Clinical Trials Directory

Trials / Completed

CompletedNCT06766487

Effectiveness of Tongue Resistance Exercises on Tongue and Swallowing Function in Frail Older Adults With MCI

Chang Gung Memorial Hospital at Linkou

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Chang Gung Medical Foundation · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTongue resistance exercisesThe TRE program consisted of the following exercises: Exercise 1: Tongue Protrusion and Retraction Against Resistance, Exercise 2: Anterior Tongue Protrusion and Retraction Against Resistance, Exercise 3: Middle Tongue Protrusion and Retraction Against Resistance, Exercise 4: Middle Tongue Elevation with Pharyngeal Sound Production, Exercise 5: Tongue Elevation and Posterior Sweeping, and Exercise 6: Saliva Swallowing with Lip Closure.
BEHAVIORALcheek bulging exercisesCheek bulging exercises involved a series of movements: Lip Closure: Participants began by closing their lips. Unilateral Cheek Bulging: They then bulged their right cheek, followed by relaxation and return to the initial position. This was repeated on the left side. Bilateral Cheek Bulging: Finally, participants bulged both cheeks simultaneously.

Timeline

Start date
2021-08-01
Primary completion
2022-07-31
Completion
2022-07-31
First posted
2025-01-09
Last updated
2025-01-09

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT06766487. Inclusion in this directory is not an endorsement.