Feasibility and Impact of Resistance Training for Sarcopenic Dysphagia

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269758
• Other study ID #: H-19039031
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 28, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demand for the intervention by the target group	Records of recruitment/attrition rates.	Though study completion, an average of three years.
Other	Intervention functionality	Records of numbers of complete/incomplete therapy sessions.	Though study completion, an average of three years.
Other	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.
Other	Determinants for delivering the ACT-ING program by practitioners	Semi-structured interview based on the Theoretical Domains Framework	Up to 12 weeks.
Primary	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
Primary	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
Primary	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
Primary	Acceptability	Semi-structured interviews based on the Theoretical Framework of Acceptability	Up to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Tongue strength and endurance	Iowa Oral Performance Instrument (IOPI).	Baseline and up to 12 weeks
Secondary	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.
Secondary	Intervention progress_ intensity	Self-perceived effort from 0 (at rest) to 10 (extremely hard).	During two therapy sessions per week in 12 weeks.
Secondary	Intervention progress _ Swallow ability	Records on observed number of successful/unsuccessful swallows.	During two therapy sessions per week in 12 weeks.