Dysphagia, OropharyngealNCT06490705
The Efficacy of Tongue Exercises on Swallowing Function in the Elderly With Mild Cognitive Impairment
A study testing tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises in people with Dysphagia, Oropharyngeal, 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 muscle strength and resistance exercises on dysphagia, tongue muscle strength, oral hygiene, repetitive saliva swallowing, nutrition, depression, and swallowing-related quality of life in frail elderly people with mild cognitive impairment in the community. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Oropharyngeal
- What is being tested?
- tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Nov 2021to 25 Jan 2024
- 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
- A. Elderly individuals aged 65 years and above.
- B. Frailty assessment in older adults: Score of at least 1 point.
- C. Cognitive function assessment: Score of >=16 for individuals with no education; >=20 for those with elementary education; >=24 for those with junior high school education or higher.
Who cannot join
- A. Severe communication barrier.
- B. Unable to move independently or requires assistance.
- C. Unable to raise head or neck.
- D. Recent use of anticholinergic medications, asthma medications, or central nervous system depressants (Benzodiazepines).
- E. Aspiration pneumonia.
- F. Tracheostomy in place.
- G. Neuromuscular disorder.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital at Linkou
Taoyuan City, Taoyuan City, 333
About this study
Official title: Chang Gung Memorial Hospital at Linkou
The purpose of this study is to explore the effects of tongue muscle strength and resistance exercises on dysphagia, tongue muscle strength, oral hygiene, repetitive saliva swallowing, nutrition, depression, and swallowing-related quality of life in frail elderly people with mild cognitive impairment in the community.
This is a longitudinal research design using cluster randomization. Participants were randomly divided into three groups by computer: Experimental Group 1 received tongue resistance exercises; Experimental Group 2 received both tongue strengthening exercises and tongue resistance exercises; and the control group received oral and cheek bulging exercises.
Read the detailed description
Recruitment was carried out in nursing homes, day passport centers, and community care centers in New Taipei City and Taoyuan City, Taiwan. The subjects were elderly people aged 65 years or older with cognitive impairment and frailty, recruited from November 19, 2021, to January 25, 2024.Participants were randomly divided into three groups by computer, 30 people per group, Group 1 received tongue resistance exercises, Group 2 received both tongue strengthening exercises and tongue resistance exercises, Group 3: control group received oral and cheek bulging exercises.
The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). Participants received exercise 6 days a week, 3 times a day (before meals), with each session lasting 30 minutes.
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
- Dysphagia, Oropharyngeal
- Being tested
- tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tongue resistance exercises, tongue strengthening exercises and tongue resistance exercisesOther
Also called cheek bulging exercises
6 days a week, 3 times a day (before meals), with each session lasting 30 minutes. Don't hold your breath during exercise.
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 at which the work was conducted and this study was approved by the Institutional Review Board.
| Study group | Role | What they receive |
|---|---|---|
| Tongue resistance exercises | Experimental | Participants received tongue resistance exercises 6 days a week, 3 times a day (before meals), with each session lasting 30 minutes.
The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). Receives: Other: tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises |
| Tongue strengthening exercises and tongue resistance exercises | Experimental | Participants received tongue strengthening exercises and tongue resistance exercises 6 days a week, 3 times a day (before meals), with each session lasting 30 minutes.
The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). Receives: Other: tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises |
| cheek bulging exercises | Active comparator | Participants received cheek bulging exercises6 days a week, 3 times a day (before meals), with each session lasting 30 minutes.
The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). Receives: Other: tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty assessment
Based on the Fried 2001 frailty assessment scale, there are 5 items. The assessment takes only 3 minutes and uses a scoring system of 0 and 1. The possible total score ranges from 0 to 5 points, with higher scores indicating a more severe tendency towards frailty.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Activities of Daily Living (ADL)
The Activities of Daily Living (ADL) Assessment Scale consists of 10 items: eating, transferring, personal hygiene, toileting, bathing, walking on flat ground, climbing stairs, dressing and undressing, bowel control, and bladder control. Each item is graded on a scale of 2-4, ranging from complete dependence to complete independence, with scores incrementing by 5 points. The total score is out of 100 points. Scores from 0 to 20 indicate complete dependence; scores from 21 to 60 indicate severe dependence; scores from 61 to 90 indicate moderate dependence.
