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

NCT06766487 | Completed DMC

• 2 other identifiers: N202001044CMRPG5L0032
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Tongue Resistance Exercises; Frail; Swallowing Function

Outcome Measures

Primary Outcomes (4)

• Tongue strength (anterior tongue strength [ATS] and posterior tongue strength [PTS])

  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.

  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 (anterior tongue endurance [ATE] and posterior tongue endurance [PTE])

  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%).

  Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).

• Swallowing pressure (saliva swallowing pressure [SSP] and effortful swallow pressure [ESP]).

  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.

  Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).

• Aspiration assessment

  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.

  Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).

Study Arms (2)

Tongue Resistance Exercises

EXPERIMENTAL

TRTP involved movements of the tongue's anterior, middle, posterior, and lateral parts, targeting the intrinsic and extrinsic tongue muscles and the soft palate.

Behavioral: Tongue resistance exercises

cheek bulging exercises

PLACEBO COMPARATOR

Cheek bulging exercises involved closing the lips, bulging the right cheek, relaxing and returning to the initial position, bulging the left cheek, relaxing and returning to the initial position, and finally bulging both cheeks simultaneously.

Behavioral: cheek bulging exercises

Interventions

Tongue resistance exercises BEHAVIORAL

The 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.

Tongue Resistance Exercises

cheek bulging exercises BEHAVIORAL

Cheek 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.

cheek bulging exercises

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Having aspiration pneumonia
• Tracheotomy is retained

Sponsors & Collaborators

• Chang Gung Medical Foundation: lead
• Taipei Medical University: collaborator

Study Sites (1)

Chang Gung Memorial Hospital at Linkou

Taoyuan District, Taiwan, 333, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 36906939 BACKGROUND

• 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.

  PMID: 30962680 BACKGROUND

• 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.

  PMID: 27883209 BACKGROUND

• Kao SH, Chen R, Su PY, Banda KJ, Sung CM, Wang CH, Chiang KJ, Fajarini M, Chou KR. A tongue resistance training program improves strength, endurance, and swallowing in frail older adults with mild cognitive impairment: a double-blind randomized controlled trial. Geroscience. 2025 May 29. doi: 10.1007/s11357-025-01715-5. Online ahead of print.

  PMID: 40439971 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kao S Hua, Master

  Chang Gung Medical Foundation Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This study employed a prospective, double-blind, randomized controlled trial design to investigate the effects of TREs in frail older adults with MCI. Potential participants from nursing homes and community-based daytime long-term care centers underwent eligibility screening. To ensure blinding, a research assistant not directly involved in the study conducted random sequence generation for group allocation using an online computer-based randomization program. Block randomization (1:1 ratio) was implemented to maintain equal group sizes. The research assistant then sealed the group allocation data in opaque envelopes, which were stored securely in a locked cabinet. Both participants and researchers were blinded to group assignment. Participants remained unaware of their assigned intervention (TREs or cheek-bulging exercises), and researchers were also blinded to participant group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chang Gung Medical Foundation

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: August 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: January 9, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)