Occupational Therapy Rehabilitation for Frail Elders With Dysphagia
Study Details
Study Description
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:
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Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?
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Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?
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Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?
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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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Combined skill- and strength-based swallowing exercise The intervention is delivered as face-to-face therapy 2 times per week in 8 weeks |
Behavioral: ACT-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).
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
Other Outcome Measures
- 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
- Handgrip strength [At enrollment]
Continous measures provided with a dynanometer and used as an indicator of signs of sarcopenia
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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A score of 5-18 on the Gugging Swallowing Screen.
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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.
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Has given written informed consent.
Exclusion Criteria:
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Esophageal dysphagia.
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Progressive neurologenic dysphagia.
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Psychiatric illness.
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Delirious.
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Infections that requires isolation.
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Need for palliative care.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Copenhagen University Hospital, Amager and Hvidovre | Hvidovre | Denmark | 2650 |
Sponsors and Collaborators
- Hvidovre University Hospital
Investigators
- Principal Investigator: Tina Hansen, PhD, Hvidovre University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- H-23026101