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NCT Number: NCT07080996

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

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.

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Key information

Conditions

Presbyphagia Abnormal Tongue Pressure Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Strengthening training with biofeedback

Combination Product

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.

Endurance training with biofeedback

Combination Product

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 outcomes

  1. Tongue pressure

    Time frame: Baseline, Post-test after one day of training, Post-test after one month of training

    The Iowa Oral Performance Instrument (IOPI Medical LCC, Redmond, WA USA) was used to measure maximum anterior and posterior tongue pressure, as well as tongue pressure during swallowing.

  2. Eating Assessment Tool-10 (EAT-10) score

    Time frame: Baseline, Post-test after one day of training, Post-test after one month of training

    The EAT-10 is used to assess swallowing difficulties. The 10 items are scored from 0 to 4, with higher scores indicating more severe dysphagia.

  3. Functional Oral Intake Scale (FOIS)

    Time frame: Baseline, Post-test after one day of training, Post-test after one month of training

    The FOIS is a 7-point ordinal scale describing the functional level of oral intake of food and liquids.

  4. Mann Assessment of Swallowing Ability (MASA) score

    Time frame: Baseline, Post-test after one day of training, Post-test after one month of training

    The MASA is a standardized clinical swallowing examination, specifically developed as a diagnostic test for the presence of oropharyngeal dysphagia. The total score of the MASA is 200 points and the cutoff value is 177 points. The results of the MASA are interpreted as no abnormality (≥178), mild dysphagia (168-177), moderate dysphagia (139-167), and severe dysphagia (≤138).

  5. Water swallowing test

    Time frame: Baseline, Post-test after one day of training, Post-test after one month of training

    The Water Swallow Test is a clinical instrument designed to assess swallowing function. A participant is seated and provided with a cup containing 150 mL of water at a standard temperature. The total time required to ingest the liquid is then recorded.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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