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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined skill- and strength-based swallowing exercise | Experimental | The intervention is delivered as face-to-face therapy 2 times per week in 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-ING program ( Activity-based skill- and strength training to improve ingestion) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The 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 | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of treatment at 8 weeks |
| Nordic Orofacial Test - screening (NOT-S) |
| Measure | Description | Time Frame |
|---|---|---|
| SARC-F questionnaire | 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 | At enrollment |
| Handgrip strength | Continous measures provided with a dynanometer and used as an indicator of signs of sarcopenia |
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tina Hansen, PhD | Contact | +45 29243586 | tina.hansen.18@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Tina Hansen, PhD | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Amager and Hvidovre | Recruiting | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37102970 | Background | Hansen T, Laursen LB, Hansen MS. Early Feasibility of an Activity-Based Intervention for Improving Ingestive Functions in Older Adults with Oropharyngeal Dysphagia. Geriatrics (Basel). 2023 Apr 19;8(2):44. doi: 10.3390/geriatrics8020044. |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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|
Physical examination of orofacial function. The score range from 0 to 6, where higher score indicate impaired function.
| 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. | From enrollment to the end of treatment at 8 weeks |
| Iowa Oral Performance Instrument (IOPI) | Continuous measure of tongue strength in Kilopascals (KpA). | 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). | 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). | 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. | At end of treatment at 8 weeks |
| At enrollment |
| Mid-upper arm circumference (MUAC) | Anthropometric indicator for sarcopenia. Cut-off points of <25 cm (Female) and <31 cm (Male) are used. | At enrollment |
| The Global Rating of Change scale (GRoC) | 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"). | End of treatment at 8 weeks |
| Adverse event | Aspiration pneumonia | End of treatment at 8 weeks |
| D010038 | Otorhinolaryngologic Diseases |