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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05269758
Enrollment
11
Registered
2022-03-08
Start date
2020-12-01
Completion date
2023-02-28
Last updated
2023-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Sarcopenia

Keywords

Dysphagia, Sarcopenia, Resistance training, Task-oriented, Skill-based

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.

Interventions

BEHAVIORALactivity-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.

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intervention toleranceDuring two therapy sessions per week in 12 weeksTime-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 usefulnessUp to 12 weeksParticipant 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 effectsDuring two therapy sessions per week in 12 weeksAny expected and unintended events during the therapy sessions and the self-training are recorded.
AcceptabilityUp to 12 weeksSemi-structured interviews based on the Theoretical Framework of Acceptability

Secondary

MeasureTime frameDescription
Nutritional statusBaseline and up to 12 weeksThe 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 difficultyDuring 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).
Intervention progress_ intensityDuring two therapy sessions per week in 12 weeks.Self-perceived effort from 0 (at rest) to 10 (extremely hard).
Intervention progress _ Swallow abilityDuring two therapy sessions per week in 12 weeks.Records on observed number of successful/unsuccessful swallows.
Tongue strength and enduranceBaseline and up to 12 weeksIowa Oral Performance Instrument (IOPI).
Emotional wellbeing and global quality of lifeBaseline and up to 12 weeksTwo 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).
Mealtime performanceBaseline and up to 12 weeksThe McGill Ingestive Skills Assessment-version 2 (MISA2). The total score range from 36-108, where higher score indicate higher performance
Functional oral intakeBaseline and up to 12 weeksFunctional Oral Intake Scale (FOIS) with a score range of 1( no oral intake) to 7 (Total oral diet with no restrictions).

Other

MeasureTime frameDescription
Demand for the intervention by the target groupThough study completion, an average of three years.Records of recruitment/attrition rates.
Determinants for delivering the ACT-ING program by practitionersUp to 12 weeks.Semi-structured interview based on the Theoretical Domains Framework
Intervention adaptationsDuring two therapy sessions per week in 12 weeks.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.
Intervention functionalityThough study completion, an average of three years.Records of numbers of complete/incomplete therapy sessions.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026