Feasibility and Impact of Resistance Training for Sarcopenic Dysphagia

Study Overview
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Brief Summary
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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.

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

Conditions
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Sarcopenia, Dysphagia

Intervention / Treatment
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* Behavioral: activity-based resistance training of ingestive skills (ACT-ING-program)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Dysphagia related to the esophagus Psychiatric diagnosis Neurodegenerative disease or Needs palliative care Admitted to hospital from a nursing home.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: activity-based resistance training of ingestive skills (ACT-ING-program)|The ACT-ING program is based on a task-oriented approach within motor behavior theories and combines resistance training principles with goal-directed and task-specific swallowing exercises in eating and drinking activities through a client-centered procedure informed by self-determination theory.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention tolerance | 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. | During two therapy sessions per week in 12 weeks | 
| Adverse effects | Any expected and unintended events during the therapy sessions and the self-training are recorded. | During two therapy sessions per week in 12 weeks | 
| Intervention usefulness | 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. | Up to 12 weeks | 
| Acceptability | Semi-structured interviews based on the Theoretical Framework of Acceptability | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional wellbeing and global quality of life | Two single VAS items using a horizontal line from 0 (worst imaginable emotional well-being / worst imaginable quality of life) to 100 mm (perfect emotional wellbeing /perfect quality of life). | Baseline and up to 12 weeks | 
| Mealtime performance | The McGill Ingestive Skills Assessment-version 2 (MISA2). The total score range from 36-108, where higher score indicate higher performance | Baseline and up to 12 weeks | 
| Functional oral intake | Functional Oral Intake Scale (FOIS) with a score range of 1( no oral intake) to 7 (Total oral diet with no restrictions). | Baseline and up to 12 weeks | 
| Nutritional status | The modified Mini Nutritional Assessment Scale-Short Form (MNA-SF). The total score range from 0 to 14, where a score <8 indicates malnutrition, 8-11 indicates risk of malnutrition, and >11 indicates no malnutrition. | Baseline and up to 12 weeks | 
| Tongue strength and endurance | Iowa Oral Performance Instrument (IOPI). | Baseline and up to 12 weeks | 
| Intervention progress _ swallow difficulty | Self-reported swallowing difficulty of saliva, liquid and food (100 mm VAS scale (left side = no difficulties and right side = unable to swallow). | During two therapy sessions per week in 12 weeks. | 
| Intervention progress_ intensity | Self-perceived effort from 0 (at rest) to 10 (extremely hard). | During two therapy sessions per week in 12 weeks. | 
| Intervention progress _ Swallow ability | Records on observed number of successful/unsuccessful swallows. | During two therapy sessions per week in 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Sarcopenia, Resistance training, Task-oriented, Skill-based