Measured: OT1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Instrumental Activities of Daily Living (IADLs)
The Instrumental Activities of Daily Living (IADL) Assessment consists of 8 items, each scored dichotomously (1 or 0), with a maximum total score of 8 points. The number of lost functions helps differentiate the severity of functional impairment, with higher scores indicating greater independence in older adults. The assessment is based on performance over the past month, obtained through observation, interviews with the individual, caregivers, or institutional records. The maximum score is 8 points; for male subjects, cooking, laundry, and housekeeping are not assessed, reducing the total score to 5 points. Mild disability is defined as needing assistance in three or more of the following five areas: shopping, going out, cooking, housekeeping, and laundry.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) evaluates cognitive functions across five domains: orientation, registration, attention and calculation, short-term memory, language comprehension, spatial awareness, and ability to perform tasks. The assessment typically takes 5 to 10 minutes to administer. The maximum score is 30 points, with higher scores indicating better cognitive abilities. Each correct answer earns one point. A total score of <= 24 indicates mild cognitive impairment, while a score below 16 indicates severe cognitive impairment (Bleecker, Bolla-Wilson, Kawas, \& Agnew, 1988). However, these cutoffs should be adjusted according to educational level: for individuals with elementary education or less, <= 20 indicates mild cognitive impairment, and <= 16 indicates severe cognitive impairment.
Measured: Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Geriatric depression assessment (GDS)
The Geriatric Depression Scale assesses 15 items reflecting the individual's condition over the past week. Points are assigned as follows: Questions 1, 5, 7, 11, and 13 score 1 point if answered "No"; Questions 2, 3, 4, 6, 8, 9, 10, 12, 14, and 15 score 1 point if answered "Yes". Data is obtained through observation, interviews with the individual or caregivers. The total score ranges from 0 to 15 points. Cutoff points: Scores of 0-4 indicate good mental and emotional adaptation. Scores of 5-9 suggest mild depressive tendencies, recommending psychological counseling or professional consultation. Scores of 10-15 indicate more severe depressive tendencies, recommending referral to psychiatric treatment or professional counseling.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Functional oral intake assessment (FOIS)
The Functional Oral Intake Assessment consists of 7 items used to evaluate and observe how individuals consume food and liquids orally, categorized into stages 1-7. Stage 1 indicates no oral intake, while stage 7 indicates unrestricted oral intake with no limitations. The assessment is based on observing the individual's eating and swallowing abilities or reviewing institutional dietary records. Cutoff points: Stages 1-3 indicate dependence on tube feeding, while stages 4-7 indicate full oral intake.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Difficulty of mouth process (DOMP)
The Swallowing Difficulty Index is used to observe the severity of swallowing difficulties in study subjects, categorized into 0-4 stages. Stage 0 indicates severe difficulty, with significant oral residue, food scattered to the cheeks and beside the tongue, and frequent drooling. Stage 2 indicates moderate severity, with slow eating speed, poor water flow dynamics, some residue beside the tongue, and possible drooling. Stage 3 indicates mild severity, with slightly slower eating speed, slightly open lips, and occasional drooling. Stage 4 indicates normal swallowing function.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Oral health assessment tool (OHAT)
The Oral Health Assessment Scale consists of 8 assessment items: lips, tongue, gums, toothache, saliva, teeth, dentures, and oral hygiene. Each item is scored from 0 to 2 points, where 0 points indicate health and 2 points indicate poor health. Higher scores indicate worse oral health. Data is collected by assessing the individual's oral condition or checking institutional records.
