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临床试验/NCT05269758
NCT05269758已完成不适用

Feasibility and Impact of an Activity-based Intervention for Strengthening Ingestive Functions in Elders With Sarcopenic Dysphagia: a Multiple-case Study

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Intervention tolerance

研究概览

简要总结

The purpose of the study is to test and optimize the feasibility of an activity-based resistance training program for patients with sarcopenic dysphagia. The study is a feasibility study designed as a multiple-case study with quantitative and qualitative data sources related to a number of feasibility outcomes and clinical outcomes during and after the intervention. Participants are 15 patients> 65 years of age are referred for dysphagia assessment by an Occupational Therapist (patients may be admitted to several different wards (endocrinology, pulmonary medicine, infectious medicine, gastrology). The intervention is offered during hospitalization and after discharge for a maximum of 12 weeks.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Speaks and understand Danish language, and able to provide written informed consent for participation
  • Dysphagia verified by a Gugging Swallowing Screen
  • Generalized sarcopenia determined by a Danish version of the questionnaire SARC-F
  • Sarcopenia of the swallowing mechanism indicated by reduced tongue strength measured with the Iowa Oral Performance Instrument

排除标准

  • Dysphagia related to the esophagus
  • Psychiatric diagnosis
  • Neurodegenerative disease or
  • Needs palliative care
  • Admitted to hospital from a nursing home.

结局指标

主要结局

Intervention tolerance

时间窗: During two therapy sessions per week in 12 weeks

Time-series of participants rated level of concern for aspiration on a 100 mm VAS-scale ((left side = no concerns and right side = maximal concerns). The success criterion is that 80% of the VAS scales are in the area of 'no concerns' for aspiration.

Intervention usefulness

时间窗: Up to 12 weeks

Participant self-report on the subscale 'Value/usefulness' from the Intrinsic Motivation Inventory (IMI). The subscale covers 7 items to be rated on a 7-point Likert scale (1=Not at all true to 7=very true). A high score indicate high usability.

Adverse effects

时间窗: During two therapy sessions per week in 12 weeks

Any expected and unintended events during the therapy sessions and the self-training are recorded.

Acceptability

时间窗: Up to 12 weeks

Semi-structured interviews based on the Theoretical Framework of Acceptability

次要结局

  • Functional oral intake(Baseline and up to 12 weeks)
  • Mealtime performance(Baseline and up to 12 weeks)
  • Nutritional status(Baseline and up to 12 weeks)
  • Intervention progress _ Swallow ability(During two therapy sessions per week in 12 weeks.)
  • Emotional wellbeing and global quality of life(Baseline and up to 12 weeks)
  • Intervention progress_ intensity(During two therapy sessions per week in 12 weeks.)
  • Intervention progress _ swallow difficulty(During two therapy sessions per week in 12 weeks.)
  • Tongue strength and endurance(Baseline and up to 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tina Hansen, PhD, MSc.OT

Senior Researcher

Hvidovre University Hospital

研究点 (1)

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