Feasibility and Impact of Resistance Training for Sarcopenic Dysphagia

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Dysphagia
• Intervention / Treatment: Behavioral: activity-based resistance training of ingestive skills (ACT-ING-program)

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants admitted to an acute hospital for medical reasons (endocrinology, pulmonary medicine, infectious medicine, gastrology), and referred for dysphagia assessment by an Occupational Therapist .

Description

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 Plan

How is the study designed?

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demand for the intervention by the target group	Records of recruitment/attrition rates.	Though study completion, an average of three years.
Intervention functionality	Records of numbers of complete/incomplete therapy sessions.	Though study completion, an average of three years.
Intervention adaptations	Records on any adaptations (minor or major modifications, addition of new components, or deletions of a component) in the intervention model of the ACT-ING program during therapy. For any adaptations, 'what', 'how' and 'why' are recorded.	During two therapy sessions per week in 12 weeks.
Determinants for delivering the ACT-ING program by practitioners	Semi-structured interview based on the Theoretical Domains Framework	Up to 12 weeks.

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): January 6, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Dysphagia; Sarcopenia; Resistance training; Task-oriented; Skill-based
• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Esophageal Diseases; Muscular Atrophy; Atrophy; Sarcopenia; Deglutition Disorders
• Other Study ID Numbers: H-19039031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No