Score calculation: Scores range from 0 to 16 points, with higher scores indicating poorer oral health.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Swallowing-related quality of life assessment (SWQOL)
The Swallowing Quality of Life Questionnaire consists of 9 assessment items totaling 40 questions and 5 situational inquiries. It assesses the individual's experiences over the past month, their perception of their swallowing ability, and their sensations during swallowing.
Scoring criteria: Items 1-9 (total of 40 questions) are scored on a 5-point Likert scale: "Always" scores 1 point (90-100% frequency/intensity), "Often" scores 2 points (60-80% frequency/intensity), "Sometimes" scores 3 points (30-50% frequency/intensity), "Rarely" scores 4 points (10-20% frequency/intensity), and "Never" scores 5 points (0% frequency/intensity). Questions 10-14 are supplemented by situational inquiries.Score calculation: Scores range from 40 to 200 points, with higher scores indicating better daily functioning and better quality of life.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Iowa Oral Performance Instrument (IOPI)
IOPI was used to measure tongue strength, tongue endurance, tongue endurance time, saliva swallowing pressure, effortful saliva swallowing pressure, and the strength of the left and right lips.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Mini-nutrition assessment(MNA)
To assess the nutritional status of elderly individuals, the scale consists of a total of 18 items divided into nutritional screening (total score of 14 points) and general assessment (total score of 16 points), resulting in a maximum total score of 30 points. Each item is graded according to its scoring level.
If the nutritional screening score is 11 or less, further nutritional assessment is required, completing questions G-R to determine the "malnutrition indicator value." Nutritional assessment: Complete assessments for questions G-R, incorporate them into the total assessment score, and determine the "malnutrition indicator value." Cutoff points: 24 to 30 points = normal nutritional status; 17 to 23.5 points = at risk of malnutrition; less than 17 points = malnourished.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Repetitive saliva swallowing test (RSST)
The repetitive saliva swallowing test measures the number of rapid swallows in 30 seconds. The difficulty swallowing index during the pharyngeal phase will be used to observe the number of times the individual swallows saliva in 30 seconds, with a total of 3 assessment items. 1 point is scored if it does not reach three times, and 0 points are scored if the sensation of swallowing motion cannot be felt on the Adam's apple. The cutoff points are as follows: a score of 1 or below indicates a high-risk group for chewing and swallowing disorders, while a score of 2 indicates normal swallowing function.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Aspiration assessment
To obtain information for each option, use the aspiration assessment form to interview the case or caregiver, or check the institution's records: whether there has been a physician-diagnosed pneumonia, fever ≥ 38℃, respiratory symptoms like coughing or difficulty breathing, and the dates of occurrence.
Measured: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start19 Nov 2021
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dysphagia, OropharyngealStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a longitudinal research design using cluster randomization. Participants were randomly divided into three groups by computer, 30 people per group: Group 1 received tongue resistance exercises. Group 2 received both tongue strengthening exercises and tongue resistance exercises. Group 3: control group received oral and cheek bulging exercises. The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). Participants received exercise 6 days a week, 3 times a day (before meals), with each session lasting 30 minutes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 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 Memorial Hospital at Linkou, Taipei Medical University, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490705
- Sponsor's protocol ID
- ChangGungMF
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plans to make individual participant data (IPD) available to other researchers.
Publications
Jones E, Speyer R, Kertscher B, Denman D, Swan K, Cordier R. Health-Related Quality of Life and Oropharyngeal Dysphagia: A Systematic Review. Dysphagia. 2018 Apr;33(2):141-172. doi: 10.1007/s00455-017-9844-9. Epub 2017 Sep 2.
PubMed 28866854Lazarus C, Logemann JA, Huang CF, Rademaker AW. Effects of two types of tongue strengthening exercises in young normals. Folia Phoniatr Logop. 2003 Jul-Aug;55(4):199-205. doi: 10.1159/000071019.
