Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Measurement of pharyngeal constriction before intervention
研究概览
简要总结
The purpose of this study is to learn more about how exercise and protein supply affect swallow muscles. Twenty healthy older adults will be recruited from local community centers, physician offices, and retirement communities via flyers. Participants will complete 16 sessions of standard of care swallowing exercises 2 times per week for 8 weeks. All sessions will be conducted via Zoom. During each session, a series of swallow exercises will be performed following a demonstration from a trained speech-language pathologist. Participants will be referred to NYU Langone Health or White Plains Hospital, for a videofluoroscopic swallowing study, acoustic pharyngometry and measures of hand grip strength before and after the treatment protocol. Patients will be able to select their preferred site for swallow study completion. Results will inform the relationship between swallow exercises and pharyngeal muscles. All devices and exercises are established as safe and effective and are FDA approved.
详细描述
The natural next step in this program of research is to investigate interventions for reversing pharyngeal sarcopenia with the ultimate goal of developing novel therapeutic strategies to address this pervasive clinical issue. The exercise science literature suggests that sarcopenia in the limb muscles can be reversed through a combination of rigorous exercise and adequate levels of dietary protein. The innovative multi-disciplinary protocol, PEPP (Pharyngeal Exercises Plus Protein), combines pharyngeal swallowing exercises selected for their known activation of the pharyngeal muscles with daily supplemental protein drinks. The research lab had documented successful improvements to swallowing physiology and pharyngeal sarcopenia in a pilot series of 5 older women using PEPP. However the research was abruptly halted due to both ethical and feasibility challenges posed by the COVID-19 pandemic. In response to these challenges, this study is seeking to establish the feasibility and effectiveness when the PEPP intervention is delivered using telehealth (telePEPP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 and older
- •SARC-F score of ≥4
- •Functional hearing and vision status
- •Access to reliable internet connection
- •Availability of caregiver/family support and/or comfort with independent technology usage
排除标准
- •Known structural or neurological causes of dysphagia
- •Not suitable to consume high levels of protein supplementation (i.e. moderate to severe kidney dysfunction)
结局指标
主要结局
Measurement of pharyngeal constriction before intervention
时间窗: Session 0 (Day 0 pre-intervention visit)
2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Measurement of pharyngeal shortening before intervention
时间窗: Session 0 (Day 0 pre-intervention visit)
2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention
Measurement of pharyngeal constriction after intervention
时间窗: Session 17 (9 week post-intervention visit)
2D lateral videofluoroscopic images will be used to measure pharyngeal constriction pre and post intervention
Measurement of pharyngeal shortening after intervention
时间窗: Session 17 (9 week post-intervention visit)
2D lateral videofluoroscopic images will be used to measure pharyngeal shortening pre and post intervention
次要结局
- Measurement of pharyngeal wall thickness before intervention(Session 0 (Day 0 pre-intervention visit))
- Measurement of pharyngeal wall thickness after intervention(Session 17 (9 week post-intervention visit))
- Measurement of pharyngeal volume before intervention(Session 0 (Day 0 pre-intervention visit))
- Measurement of pharyngeal volume after intervention(Session 17 (9 week post-intervention visit))