Deglutition Disorders, Dysphagia, Oropharyngeal
Conditions
Brief summary
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.
Interventions
BEHAVIORALACT-ING program ( Activity-based skill- and strength training to improve ingestion)
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).
Sponsors
Hvidovre University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A score of 5-18 on the Gugging Swallowing Screen. * Speaks and understands Danish. * Are able to cooperate in the intervention and give written informed consent; i.e. is oriented in time, place and own data, and able to perform four simple oral motor movements on request. * Has given written informed consent.
Exclusion criteria
* Esophageal dysphagia. * Progressive neurologenic dysphagia. * Psychiatric illness. * Delirious. * Infections that requires isolation. * Need for palliative care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The McGill Ingestive Skills Assessment-version 2 (MISA2). | From enrollment to the end of treatment at 8 weeks | Maasure of meal-time task performance. The total score range from 36-108, where higher score indicate higher performance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nordic Orofacial Test - screening (NOT-S) | From enrollment to the end of treatment at 8 weeks | Physical examination of orofacial function. The score range from 0 to 6, where higher score indicate impaired function. |
| Mini Nutritional Assessment-Short Form | From enrollment to the end of treatment at 8 weeks | 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. |
| Iowa Oral Performance Instrument (IOPI) | From enrollment to the end of treatment at 8 weeks | Continuous measure of tongue strength in Kilopascals (KpA). |
| Self-reported swallowing difficulties | From enrollment to the end of treatment at 8 weeks | 100 mm VAS scale (left side = no difficulties and right side = unable to swallow). |
| Emotional wellbeing and global quality of life | At end of treatment at 8 weeks | 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). |
| Basic psychological needs in exercise scale (BPNES) | At end of treatment at 8 weeks | A self-report measure with a total score range of 12 to 60, where higher scores indicate higher levels of autonomy support. |
| Functional Oral Intake Scale (FOIS) | From enrollment to the end of treatment at 8 weeks | Functional Oral Intake with a score range of 1( no oral intake) to 7 (Total oral diet with no restrictions). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mid-upper arm circumference (MUAC) | At enrollment | Anthropometric indicator for sarcopenia. Cut-off points of \<25 cm (Female) and \<31 cm (Male) are used. |
| The Global Rating of Change scale (GRoC) | End of treatment at 8 weeks | A single, self-administered question asking participants to rate how their condition has changed since the start of intervention. The scores range from -3 (labeled worse) on the left and +3 (labeled better) on the right, and 0 in the middle (labeled no change). |
| Adverse event | End of treatment at 8 weeks | Aspiration pneumonia |
| Handgrip strength | At enrollment | Continous measures provided with a dynanometer and used as an indicator of signs of sarcopenia |
| SARC-F questionnaire | At enrollment | A screening tool to identify probable sarcopenia. The score range from 0 to 10. A score equal to or greater than 4 is predictive of sarcopenia |
Countries
Denmark
Contacts
Primary ContactTina Hansen, PhD
Outcome results
None listed