PubMed 12802092Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PubMed 5349366Park T, Kim Y. Effects of tongue pressing effortful swallow in older healthy individuals. Arch Gerontol Geriatr. 2016 Sep-Oct;66:127-33. doi: 10.1016/j.archger.2016.05.009. Epub 2016 Jun 3.
PubMed 27318884Rech RS, de Goulart BNG, Dos Santos KW, Marcolino MAZ, Hilgert JB. Frequency and associated factors for swallowing impairment in community-dwelling older persons: a systematic review and meta-analysis. Aging Clin Exp Res. 2022 Dec;34(12):2945-2961. doi: 10.1007/s40520-022-02258-x. Epub 2022 Oct 7.
PubMed 36207669Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8. doi: 10.1016/j.apmr.2006.11.002.
PubMed 17270511Sakai K, Nakayama E, Yoneoka D, Sakata N, Iijima K, Tanaka T, Hayashi K, Sakuma K, Hoshino E. Association of Oral Function and Dysphagia with Frailty and Sarcopenia in Community-Dwelling Older Adults: A Systematic Review and Meta-Analysis. Cells. 2022 Jul 14;11(14):2199. doi: 10.3390/cells11142199.
PubMed 35883642Kao SH, Chu H, Banda KJ, Sung CM, Chen R, Chang LF, Chiang KJ, Pien LC, Chou KR. Effects of Tongue Resistance and Strengthening Exercises on Tongue Strength and Oropharyngeal Swallowing in Frail Older Adults With Mild Cognitive Impairment: A Double-Blind Randomised Controlled Trial. J Oral Rehabil. 2026 Feb;53(2):402-414. doi: 10.1111/joor.70087. Epub 2025 Nov 5.
PubMed 41190776
Study at a glance
From the registry record, last updated by the sponsor on 8 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
- NCT06490705
- Acronym / sponsor ID
- ChangGungMF
- Conditions
- Dysphagia, Oropharyngeal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chang Gung Medical FoundationUniversity, hospital or other
- Collaborators
- Taipei Medical University
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 8 Jul 2024 (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 muscle strength and resistance exercises on dysphagia, tongue muscle strength, oral hygiene, repetitive saliva swallowing, nutrition, depression, and swallowing-related quality of life in frail elderly people with mild cognitive impairment in the community.
This is a longitudinal research design using cluster randomization. Participants were randomly divided into three groups by computer: Experimental Group 1 received tongue resistance exercises; Experimental Group 2 received both tongue strengthening exercises and tongue resistance exercises; and the control group received oral and cheek bulging exercises.
Detailed description
Recruitment was carried out in nursing homes, day passport centers, and community care centers in New Taipei City and Taoyuan City, Taiwan. The subjects were elderly people aged 65 years or older with cognitive impairment and frailty, recruited from November 19, 2021, to January 25, 2024.Participants were randomly divided into three groups by computer, 30 people per group, Group 1 received tongue resistance exercises, Group 2 received both tongue strengthening exercises and tongue resistance exercises, Group 3: control group received oral and cheek bulging exercises.
The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). Participants received exercise 6 days a week, 3 times a day (before meals), with each session lasting 30 minutes.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a longitudinal research design using cluster randomization. Participants were randomly divided into three groups by computer, 30 people per group: Group 1 received tongue resistance exercises. Group 2 received both tongue strengthening exercises and tongue resistance exercises. Group 3: control group received oral and cheek bulging exercises. The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). Participants received exercise 6 days a week, 3 times a day (before meals), with each session lasting 30 minutes.
