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

NCT ID: NCT07080996

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2026-03-24

Brief Summary

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.

Conditions

Presbyphagia; Abnormal Tongue Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Strengthening training group

Participants trained their tongue strength three times a week for four weeks.

Group Type: EXPERIMENTAL

Strengthening training with biofeedback

Intervention Type: 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 group

Participants trained their tongue endurance three times a week for four weeks.

Group Type: ACTIVE_COMPARATOR

Endurance training with biofeedback

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Surachart Thongchoomsin

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, Thailand

Countries

Thailand

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Other Identifiers

MU-CIRB 2025/037.2201

Identifier Type: -

Identifier Source: org_study_id