The Efficacy of Tongue Exercises on Swallowing Function in the Elderly with Mild Cognitive Impairment

NCT ID: NCT06490705

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-19

Study Completion Date

2024-01-25

Brief Summary

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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

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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

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Dysphagia, Oropharyngeal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
The study design uses cluster randomization to assign subjects to three groups different exercise groups. This study employs a single-blind design to minimize bias, where the participants are blinded to the group allocations.

Study Groups

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Tongue resistance exercises

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).

Group Type EXPERIMENTAL

tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises

Intervention Type OTHER

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.

Tongue strengthening exercises and tongue resistance exercises

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).

Group Type EXPERIMENTAL

tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises

Intervention Type OTHER

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.

cheek bulging exercises

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).

Group Type ACTIVE_COMPARATOR

tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises

Intervention Type OTHER

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.

Interventions

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tongue resistance exercises, tongue strengthening exercises and tongue resistance 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.

Intervention Type OTHER

Other Intervention Names

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cheek bulging exercises

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role collaborator

Chang Gung Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Kao, Shu-Hua

Chang Gung Memorial Hospital at Linkou

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kao S Hua, Master

Role: STUDY_CHAIR

Chang Gung Memorial Hospital at Linkou, Taipei Medical University, Taipei, Taiwan

Locations

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Chang Gung Memorial Hospital at Linkou

Taoyuan, Taoyuan City, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 28866854 (View on PubMed)

Lazarus 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.

Reference Type BACKGROUND
PMID: 12802092 (View on PubMed)

Lawton 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.

Reference Type BACKGROUND
PMID: 5349366 (View on PubMed)

Park 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.

Reference Type BACKGROUND
PMID: 27318884 (View on PubMed)

Rech 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.

Reference Type BACKGROUND
PMID: 36207669 (View on PubMed)

Robbins 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.

Reference Type BACKGROUND
PMID: 17270511 (View on PubMed)

Sakai 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.

Reference Type BACKGROUND
PMID: 35883642 (View on PubMed)

Other Identifiers

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ChangGungMF

Identifier Type: -

Identifier Source: org_study_id

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