| Arm | Type | Receives |
|---|---|---|
| Tongue resistance exercises | Experimental | Other: tongue resistance exercises, tongue strengthening exercises and tongue resistance exercisesParticipants received tongue resistance exercises 6 days a week, 3 times a day (before meals), with each session lasting 30 minutes. The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). |
| Tongue strengthening exercises and tongue resistance exercises | Experimental | Other: tongue resistance exercises, tongue strengthening exercises and tongue resistance exercisesParticipants received tongue strengthening exercises and tongue resistance exercises 6 days a week, 3 times a day (before meals), with each session lasting 30 minutes. The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). |
| cheek bulging exercises | Active comparator | Other: tongue resistance exercises, tongue strengthening exercises and tongue resistance exercisesParticipants received cheek bulging exercises6 days a week, 3 times a day (before meals), with each session lasting 30 minutes. The exercise intervention is divided into two stages. After completing the pre-test (T1), the first stage of 12 weeks of exercise begins, with evaluations conducted at the 4th week (T2), 8th week (T3), and 12th week (T4). After a 12-week rest period (T5), the second phase of Boosters exercise is conducted for another 12 weeks, followed by an immediate post-test (T6) and a final evaluation after another 12 weeks of rest (T7). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- A. Elderly individuals aged 65 years and above.
- B. Frailty assessment in older adults: Score of at least 1 point.
- C. Cognitive function assessment: Score of >=16 for individuals with no education; >=20 for those with elementary education; >=24 for those with junior high school education or higher.
Key exclusion criteria (7 listed)
- A. Severe communication barrier.
- B. Unable to move independently or requires assistance.
- C. Unable to raise head or neck.
- D. Recent use of anticholinergic medications, asthma medications, or central nervous system depressants (Benzodiazepines).
- E. Aspiration pneumonia.
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 exercises, tongue strengthening exercises and tongue resistance exercisesAlso: cheek bulging exercises6 days a week, 3 times a day (before meals), with each session lasting 30 minutes. Don't hold your breath during exercise. 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 at which the work was conducted and this study was approved by the Institutional Review Board. | Other | Tongue resistance exercises, Tongue strengthening exercises and tongue resistance exercises, cheek bulging exercises |
Primary outcome
Frailty assessment
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Based on the Fried 2001 frailty assessment scale, there are 5 items. The assessment takes only 3 minutes and uses a scoring system of 0 and 1. The possible total score ranges from 0 to 5 points, with higher scores indicating a more severe tendency towards frailty.
Activities of Daily Living (ADL)
Time frame: OT1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
The Activities of Daily Living (ADL) Assessment Scale consists of 10 items: eating, transferring, personal hygiene, toileting, bathing, walking on flat ground, climbing stairs, dressing and undressing, bowel control, and bladder control. Each item is graded on a scale of 2-4, ranging from complete dependence to complete independence, with scores incrementing by 5 points. The total score is out of 100 points. Scores from 0 to 20 indicate complete dependence; scores from 21 to 60 indicate severe dependence; scores from 61 to 90 indicate moderate dependence.
Instrumental Activities of Daily Living (IADLs)
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
The Instrumental Activities of Daily Living (IADL) Assessment consists of 8 items, each scored dichotomously (1 or 0), with a maximum total score of 8 points. The number of lost functions helps differentiate the severity of functional impairment, with higher scores indicating greater independence in older adults. The assessment is based on performance over the past month, obtained through observation, interviews with the individual, caregivers, or institutional records. The maximum score is 8 points; for male subjects, cooking, laundry, and housekeeping are not assessed, reducing the total score to 5 points. Mild disability is defined as needing assistance in three or more of the following five areas: shopping, going out, cooking, housekeeping, and laundry.
Mini-Mental State Examination (MMSE)
Time frame: Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
The Mini-Mental State Examination (MMSE) evaluates cognitive functions across five domains: orientation, registration, attention and calculation, short-term memory, language comprehension, spatial awareness, and ability to perform tasks. The assessment typically takes 5 to 10 minutes to administer. The maximum score is 30 points, with higher scores indicating better cognitive abilities. Each correct answer earns one point. A total score of <= 24 indicates mild cognitive impairment, while a score below 16 indicates severe cognitive impairment (Bleecker, Bolla-Wilson, Kawas, \& Agnew, 1988). However, these cutoffs should be adjusted according to educational level: for individuals with elementary education or less, <= 20 indicates mild cognitive impairment, and <= 16 indicates severe cognitive impairment.
