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

NCT07080996 | Enrolling By Invitation Phase 3

• 1 other identifier: MU-CIRB 2025/037.2201
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyphagia; Abnormal Tongue Pressure

Keywords

Elderly; Presbyphagia; Dysphagia; Tongue Pressure; Biofeedback

Outcome Measures

Primary Outcomes (5)

• Tongue pressure

  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.

  Baseline, Post-test after one day of training, Post-test after one month of training

• Eating Assessment Tool-10 (EAT-10) score

  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.

  Baseline, Post-test after one day of training, Post-test after one month of training

• Functional Oral Intake Scale (FOIS)

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

  Baseline, Post-test after one day of training, Post-test after one month of training

• Mann Assessment of Swallowing Ability (MASA) score

  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).

  Baseline, Post-test after one day of training, Post-test after one month of training

• Water swallowing test

  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.

  Baseline, Post-test after one day of training, Post-test after one month of training

Study Arms (2)

Strengthening training group

EXPERIMENTAL

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

Combination Product: Strengthening training with biofeedback

Endurance training group

ACTIVE COMPARATOR

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

Combination Product: Endurance training with biofeedback

Interventions

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.

Strengthening training group

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.

Endurance training group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

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MeSH Terms

Conditions

Deglutition Disorders

Interventions

Biofeedback, Psychology; Endurance Training

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This research is a double-blind study, in which both participants and the assessor are blinded to the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: All participants are randomly assigned to either the strengthening training or endurance training group using a computer.

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: March 25, 2025
• Primary Completion: February 24, 2026
• Study Completion: March 24, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

TH (1)