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

C

Chang Gung Medical Foundation

Status

Completed

Conditions

Dysphagia, Oropharyngeal

Treatments

Other: tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT06490705
ChangGungMF

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

88 participants in 3 patient groups

Tongue resistance exercises
Experimental group
Description:
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).
Treatment:
Other: tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises
Tongue strengthening exercises and tongue resistance exercises
Experimental group
Description:
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).
Treatment:
Other: tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises
cheek bulging exercises
Active Comparator group
Description:
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).
Treatment:
Other: tongue resistance exercises, tongue strengthening exercises and tongue resistance exercises

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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