Geriatric depression assessment (GDS)
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
The Geriatric Depression Scale assesses 15 items reflecting the individual's condition over the past week. Points are assigned as follows: Questions 1, 5, 7, 11, and 13 score 1 point if answered "No"; Questions 2, 3, 4, 6, 8, 9, 10, 12, 14, and 15 score 1 point if answered "Yes". Data is obtained through observation, interviews with the individual or caregivers. The total score ranges from 0 to 15 points. Cutoff points: Scores of 0-4 indicate good mental and emotional adaptation. Scores of 5-9 suggest mild depressive tendencies, recommending psychological counseling or professional consultation. Scores of 10-15 indicate more severe depressive tendencies, recommending referral to psychiatric treatment or professional counseling.
Functional oral intake assessment (FOIS)
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
The Functional Oral Intake Assessment consists of 7 items used to evaluate and observe how individuals consume food and liquids orally, categorized into stages 1-7. Stage 1 indicates no oral intake, while stage 7 indicates unrestricted oral intake with no limitations. The assessment is based on observing the individual's eating and swallowing abilities or reviewing institutional dietary records. Cutoff points: Stages 1-3 indicate dependence on tube feeding, while stages 4-7 indicate full oral intake.
Difficulty of mouth process (DOMP)
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
The Swallowing Difficulty Index is used to observe the severity of swallowing difficulties in study subjects, categorized into 0-4 stages. Stage 0 indicates severe difficulty, with significant oral residue, food scattered to the cheeks and beside the tongue, and frequent drooling. Stage 2 indicates moderate severity, with slow eating speed, poor water flow dynamics, some residue beside the tongue, and possible drooling. Stage 3 indicates mild severity, with slightly slower eating speed, slightly open lips, and occasional drooling. Stage 4 indicates normal swallowing function.
Oral health assessment tool (OHAT)
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
The Oral Health Assessment Scale consists of 8 assessment items: lips, tongue, gums, toothache, saliva, teeth, dentures, and oral hygiene. Each item is scored from 0 to 2 points, where 0 points indicate health and 2 points indicate poor health. Higher scores indicate worse oral health. Data is collected by assessing the individual's oral condition or checking institutional records. Score calculation: Scores range from 0 to 16 points, with higher scores indicating poorer oral health.
Swallowing-related quality of life assessment (SWQOL)
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
The Swallowing Quality of Life Questionnaire consists of 9 assessment items totaling 40 questions and 5 situational inquiries. It assesses the individual's experiences over the past month, their perception of their swallowing ability, and their sensations during swallowing. Scoring criteria: Items 1-9 (total of 40 questions) are scored on a 5-point Likert scale: "Always" scores 1 point (90-100% frequency/intensity), "Often" scores 2 points (60-80% frequency/intensity), "Sometimes" scores 3 points (30-50% frequency/intensity), "Rarely" scores 4 points (10-20% frequency/intensity), and "Never" scores 5 points (0% frequency/intensity). Questions 10-14 are supplemented by situational inquiries.Score calculation: Scores range from 40 to 200 points, with higher scores indicating better daily functioning and better quality of life.
Iowa Oral Performance Instrument (IOPI)
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
IOPI was used to measure tongue strength, tongue endurance, tongue endurance time, saliva swallowing pressure, effortful saliva swallowing pressure, and the strength of the left and right lips.
Mini-nutrition assessment(MNA)
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
To assess the nutritional status of elderly individuals, the scale consists of a total of 18 items divided into nutritional screening (total score of 14 points) and general assessment (total score of 16 points), resulting in a maximum total score of 30 points. Each item is graded according to its scoring level. If the nutritional screening score is 11 or less, further nutritional assessment is required, completing questions G-R to determine the "malnutrition indicator value." Nutritional assessment: Complete assessments for questions G-R, incorporate them into the total assessment score, and determine the "malnutrition indicator value." Cutoff points: 24 to 30 points = normal nutritional status; 17 to 23.5 points = at risk of malnutrition; less than 17 points = malnourished.
