Clinical trial NCT06766487: Effectiveness of Tongue Resistance Exercises on Tongue and Swallowing Function in Frail Older Adults with MCI
Official title: Chang Gung Memorial Hospital At Linkou
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Tongue Resistance Exercises
Frail
Swallowing Function
Lead sponsor: Chang Gung Medical Foundation
Sponsor class: OTHER
Collaborators: name: Taipei Medical University
First posted: 2025-01-09
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Mild cognitive impairment in older adults aged ≥65 years
* Frailty assessment: at least 1 point

Exclusion Criteria:

* Having aspiration pneumonia
* Tracheotomy is retained

Primary outcomes:
measure: Tongue strength (anterior tongue strength [ATS] and posterior tongue strength [PTS])
timeFrame: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
measure: Tongue Endurance (anterior tongue endurance [ATE] and posterior tongue endurance [PTE])
timeFrame: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
measure: Swallowing pressure (saliva swallowing pressure [SSP] and effortful swallow pressure [ESP]).
timeFrame: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
measure: Aspiration assessment
timeFrame: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital at Linkou
Study officials:
affiliation: Chang Gung Medical Foundation Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan
name: Kao S Hua, Master
role: STUDY_CHAIR
References:
citation: 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.
citation: Namiki 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.
citation: Kim 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.