue were 55.95 ± 14.13 kPa and 53.23 ± 12.24 kPa, respectively.
Measured: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Tongue Endurance (anterior tongue endurance [ATE] and posterior tongue endurance [PTE])
Tongue endurance was measured using IOPI (Model 3.1) device using the target mode with the target value set at 50% of the individual's MIP. The bulb was placed on either the anterior tongue or the posterior tongue to measure ATE and PTE. The participant pushed the tongue against the palate for 3 seconds. If the pressure exceeded the target value, the instrument displayed a green light indicating the goal had been achieved. Tongue endurance was assessed only once. For the assessment of tongue endurance, interrater reliability was .97, and interrater reliability was .95. Tongue weakness, defined as a tongue pressure of <30 kPa, is associated with a risk of malnutrition.At the indicated cutoff values, the assessment sensitivity was 92% (95% CI: 75% to 98%), specificity was 96% (95% CI: 87% to 99%), positive predictive value was 92% (95% CI: 75% to 98%), negative predictive value was 96% (95% CI: 87% to 99%), and accuracy was 94.7% (95% CI: 87% to 98%).
Measured: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Swallowing pressure (saliva swallowing pressure [SSP] and effortful swallow pressure [ESP]).
Saliva swallowing pressure (SSP) was measured using IOPI (Model 3.1). The IOPI device was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition. The bulb was placed on the palate inside the upper front teeth. The participant gently closed the mouth and then swallowed saliva normally (without pressing the bulb with the tongue). An SSP of <10.3 kPa among older adults is associated with an increased risk of aspiration pneumonia.Effortful Swallowing Pressure (ESP) was measured using IOPI (Model 3.1). The IOPI device was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition. The bulb was placed on the palate inside the upper front teeth. The participant gently closed the mouth performed an effortful saliva swallow (eg, an egg), but did not press the bulb with the tongue.
Measured: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Aspiration assessment
The references were developed using a structured evaluation form. Information for each option was obtained by interviewing the case or caregiver or by reviewing the institution's records. The evaluation included determining whether there had been a physician-diagnosed case of pneumonia, a fever ≥ 38℃, or respiratory symptoms such as coughing or difficulty breathing, as well as recording the dates of occurrence.
Measured: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Aug 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Model description
- The experimental group performed tongue resistance exercises, while the control group practiced cheek bulging exercises. This study adopts a longitudinal research design with randomization. Participants were randomly assigned to two groups using an online computer-based randomization tool.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University
- Responsible party
- Principal investigator, Kao, Shu-Hua, Chang Gung Medical Foundation
- Investigators
- Kao S Hua, Master, Study chair, Chang Gung Medical Foundation Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766487
- Sponsor's protocol ID
- N202001044
- Other IDs
- CMRPG5L0032
- Status last verified
- Jun 2023
- First submitted
- 3 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leira J, Maseda A, Lorenzo-Lopez L, Cibeira N, Lopez-Lopez R, Lodeiro L, Millan-Calenti JC. Dysphagia and its association with other health-related risk factors in institutionalized older people: A systematic review. Arch Gerontol Geriatr. 2023 Jul;110:104991. doi: 10.1016/j.archger.2023.104991. Epub 2023 Mar 7.
PubMed 36906939Namiki C, Hara K, Tohara H, Kobayashi K, Chantaramanee A, Nakagawa K, Saitou T, Yamaguchi K, Yoshimi K, Nakane A, Minakuchi S. Tongue-pressure resistance training improves tongue and suprahyoid muscle functions simultaneously. Clin Interv Aging. 2019 Mar 22;14:601-608. doi: 10.2147/CIA.S194808. eCollection 2019.
PubMed 30962680Kim HD, Choi JB, Yoo SJ, Chang MY, Lee SW, Park JS. Tongue-to-palate resistance training improves tongue strength and oropharyngeal swallowing function in subacute stroke survivors with dysphagia. J Oral Rehabil. 2017 Jan;44(1):59-64. doi: 10.1111/joor.12461.
PubMed 27883209Kao SH, Chen R, Su PY, Banda KJ, Sung CM, Wang CH, Chiang KJ, Fajarini M, Chou KR. A tongue resistance training program improves strength, endurance, and swallowing in frail older adults with mild cognitive impairment: a double-blind randomized controlled trial. Geroscience. 2026 Feb;48(1):647-660. doi: 10.1007/s11357-025-01715-5. Epub 2025 May 29.
PubMed 40439971
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chang Gung Memorial Hospital at Linkou
- ClinicalTrials.gov ID
- NCT06766487
- Acronym / sponsor ID
- N202001044
- Conditions
- Mild Cognitive Impairment
- Keywords
- Tongue Resistance Exercises, Frail, Swallowing Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Chang Gung Medical FoundationUniversity, hospital or other
- Collaborators
- Taipei Medical University
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 9 Jan 2025 (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 purpose of this study is to explore the effects of tongue resistance exercises on tongue muscle strength and swallowing function in frail older adults with mild cognitive impairment living in the community.
This study adopts a longitudinal research design with randomization. Participants were randomly assigned to two groups using an online computer-based randomization tool. The experimental group performed tongue resistance exercises, while the control group practiced cheek bulging exercises.
Detailed description
Recruitment took place in nursing homes, day care centers, and community care centers across Taiwan. Participants were older adults aged 65 years or older with mild cognitive impairment and frailty, enrolled between August 1, 2021, and July 31, 2022.
Participants were randomly divided into two groups by computer, 23 peoples per group, The experimental group performed tongue resistance exercises, while the control group practiced cheek bulging exercises. The exercise intervention is 12 weeks of exercise begins, with each session 30 minutes.
The evaluation items include basic information, outcomes collected through a Iowa Oral Performance Instrument (IOPI) was used to measure tongue strength, tongue endurance, tongue endurance time, saliva swallowing pressure, effortful saliva swallowing pressure, and Aspiration assessment. The measurement times are as follows: T0 (Baseline), T1 (Week 4, Mid-Intervention), T2 (Immediate Post-Test after the 12-Week Intervention), and T3 (Follow-Up after the 12-Week Intervention).
Before conducting the study, all participants received a complete explanation of the purpose, risks, and procedures of the investigation, and provided written informed consent. Procedures were in accordance with the ethical standards of the committee on human experimentation at the institution where the work was conducted, and this study was approved by the Institutional Review Board.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The experimental group performed tongue resistance exercises, while the control group practiced cheek bulging exercises. This study adopts a longitudinal research design with randomization. Participants were randomly assigned to two groups using an online computer-based randomization tool.
| Arm | Type | Receives |
|---|---|---|
| Tongue Resistance Exercises | Experimental | Behavioral: Tongue resistance exercisesTRTP involved movements of the tongue's anterior, middle, posterior, and lateral parts, targeting the intrinsic and extrinsic tongue muscles and the soft palate. |
| cheek bulging exercises | Placebo comparator | Behavioral: cheek bulging exercisesCheek bulging exercises involved closing the lips, bulging the right cheek, relaxing and returning to the initial position, bulging the left cheek, relaxing and returning to the initial position, and finally bulging both cheeks simultaneously. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Mild cognitive impairment in older adults aged ≥65 years
- Frailty assessment: at least 1 point
Key exclusion criteria (2 listed)
- Having aspiration pneumonia
- Tracheotomy is retained
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 exercisesThe TRE program consisted of the following exercises: Exercise 1: Tongue Protrusion and Retraction Against Resistance, Exercise 2: Anterior Tongue Protrusion and Retraction Against Resistance, Exercise 3: Middle Tongue Protrusion and Retraction Against Resistance, Exercise 4: Middle Tongue Elevation with Pharyngeal Sound Production, Exercise 5: Tongue Elevation and Posterior Sweeping, and Exercise 6: Saliva Swallowing with Lip Closure. | Behavioural | Tongue Resistance Exercises |
| cheek bulging exercisesCheek bulging exercises involved a series of movements: Lip Closure: Participants began by closing their lips. Unilateral Cheek Bulging: They then bulged their right cheek, followed by relaxation and return to the initial position. This was repeated on the left side. Bilateral Cheek Bulging: Finally, participants bulged both cheeks simultaneously. | Behavioural | cheek bulging exercises |
Primary outcome
Tongue strength (anterior tongue strength [ATS] and posterior tongue strength [PTS])
Time frame: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Tongue strength was measured using IOPI (Model 3.1) device, which was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition . The bulb was placed on the palate inside the upper front teeth and at the junction of the hard palate and soft palate to measure ATS and PTS. Maximum isometric pressure (MIP) was defined as the pressure generated when the participant pushed the tongue forcefully against the palate and maintained it for 3 seconds for both the anterior and posterior tongue. Each exercise was performed thrice, with 1-minute intervals between trials. The highest value from the three trials was recorded. MIP is reported in terms of kilopascals. The average pressure values for the anterior and posterior parts of the tongue were 55.95 ± 14.13 kPa and 53.23 ± 12.24 kPa, respectively.
