Effect of Biofeedback Tongue Strengthening Program on Tongue Pressure and Swallowing Performance in Elderly With Abnormal Tongue Pressure
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Tongue pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This research is a double-blind study, in which both participants and the assessor are blinded to the group assignments.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Diagnosed with head and neck cancers, a neurological disorder, or other conditions that affect the tongue muscle strength and training.
研究组 & 干预措施
Strengthening training group
Participants trained their tongue strength three times a week for four weeks.
干预措施: Strengthening training with biofeedback (Combination Product)
Endurance training group
Participants trained their tongue endurance three times a week for four weeks.
干预措施: Endurance training with biofeedback (Combination Product)
结局指标
主要结局
Tongue pressure
时间窗: 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.
Mann Assessment of Swallowing Ability (MASA) score
时间窗: 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).
Water swallowing test
时间窗: 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.
Eating Assessment Tool-10 (EAT-10) score
时间窗: 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.
Functional Oral Intake Scale (FOIS)
时间窗: 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.
次要结局
未报告次要终点
研究者
Surachart Thongchoomsin
Lecturer
Mahidol University