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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strengthening training group | Experimental | Participants trained their tongue strength three times a week for four weeks. |
|
| Endurance training group | Active Comparator | Participants trained their tongue endurance three times a week for four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy, Mahidol University | Salaya | Changwat Nakhon Pathom | 73170 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32743742 | Background | 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. | |
| 35682461 | Background |
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We will share IPD when we receive the consent from participants.
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D000076663 | Endurance Training |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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All participants are randomly assigned to either the strengthening training or endurance training group using a computer.
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This research is a double-blind study, in which both participants and the assessor are blinded to the group assignments.
| 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. |
|
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| D010038 | Otorhinolaryngologic Diseases |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |