Swallowing Difficulties in People Over 60 Years: Prevalence, Degree of Difficulty and Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Penetration-aspiration score (PAS)
研究概览
简要总结
Participants included in SCAPIS2 (Swedish Cardio Pulmonary bioimage study) are screened regarding swallowing difficulty using a timed water swallow test. Participants who show signs of swallowing difficulty (dysphagia) are included in the present study, which encompasses s flexible endoscopic evaluation of swallowing function (FEES). Participants showing a moderate-severe dysphagia are randomized into one of three intervention groups: muscle strengthening training, skill-based swallowing training and a control group who will receive compensatory treatment. The study is expected to improve diagnostics and treatment of swallowing difficulties in an ageing population.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation in SCAPIS2
- •Swallowing dysfunction according to timed water swallow test or
- •Swallowing dysfunction according to self-report
排除标准
- •Severely impaired intellectual abilities.
- •Inability to consent to inclusion in the study.
- •Inability to answer written questionnaires in Swedish
- •Inclusion of non-dysphagia control cohort: No signs of aspiration, slow swallowing (<10 ml/sec) or self-rated difficulties with eating and swallowing in sub-study SCAPIS2
研究组 & 干预措施
Muscular strengthening training
The muscular strengthening training is permformed 3 times daily as "head-ups" where the participant lies down and lifts their head anf then holds it upright during 60 seconds. This is repeated x 3 followed by 30 head-lifts. The duration of the training programme is 6 weeks.
干预措施: Muscular strengthening training (Behavioral)
Skill-based training
During the skill-based training programme, food and beverages are used as swallowing training material based on a pre-determined food-hierarchy. The training starts at the highest level that the participant can safely swallow and then progresses as strength and coordination of swallowing improves. This training is comprised of 15 speech- and language pathologist lead training sessions during 3 weeks.
干预措施: Skill-based training (Behavioral)
Compensatory treatment
The control group will receive information about dysphagia and advise on compensatory strategies.
结局指标
主要结局
Penetration-aspiration score (PAS)
时间窗: Baseline to post-intervention (6 weeks)
Ranges from 1-8 where 8 indicates worst possible aspiration score. Swallowing safety measured from Flexible Endoscopic Examination of Swallowing (FEES).
次要结局
- Quality of Life(Up to 12 months post-intervention)
- Dysphagia related symtoms(Up to 12 months post-intervention)
- Tongue strength(Up to 12 months post-intervention)
- Body composition(Up to 12 months post-intervention)
- Cost of intervention(Up to 12 months post-intervention)
- Self-perceived swallowing function(Up to 12 months post-intervention)
- Assessment of swallowing efficiency(Up to 12 months post-intervention)
- Assessment of secretion(Up to 12 months post-intervention)
- Assessment of swallowing initiation(Up to 12 months post-intervention)
- Assessment of overall swallowing function from the FEES(Up to 12 months post-intervention)
研究者
Lisa Tuomi
Speech-language pathologist, associate professor
Sahlgrenska University Hospital, Sweden