Tongue Endurance (anterior tongue endurance [ATE] and posterior tongue endurance [PTE])
Time frame: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Tongue endurance was measured using IOPI (Model 3.1) device using the target mode with the target value set at 50% of the individual's MIP. The bulb was placed on either the anterior tongue or the posterior tongue to measure ATE and PTE. The participant pushed the tongue against the palate for 3 seconds. If the pressure exceeded the target value, the instrument displayed a green light indicating the goal had been achieved. Tongue endurance was assessed only once. For the assessment of tongue endurance, interrater reliability was .97, and interrater reliability was .95. Tongue weakness, defined as a tongue pressure of <30 kPa, is associated with a risk of malnutrition.At the indicated cutoff values, the assessment sensitivity was 92% (95% CI: 75% to 98%), specificity was 96% (95% CI: 87% to 99%), positive predictive value was 92% (95% CI: 75% to 98%), negative predictive value was 96% (95% CI: 87% to 99%), and accuracy was 94.7% (95% CI: 87% to 98%).
Swallowing pressure (saliva swallowing pressure [SSP] and effortful swallow pressure [ESP]).
Time frame: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Saliva swallowing pressure (SSP) was measured using IOPI (Model 3.1). The IOPI device was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition. The bulb was placed on the palate inside the upper front teeth. The participant gently closed the mouth and then swallowed saliva normally (without pressing the bulb with the tongue). An SSP of <10.3 kPa among older adults is associated with an increased risk of aspiration pneumonia.Effortful Swallowing Pressure (ESP) was measured using IOPI (Model 3.1). The IOPI device was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition. The bulb was placed on the palate inside the upper front teeth. The participant gently closed the mouth performed an effortful saliva swallow (eg, an egg), but did not press the bulb with the tongue.
Aspiration assessment
Time frame: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
The references were developed using a structured evaluation form. Information for each option was obtained by interviewing the case or caregiver or by reviewing the institution's records. The evaluation included determining whether there had been a physician-diagnosed case of pneumonia, a fever ≥ 38℃, or respiratory symptoms such as coughing or difficulty breathing, as well as recording the dates of occurrence.
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 9 Jan 2025.
- Results publication: PubMed 36906939Leira J, Maseda A, Lorenzo-Lopez L, Cibeira N, Lopez-Lopez R, Lodeiro L, Millan-Calenti JC. Dysphagia and its association with other health-related risk factors in institutionalized older people: A systematic review. Arch Gerontol Geriatr. 2023 Jul;110:104991. doi: 10.1016/j.archger.2023.104991. Epub 2023 Mar 7.
- Results publication: PubMed 30962680Namiki C, Hara K, Tohara H, Kobayashi K, Chantaramanee A, Nakagawa K, Saitou T, Yamaguchi K, Yoshimi K, Nakane A, Minakuchi S. Tongue-pressure resistance training improves tongue and suprahyoid muscle functions simultaneously. Clin Interv Aging. 2019 Mar 22;14:601-608. doi: 10.2147/CIA.S194808. eCollection 2019.
- Results publication: PubMed 27883209Kim HD, Choi JB, Yoo SJ, Chang MY, Lee SW, Park JS. Tongue-to-palate resistance training improves tongue strength and oropharyngeal swallowing function in subacute stroke survivors with dysphagia. J Oral Rehabil. 2017 Jan;44(1):59-64. doi: 10.1111/joor.12461.
- Derived from this study: PubMed 40439971Kao SH, Chen R, Su PY, Banda KJ, Sung CM, Wang CH, Chiang KJ, Fajarini M, Chou KR. A tongue resistance training program improves strength, endurance, and swallowing in frail older adults with mild cognitive impairment: a double-blind randomized controlled trial. Geroscience. 2026 Feb;48(1):647-660. doi: 10.1007/s11357-025-01715-5. Epub 2025 May 29.
- Individual participant dataSharing planned: No
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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.
Kao S Hua, Master study chair
Chang Gung Medical Foundation Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan
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 exercises and cheek bulging exercises in people with Mild Cognitive Impairment, run by Chang Gung Medical Foundation at 1 site in Taiwan.
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 2 inclusion and 2 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 9 Jan 2025. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Tongue strength (anterior tongue strength [ATS] and posterior tongue strength [PTS]) (time frame: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).). The study lists 4 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 NCT06766487, which also lists 4 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 9 Jan 2025.