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Clinical Trials/NCT05269758
NCT05269758
Completed
Not Applicable

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

Hvidovre University Hospital1 site in 1 country11 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Hvidovre University Hospital
Enrollment
11
Locations
1
Primary Endpoint
Intervention tolerance
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
February 28, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tina Hansen, PhD, MSc.OT

Senior Researcher

Hvidovre University Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Intervention tolerance

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Up to 12 weeks

Semi-structured interviews based on the Theoretical Framework of Acceptability

Secondary Outcomes

  • Functional oral intake(Baseline and up to 12 weeks)
  • Mealtime performance(Baseline and up to 12 weeks)
  • Nutritional status(Baseline and up to 12 weeks)
  • Intervention progress _ Swallow ability(During two therapy sessions per week in 12 weeks.)
  • Emotional wellbeing and global quality of life(Baseline and up to 12 weeks)
  • Intervention progress_ intensity(During two therapy sessions per week in 12 weeks.)
  • Intervention progress _ swallow difficulty(During two therapy sessions per week in 12 weeks.)
  • Tongue strength and endurance(Baseline and up to 12 weeks)

Study Sites (1)

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