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Enrolling by invitation NCT07080996

Effect of Biofeedback Tongue Strengthening Program on Tongue Pressure and Swallowing Performance

Phase III Interventional Presbyphagia Abnormal Tongue Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Strengthening training with biofeedback, Endurance training with biofeedback.
Who it may be relevant to
Registry conditions: Presbyphagia, Abnormal Tongue Pressure. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Biofeedback Tongue Strengthening Program on Tongue Pressure and Swallowing Performance in Elderly With Abnormal Tongue Pressure

Overview

Aging is often accompanied by a decline in bodily functions, including the swallowing process. Tongue-strengthening exercises have been shown to improve tongue strength and thickness in healthy adults and the elderly, thereby supporting swallowing function. Consistent exercise is key to preventing muscle weakness and preserving their ability to swallow. However, there is limited research on the effects of tongue-strengthening exercises that explores varying intensities and repetitions in elderly with impaired tongue pressure. Consequently, the objective of this study is to investigate the effect of biofeedback tongue strengthening program on tongue pressure and swallowing performance in elderly with abnormal tongue pressure. The results will serve as valuable data for selecting effective interventions to improve tongue strength and swallowing.

Detailed description

Sample size calculation: A sample size of 52 participants was determined for this study, accounting for a 20% dropout rate. The calculation was performed using G\*Power software (version 3.1.7), based on an effect size of 0.87. This value was derived from a previous study by Van den Steen et al. (21), which measured the difference in mean tongue pressure strength between training and control groups. With an effect size of 0.87, considered a large effect, a minimum of 44 participants was required to achieve 80% statistical power at a significance level of 0.05. Statistical analysis: IBM SPSS Statistics will be used for all data analysis. A chi-squared test and Mann-Whitney U test will be performed to compare the baseline characteristics of participants between the two groups. A two-way ANOVA will be used to analyze differences between the two groups (strengthening training and endurance training) across the three time points (Baseline, Post-test after one day, and Post-test after one month). Subsequently, a Wilcoxon signed-rank test will be used to identify significant changes within each group at each time point.

Interventions

  • Combination product Strengthening training with biofeedback
    Participants in this group trained their tongue strength with the Iowa Oral Performance Instrument (IOPI), completing 3 sets of 10 repetitions at 80% of their maximum.
  • Combination product Endurance training with biofeedback
    Participants in this group trained their tongue endurance with the Iowa Oral Performance Instrument (IOPI), completing 3 sets of 20 repetitions at 60% of their maximum.

Primary outcome measures

  • Tongue pressure [Time frame: Baseline, Post-test after one day of training, Post-test after one month of training]
  • Eating Assessment Tool-10 (EAT-10) score [Time frame: Baseline, Post-test after one day of training, Post-test after one month of training]
  • Functional Oral Intake Scale (FOIS) [Time frame: Baseline, Post-test after one day of training, Post-test after one month of training]
  • Mann Assessment of Swallowing Ability (MASA) score [Time frame: Baseline, Post-test after one day of training, Post-test after one month of training]
  • Water swallowing test [Time frame: Baseline, Post-test after one day of training, Post-test after one month of training]

Eligibility criteria

Inclusion criteria

  • Aged 60 years or older.
  • No cognitive impairment, as screened by the Mini-Mental State Examination (MMSE) with a score of 24 or higher.
  • Elderly with abnormal tongue pressure have an anterior maximum isometric tongue pressure (MIP) average of less than 30 kilopascals.

Exclusion criteria

  • Diagnosed with head and neck cancers, a neurological disorder, or other conditions that affect the tongue muscle strength and training.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Faculty of Physical Therapy, Mahidol University — Salaya

Publications

  • Nakao Y, Yamashita T, Honda K, Katsuura T, Hama Y, Nakamura Y, Ando K, Ishikura R, Kodama N, Uchiyama Y, Domen K. Association Among Age-Related Tongue Muscle Abnormality, Tongue Pressure, and Presbyphagia: A 3D MRI Study. Dysphagia. 2021 Jun;36(3):483-491. doi: 10.1007/s00455-020-10165-4. Epub 2020 Aug 2. PMID 32743742
  • Hsiao HL, Lou JH, Wang CC, Lai YJ, Wu SJ, Hwu YJ. Effects of Tongue-Strengthening Exercise on Tongue Strength Reserve and Detraining Effects among Healthy Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jun 4;19(11):6878. doi: 10.3390/ijerph19116878. PMID 35682461
  • Feng HY, Zhang PP, Wang XW. Presbyphagia: Dysphagia in the elderly. World J Clin Cases. 2023 Apr 16;11(11):2363-2373. doi: 10.12998/wjcc.v11.i11.2363. PMID 37123321
  • Sarve AR, Krishnamurthy R, Balasubramanium RK. The timed water test of swallowing: Reliability, validity, and normative data from Indian population. Int J Health Sci (Qassim). 2021 Mar-Apr;15(2):14-20. PMID 33708040
  • Park HJ, Jung EH, Kim SM, Park SC, Jo MJ, Lee YS, Kim SH, Han SY. Assessment of oral hypofunction and its association with age among Korean community-dwelling older adults. BMC Oral Health. 2024 Apr 10;24(1):441. doi: 10.1186/s12903-024-04180-2. PMID 38600517
  • Yano J, Nagami S, Yokoyama T, Nakamura K, Kobayashi M, Odan Y, Hikasa M, Hanayama K, Fukunaga S. Effects of Tongue-Strengthening Self-Exercises in Healthy Older Adults: A Non-Randomized Controlled Trial. Dysphagia. 2021 Oct;36(5):925-935. doi: 10.1007/s00455-020-10216-w. Epub 2020 Nov 19. PMID 33215265
  • Sakamoto Y, Oyama G, Umeda M, Funahara M, Soutome S, Nakamura W, Kojima Y, Iwai H. Effect of decreased tongue pressure on dysphagia and survival rate in elderly people requiring long-term care. J Dent Sci. 2022 Apr;17(2):856-862. doi: 10.1016/j.jds.2021.09.031. Epub 2021 Oct 7. PMID 35756815
  • Fei T, Polacco RC, Hori SE, Molfenter SM, Peladeau-Pigeon M, Tsang C, Steele CM. Age-related differences in tongue-palate pressures for strength and swallowing tasks. Dysphagia. 2013 Dec;28(4):575-81. doi: 10.1007/s00455-013-9469-6. Epub 2013 May 16. PMID 23677389

Identifiers

NCT: NCT07080996 · MU-CIRB 2025/037.2201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