Elucidating Factors Contributing to Dysphagia in Frail Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Score on Modified Barium Swallow Impairment Profile (MBSImP)
研究概览
简要总结
The purpose of this research study is to figure out if there are physical factors such as cognition level, nutrition status, walking speed, and handgrip strength that are associated with the development of swallowing problems. Investigators want to better understand how swallowing problems develop in older adults with and without frailty. Identifying factors that contribute to swallowing problems, can develop therapies in the future to improve swallowing outcomes for older adults.
This study will be done at the University of Wisconsin-Madison (UW-Madison). A total of about 69 people will participate in this study.
详细描述
This study has 3 specific aims:
Aim 1 will determine the presence and severity of dysphagia in a cohort of older adults based on clinical frailty phenotype; Aim 2 will examine the effects of frailty status on physiological measures of swallowing in older adults; and Aim 3 will characterize relationships among specific functional frailty domains and dysphagia status in older adults.
This proposed research will provide a new understanding of the factors that underlie and contribute to dysphagia across clinical frailty phenotypes. Equipped with this knowledge, future treatment and management approaches can be developed to proactively identify dysphagia risk factors in pre-frail and frail individuals so dysphagia can be prevented or adequately addressed. This work is highly significant due to the large and increasing population of aging people who often suffer from debilitating swallowing impairments and may benefit from optimized treatments that can be developed using knowledge gained from this study.
Per approved protocol amendment on 3/39/2022, saliva samples will be collected to explore the composition and structure of oral microbiota via 16S rRNA gene analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •65 years of age or older
- •Ability to provide informed consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient
- •Post-menopausal (female participants)
- •Not pregnant
排除标准
- •Allergy to barium
- •Prior surgery to the head and neck region affecting swallowing-related structures
- •Prior chemotherapy or radiation treatment to the head and neck region
- •Prior cerebral vascular accident with resulting persistent dysphagia
- •Non-English speaking
研究组 & 干预措施
Non-frail group
Participants will be assessed using five criteria from the Fried Frailty Index. Index scores"0" will place the participants in Non-frail group.
Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion.
Pre-frail group
Participants will be assessed using five criteria from the Fried Frailty Index. Index scores"1-2" will place the participants in Pre-frail group.
Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion.
Frail group
Participants will be assessed using five criteria from the Fried Frailty Index. Index scores"3-5" will place the participants in Frail group.
Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion.
结局指标
主要结局
Score on Modified Barium Swallow Impairment Profile (MBSImP)
时间窗: 2 weeks
Dysphagia presence and severity will be examined using the validated Modified Barium Swallow Impairment Profile (MBSImP). Under MBSImP, swallows are assessed via 17 physiologic components pertaining to the oral and pharyngeal phases of swallowing. These individual components are scored from '0' to '5' with higher scores representing greater (worse) impairment within each component. The MBSImP yields total composite scores for the oral and pharyngeal domains as well as an overall impression score which is the worst score across all 17 components.
次要结局
- Upper esophageal sphincter (UES) opening width (mm)(2 weeks)
- Gate analysis: cadence (steps per minute)(Day 0)
- Gate analysis: normalized base of support(Day 0)
- Gate analysis: normalized walking velocity(Day 0)
- Hyoid burst to upper esophageal sphincter open (ms)(2 weeks)
- Pharyngeal constriction ratio (PCR)(2 weeks)
- Lingual Pressure Outcome: Cycle duration(Day 0)
- Score on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale: Dysphagia severity(2 weeks)
- Laryngeal closure duration (ms).(2 weeks)
- Pharyngeal Pressure Outcome: Integral pressure (mmHg*time)(2 weeks)
- Lingual Pressure Outcome: Cyclic spatiotemporal index (CSTI)(Day 0)
- Respiratory Measurement: Peak Expiratory Flow (PEF)(Day 0)
- Swallowing reaction time (ms)(2 weeks)
- Upper esophageal sphincter opening duration (ms)(2 weeks)
- Number of participants assessed as pass/fail the three ounce water swallow test(2 weeks)
- Lingual Pressure Outcome: Saliva swallow pressure(Day 0)
- Respiratory Measurement: Maximum expiratory pressure(MEP)(Day 0)
- Respiratory Measurement: Maximum inspiratory pressure (MIP)(Day 0)
- Respiratory Measurement: FEV1/FVC Ratio(Day 0)
- Extensional viscosity of saliva(2 weeks)
- Time to break up saliva(ms)(2 weeks)
- Salivary pH(2 weeks)
- Number of participants with presence/absence of dysphagia based on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale(2 weeks)
- Laryngeal closure reaction time (ms)(2 weeks)
- Pixel-based measure of pharyngeal residue (%C2-C4 squared)(2 weeks)
- Masticatory efficiency evaluated by Test of Masticating and Swallowing Solids (TOMASS)(2 weeks)
- Pharyngeal Pressure Outcome: Pharyngeal contractile integral (PhCI)(2 weeks)
- Pharyngeal Pressure Outcome: Total swallow duration(2 weeks)
- Lingual Pressure Outcome: Mean slope (kpa/seconds)(Day 0)
- Respiratory Measurement: Maximum Forced vital capacity (FVC)(Day 0)
- Respiratory Measurement: Forced Expiratory Volume in 1 second (FEV1)(Day 0)
- Gate analysis: step extremity ratio(Day 0)
- Extent of hyoid movement (mm)(2 weeks)
- Lingual Pressure Outcome: Maximum lingual pressure(Day 0)
- Salivary flow rate (grams/minute)(2 weeks)
- Mini Nutritional Assessment Score(Day 0)
- Body Mass Index (BMI)(Day 0)
- Limb function outcome: average handgrip strength(Day 0)
- Gate analysis: percentage of the gait cycle spent in double support time(Day 0)
- Presence/absence of exhaustion(Day 0)
- Total physical activity measured as kilocalories expended per week(Day 0)
- Montreal Cognitive Assessment (MoCA) score(Day 0)