Clinical trial NCT06490705: The Efficacy of Tongue Exercises on Swallowing Function in the Elderly with Mild Cognitive Impairment
Official title: Chang Gung Memorial Hospital At Linkou
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia, Oropharyngeal
Lead sponsor: Chang Gung Medical Foundation
Sponsor class: OTHER
Collaborators: name: Taipei Medical University
First posted: 2024-07-08
Enrollment: 88
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frailty assessment
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Activities of Daily Living (ADL)
timeFrame: OT1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Instrumental Activities of Daily Living (IADLs)
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Mini-Mental State Examination (MMSE)
timeFrame: Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Geriatric depression assessment (GDS)
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Functional oral intake assessment (FOIS)
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Difficulty of mouth process (DOMP)
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Oral health assessment tool (OHAT)
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Swallowing-related quality of life assessment (SWQOL)
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Iowa Oral Performance Instrument (IOPI)
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Mini-nutrition assessment(MNA)
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Repetitive saliva swallowing test (RSST)
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
measure: Aspiration assessment
timeFrame: T1 baseline; Outcomes were measured 6 times, T2~T7 were conducted at 4.8.12.24.36.48 weeks after exercise.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital at Linkou
Study officials:
affiliation: Chang Gung Memorial Hospital at Linkou, Taipei Medical University, Taipei, Taiwan
name: Kao S Hua, Master
role: STUDY_CHAIR
References:
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