Chang Gung Memorial Hospital At Linkou
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Tongue strength (anterior tongue strength [ATS] and posterior tongue strength [PTS])
研究概览
简要总结
The purpose of this study is to explore the effects of tongue resistance exercises on tongue muscle strength and swallowing function in frail older adults with mild cognitive impairment living in the community.
This study adopts a longitudinal research design with randomization. Participants were randomly assigned to two groups using an online computer-based randomization tool. The experimental group performed tongue resistance exercises, while the control group practiced cheek bulging exercises.
详细描述
Recruitment took place in nursing homes, day care centers, and community care centers across Taiwan. Participants were older adults aged 65 years or older with mild cognitive impairment and frailty, enrolled between August 1, 2021, and July 31, 2022.
Participants were randomly divided into two groups by computer, 23 peoples per group, The experimental group performed tongue resistance exercises, while the control group practiced cheek bulging exercises. The exercise intervention is 12 weeks of exercise begins, with each session 30 minutes.
The evaluation items include basic information, outcomes collected through a Iowa Oral Performance Instrument (IOPI) was used to measure tongue strength, tongue endurance, tongue endurance time, saliva swallowing pressure, effortful saliva swallowing pressure, and Aspiration assessment. The measurement times are as follows: T0 (Baseline), T1 (Week 4, Mid-Intervention), T2 (Immediate Post-Test after the 12-Week Intervention), and T3 (Follow-Up after the 12-Week Intervention).
Before conducting the study, all participants received a complete explanation of the purpose, risks, and procedures of the investigation, and provided written informed consent. Procedures were in accordance with the ethical standards of the committee on human experimentation at the institution where the work was conducted, and this study was approved by the Institutional Review Board.
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, Care Provider)
盲法说明
This study employed a prospective, double-blind, randomized controlled trial design to investigate the effects of TREs in frail older adults with MCI. Potential participants from nursing homes and community-based daytime long-term care centers underwent eligibility screening. To ensure blinding, a research assistant not directly involved in the study conducted random sequence generation for group allocation using an online computer-based randomization program. Block randomization (1:1 ratio) was implemented to maintain equal group sizes. The research assistant then sealed the group allocation data in opaque envelopes, which were stored securely in a locked cabinet. Both participants and researchers were blinded to group assignment. Participants remained unaware of their assigned intervention (TREs or cheek-bulging exercises), and researchers were also blinded to participant group allocation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild cognitive impairment in older adults aged ≥65 years
- •Frailty assessment: at least 1 point
排除标准
- •Having aspiration pneumonia
- •Tracheotomy is retained
结局指标
主要结局
Tongue strength (anterior tongue strength [ATS] and posterior tongue strength [PTS])
时间窗: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Tongue strength was measured using IOPI (Model 3.1) device, which was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition . The bulb was placed on the palate inside the upper front teeth and at the junction of the hard palate and soft palate to measure ATS and PTS. Maximum isometric pressure (MIP) was defined as the pressure generated when the participant pushed the tongue forcefully against the palate and maintained it for 3 seconds for both the anterior and posterior tongue. Each exercise was performed thrice, with 1-minute intervals between trials. The highest value from the three trials was recorded. MIP is reported in terms of kilopascals. The average pressure values for the anterior and posterior parts of the tongue were 55.95 ± 14.13 kPa and 53.23 ± 12.24 kPa, respectively.
Tongue Endurance (anterior tongue endurance [ATE] and posterior tongue endurance [PTE])
时间窗: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Tongue endurance was measured using IOPI (Model 3.1) device using the target mode with the target value set at 50% of the individual's MIP. The bulb was placed on either the anterior tongue or the posterior tongue to measure ATE and PTE. The participant pushed the tongue against the palate for 3 seconds. If the pressure exceeded the target value, the instrument displayed a green light indicating the goal had been achieved. Tongue endurance was assessed only once. For the assessment of tongue endurance, interrater reliability was .97, and interrater reliability was .95. Tongue weakness, defined as a tongue pressure of \<30 kPa, is associated with a risk of malnutrition.At the indicated cutoff values, the assessment sensitivity was 92% (95% CI: 75% to 98%), specificity was 96% (95% CI: 87% to 99%), positive predictive value was 92% (95% CI: 75% to 98%), negative predictive value was 96% (95% CI: 87% to 99%), and accuracy was 94.7% (95% CI: 87% to 98%).
Swallowing pressure (saliva swallowing pressure [SSP] and effortful swallow pressure [ESP]).
时间窗: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
Saliva swallowing pressure (SSP) was measured using IOPI (Model 3.1). The IOPI device was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition. The bulb was placed on the palate inside the upper front teeth. The participant gently closed the mouth and then swallowed saliva normally (without pressing the bulb with the tongue). An SSP of \<10.3 kPa among older adults is associated with an increased risk of aspiration pneumonia.Effortful Swallowing Pressure (ESP) was measured using IOPI (Model 3.1). The IOPI device was set to record peak pressure and repeated strength to evaluate the maximum pressure exerted during each repetition. The bulb was placed on the palate inside the upper front teeth. The participant gently closed the mouth performed an effortful saliva swallow (eg, an egg), but did not press the bulb with the tongue.
Aspiration assessment
时间窗: Assessments were performed at baseline (T0), 4-week mid-intervention (T1), 12-week immediate post-intervention (T2), and 12-week follow-up (T3).
The references were developed using a structured evaluation form. Information for each option was obtained by interviewing the case or caregiver or by reviewing the institution's records. The evaluation included determining whether there had been a physician-diagnosed case of pneumonia, a fever ≥ 38℃, or respiratory symptoms such as coughing or difficulty breathing, as well as recording the dates of occurrence.
次要结局
未报告次要终点
研究者
Kao, Shu-Hua
Chang Gung Medical Foundation
Chang Gung Medical Foundation