A Single-center Randomized Clinical Trial to Test the Efficacy of Pharyngeal Swallowing Exercises (With or Without Protein Supplementation) to Build Pharyngeal Muscular Reserve in Pre-frail Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Thickness of the Superior Pharyngeal Constrictor Muscle
研究概览
简要总结
The swallowing muscles are prone to decreased strength and function as part of the natural aging process which can lead to difficulty swallowing, malnutrition, and frailty. Exercise and nutrition are powerful stimulators of muscular change. The proposed research will investigate the effectiveness of a 12-week proactive regimen of swallowing exercises (with or without daily protein supplement drinks) to improve the composition, force, and physiology of the swallowing muscles and explore the relationship to overall health and physical function in 80 community-dwelling older adults. Each participant will serve as their own control for 12 weeks before being randomized to complete swallowing exercises alone or swallowing exercises with protein drinks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The PI, outcome assessors, and individuals conducting data analyses will be blinded to randomization. The treating clinicians and participants will be aware of their study group given that they will be provided with either water or protein drinks.
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
- •Participants must be 65 years of age or older.
- •Participants must score a 1 or 2 on the FRAIL scale OR a 4 or greater on the Strength, Assistance in Walking, Rise from a Chair, Climb Stairs and Falls (SARC-F) Questionnaire.
- •Participants must score 26 or greater on the Montreal Cognitive Assessment (MoCA).
- •Willingness to participate in the study procedures.
排除标准
- •Known structural or neurological causes of dysphagia.
- •Cannot consume high levels of protein (Chronic Kidney Disease Stage 3 or higher).
- •Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems).
研究组 & 干预措施
Control, then Swallowing Exercises + Protein
Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."
干预措施: Pharyngeal Swallowing Exercises (Behavioral)
Control, then Swallowing Exercises + Protein
Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."
干预措施: Protein Supplementation (Dietary Supplement)
Control, then Swallowing Exercises + Protein
Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."
干预措施: MRI (Device)
Control, then Swallowing Exercises
Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity."
干预措施: Pharyngeal Swallowing Exercises (Behavioral)
Control, then Swallowing Exercises
Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity."
干预措施: MRI (Device)
结局指标
主要结局
Change in Thickness of the Superior Pharyngeal Constrictor Muscle
时间窗: Baseline, Week 28
Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the superior pharyngeal constrictor muscle.
Change in Thickness of the Middle Pharyngeal Constrictor Muscle
时间窗: Baseline, Week 28
Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the middle pharyngeal constrictor muscle.
Change in Thickness of the Inferior Pharyngeal Constrictor Muscle
时间窗: Baseline, Week 28
Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the inferior pharyngeal constrictor muscle.
Change in Maximum Pharyngeal Constriction During Swallowing
时间窗: Baseline, Week 28
Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy.
次要结局
- Change in Short Physical Performance Battery (SPPB) Scores(Baseline, Week 28)
- Change in Fat-Free Muscle Index(Baseline, Week 28)
- Change in Pre-Albumin Levels(Baseline, Week 28)