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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05269758
Other study ID # H-19039031
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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