Feasibility and Impact of Resistance Training for Sarcopenic Dysphagia

Completed

• Conditions: Sarcopenia; Dysphagia

• Registration Number: NCT05269758
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-08
• Primary Completion: 2023-01-06
• Status Verified: 2023-02
• Study Completion: 2023-02-28
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intervention tolerance	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	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	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	Up to 12 weeks	Semi-structured interviews based on the Theoretical Framework of Acceptability

Secondary Outcome Measures

Name	Time	Method
Functional oral intake	Baseline and up to 12 weeks	Functional Oral Intake Scale (FOIS) with a score range of 1( no oral intake) to 7 (Total oral diet with no restrictions).
Mealtime performance	Baseline and up to 12 weeks	The McGill Ingestive Skills Assessment-version 2 (MISA2). The total score range from 36-108, where higher score indicate higher performance
Nutritional status	Baseline and up to 12 weeks	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.
Intervention progress _ Swallow ability	During two therapy sessions per week in 12 weeks.	Records on observed number of successful/unsuccessful swallows.
Emotional wellbeing and global quality of life	Baseline and up to 12 weeks	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).
Intervention progress_ intensity	During two therapy sessions per week in 12 weeks.	Self-perceived effort from 0 (at rest) to 10 (extremely hard).
Intervention progress _ swallow difficulty	During two therapy sessions per week in 12 weeks.	Self-reported swallowing difficulty of saliva, liquid and food (100 mm VAS scale (left side = no difficulties and right side = unable to swallow).
Tongue strength and endurance	Baseline and up to 12 weeks	Iowa Oral Performance Instrument (IOPI).

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark