Clinical trial NCT05269758: Feasibility and Impact of Resistance Training for Sarcopenic Dysphagia
Official title: Feasibility and Impact of an Activity-based Intervention for Strengthening Ingestive Functions in Elders With Sarcopenic Dysphagia: a Multiple-case Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Dysphagia
Keywords: Dysphagia
Sarcopenia
Resistance training
Task-oriented
Skill-based
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 11
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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 .

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.


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.

Primary outcomes:
measure: Intervention tolerance
timeFrame: During two therapy sessions per week in 12 weeks
measure: Adverse effects
timeFrame: During two therapy sessions per week in 12 weeks
measure: Intervention usefulness
timeFrame: Up to 12 weeks
measure: Acceptability
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Emotional wellbeing and global quality of life
timeFrame: Baseline and up to 12 weeks
measure: Mealtime performance
timeFrame: Baseline and up to 12 weeks
measure: Functional oral intake
timeFrame: Baseline and up to 12 weeks
measure: Nutritional status
timeFrame: Baseline and up to 12 weeks
measure: Tongue strength and endurance
timeFrame: Baseline and up to 12 weeks
measure: Intervention progress _ swallow difficulty
timeFrame: During two therapy sessions per week in 12 weeks.
measure: Intervention progress_ intensity
timeFrame: During two therapy sessions per week in 12 weeks.
measure: Intervention progress _ Swallow ability
timeFrame: During two therapy sessions per week in 12 weeks.
Other outcomes:
measure: Demand for the intervention by the target group
timeFrame: Though study completion, an average of three years.
measure: Intervention functionality
timeFrame: Though study completion, an average of three years.
measure: Intervention adaptations
timeFrame: During two therapy sessions per week in 12 weeks.
measure: Determinants for delivering the ACT-ING program by practitioners
timeFrame: Up to 12 weeks.
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References: