Occupational Therapy Rehabilitation for Frail Elders with Dysphagia
- Conditions
- Deglutition DisordersDysphagia, Oropharyngeal
- Interventions
- Behavioral: ACT-ING program ( Activity-based skill- and strength training to improve ingestion)
- Registration Number
- NCT05935618
- Lead Sponsor
- Hvidovre University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
-
A score of 5-18 on the Gugging Swallowing Screen.
-
Speaks and understands Danish.
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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.
- Esophageal dysphagia.
- Progressive neurologenic dysphagia.
- Psychiatric illness.
- Delirious.
- Infections that requires isolation.
- Need for palliative care.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combined skill- and strength-based swallowing exercise ACT-ING program ( Activity-based skill- and strength training to improve ingestion) The intervention is delivered as face-to-face therapy 2 times per week in 8 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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).
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).
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.
Iowa Oral Performance Instrument (IOPI) From enrollment to the end of treatment at 8 weeks Continuous measure of tongue strength in Kilopascals (KpA).
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).
Trial Locations
- Locations (1)
Copenhagen University Hospital, Amager and Hvidovre
🇩🇰Hvidovre, Denmark