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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT06766487
• Lead Sponsor: Chang Gung Medical Foundation

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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-06
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-04
• Last Update Submitted: 2025-01-04
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tongue strength (anterior tongue strength [ATS] and posterior tongue strength [PTS])	Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).	Tongue strength was measured using IOPI (Model 3.1) device, which was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition . The bulb was placed on the palate inside the upper front teeth and at the junction of the hard palate and soft palate to measure ATS and PTS. Maximum isometric pressure (MIP) was defined as the pressure generated when the participant pushed the tongue forcefully against the palate and maintained it for 3 seconds for both the anterior and posterior tongue. Each exercise was performed thrice, with 1-minute intervals between trials. The highest value from the three trials was recorded. MIP is reported in terms of kilopascals. The average pressure values for the anterior and posterior parts of the tongue were 55.95 ± 14.13 kPa and 53.23 ± 12.24 kPa, respectively.
Tongue Endurance (anterior tongue endurance [ATE] and posterior tongue endurance [PTE])	Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).	Tongue endurance was measured using IOPI (Model 3.1) device using the target mode with the target value set at 50% of the individual's MIP. The bulb was placed on either the anterior tongue or the posterior tongue to measure ATE and PTE. The participant pushed the tongue against the palate for 3 seconds. If the pressure exceeded the target value, the instrument displayed a green light indicating the goal had been achieved. Tongue endurance was assessed only once. For the assessment of tongue endurance, interrater reliability was .97, and interrater reliability was .95. Tongue weakness, defined as a tongue pressure of \<30 kPa, is associated with a risk of malnutrition.At the indicated cutoff values, the assessment sensitivity was 92% (95% CI: 75% to 98%), specificity was 96% (95% CI: 87% to 99%), positive predictive value was 92% (95% CI: 75% to 98%), negative predictive value was 96% (95% CI: 87% to 99%), and accuracy was 94.7% (95% CI: 87% to 98%).
Swallowing pressure (saliva swallowing pressure [SSP] and effortful swallow pressure [ESP]).	Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).	Saliva swallowing pressure (SSP) was measured using IOPI (Model 3.1). The IOPI device was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition. The bulb was placed on the palate inside the upper front teeth. The participant gently closed the mouth and then swallowed saliva normally (without pressing the bulb with the tongue). An SSP of \<10.3 kPa among older adults is associated with an increased risk of aspiration pneumonia.Effortful Swallowing Pressure (ESP) was measured using IOPI (Model 3.1). The IOPI device was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition. The bulb was placed on the palate inside the upper front teeth. The participant gently closed the mouth performed an effortful saliva swallow (eg, an egg), but did not press the bulb with the tongue.
Aspiration assessment	Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).	The references were developed using a structured evaluation form. Information for each option was obtained by interviewing the case or caregiver or by reviewing the institution's records. The evaluation included determining whether there had been a physician-diagnosed case of pneumonia, a fever ≥ 38℃, or respiratory symptoms such as coughing or difficulty breathing, as well as recording the dates of occurrence.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital at Linkou; 🇨🇳 Taoyuan, Taiwan