Repetitive saliva swallowing test (RSST)
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
The repetitive saliva swallowing test measures the number of rapid swallows in 30 seconds. The difficulty swallowing index during the pharyngeal phase will be used to observe the number of times the individual swallows saliva in 30 seconds, with a total of 3 assessment items. 1 point is scored if it does not reach three times, and 0 points are scored if the sensation of swallowing motion cannot be felt on the Adam's apple. The cutoff points are as follows: a score of 1 or below indicates a high-risk group for chewing and swallowing disorders, while a score of 2 indicates normal swallowing function.
Aspiration assessment
Time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
To obtain information for each option, use the aspiration assessment form to interview the case or caregiver, or check the institution's records: whether there has been a physician-diagnosed pneumonia, fever ≥ 38℃, respiratory symptoms like coughing or difficulty breathing, and 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 8 Jan 2025.
- Results publication: PubMed 28866854Jones E, Speyer R, Kertscher B, Denman D, Swan K, Cordier R. Health-Related Quality of Life and Oropharyngeal Dysphagia: A Systematic Review. Dysphagia. 2018 Apr;33(2):141-172. doi: 10.1007/s00455-017-9844-9. Epub 2017 Sep 2.
- Results publication: PubMed 12802092Lazarus C, Logemann JA, Huang CF, Rademaker AW. Effects of two types of tongue strengthening exercises in young normals. Folia Phoniatr Logop. 2003 Jul-Aug;55(4):199-205. doi: 10.1159/000071019.
- Results publication: PubMed 5349366Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
- Results publication: PubMed 27318884Park T, Kim Y. Effects of tongue pressing effortful swallow in older healthy individuals. Arch Gerontol Geriatr. 2016 Sep-Oct;66:127-33. doi: 10.1016/j.archger.2016.05.009. Epub 2016 Jun 3.
- Results publication: PubMed 36207669Rech RS, de Goulart BNG, Dos Santos KW, Marcolino MAZ, Hilgert JB. Frequency and associated factors for swallowing impairment in community-dwelling older persons: a systematic review and meta-analysis. Aging Clin Exp Res. 2022 Dec;34(12):2945-2961. doi: 10.1007/s40520-022-02258-x. Epub 2022 Oct 7.
- Results publication: PubMed 17270511Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8. doi: 10.1016/j.apmr.2006.11.002.
- Results publication: PubMed 35883642Sakai K, Nakayama E, Yoneoka D, Sakata N, Iijima K, Tanaka T, Hayashi K, Sakuma K, Hoshino E. Association of Oral Function and Dysphagia with Frailty and Sarcopenia in Community-Dwelling Older Adults: A Systematic Review and Meta-Analysis. Cells. 2022 Jul 14;11(14):2199. doi: 10.3390/cells11142199.
- Derived from this study: PubMed 41190776Kao SH, Chu H, Banda KJ, Sung CM, Chen R, Chang LF, Chiang KJ, Pien LC, Chou KR. Effects of Tongue Resistance and Strengthening Exercises on Tongue Strength and Oropharyngeal Swallowing in Frail Older Adults With Mild Cognitive Impairment: A Double-Blind Randomised Controlled Trial. J Oral Rehabil. 2026 Feb;53(2):402-414. doi: 10.1111/joor.70087. Epub 2025 Nov 5.
- Individual participant dataSharing planned: No. There are currently no plans to make individual participant data (IPD) available to other researchers.
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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 Memorial Hospital at Linkou, Taipei Medical University, Taipei, 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, tongue strengthening exercises and tongue resistance exercises in people with Dysphagia, Oropharyngeal, 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 3 inclusion and 7 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 8 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. 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?
Frailty assessment (time frame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.). The study lists 13 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 NCT06490705, which also lists 8 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 8 Jan 2025.