The goal of this proof-of-concept study is to assess the potential of a newly developed intervention with combined skill- and strength-based principles for maximizing swallowing-related outcomes and prevent further weakening of the swallowing muscles in older people with dysphagia (difficulty swallowing). The main questions to be answered are: 1. Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia? 2. Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia? 3. Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia? 4. Is there an association between perceived autonomy support and intervention engagement when older individuals with dysphagia receive the intervention during hospitalization and continued in community-based rehabilitation after discharge? Participants will be asked to perform goal-directed and task-specific swallowing exercises in eating and drinking activities where the intensity variables include advancing steps of an altered bolus volume and consistency according to a 17-level task hierarchy, which are introduced according to predetermined progression rules, as well as increases in swallowing repetitions. The dosage is 2-3 individual, face-to-face therapy sessions per week for up to a maximum of eight weeks. A therapy session lasts up to 45 min. In between therapy sessions, participants integrate the achieved level from therapy into their daily meals as self-training.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The intervention is based on a client-centered Occupational therapy task-oriented approach, in which real objects are employed in a realistic context. The intervention uses the effortful swallowing in combination with advancing steps of liquid and food items as resistive forces to challenge the swallow in a safe environment during eating and drinking activities. Progression is realized based on pre-determined progression rules to ensure the right challenges in combination with safety (Hansen et al, 2023).
Copenhagen University Hospital, Amager and Hvidovre
Hvidovre, Denmark
RECRUITINGThe McGill Ingestive Skills Assessment-version 2 (MISA2).
Maasure of meal-time task performance. The total score range from 36-108, where higher score indicate higher performance
Time frame: From enrollment to the end of treatment at 8 weeks
Functional Oral Intake Scale (FOIS)
Functional Oral Intake with a score range of 1( no oral intake) to 7 (Total oral diet with no restrictions).
Time frame: From enrollment to the end of treatment at 8 weeks
Nordic Orofacial Test - screening (NOT-S)
Physical examination of orofacial function. The score range from 0 to 6, where higher score indicate impaired function.
Time frame: From enrollment to the end of treatment at 8 weeks
Mini Nutritional Assessment-Short Form
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.
Time frame: From enrollment to the end of treatment at 8 weeks
Iowa Oral Performance Instrument (IOPI)
Continuous measure of tongue strength in Kilopascals (KpA).
Time frame: From enrollment to the end of treatment at 8 weeks
Self-reported swallowing difficulties
100 mm VAS scale (left side = no difficulties and right side = unable to swallow).
Time frame: From enrollment to the end of treatment at 8 weeks
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).
Time frame: At end of treatment at 8 weeks
Basic psychological needs in exercise scale (BPNES)
A self-report measure with a total score range of 12 to 60, where higher scores indicate higher levels of autonomy support.
Time frame: At end of treatment at 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.