Copenhagen University Hospital, Amager and Hvidovre
Hvidovre, 2650, Denmark
Location status: Recruiting
NCT Number: NCT05935618
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Hvidovre, 2650, Denmark
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 8 weeks
Continuous measure of tongue strength in Kilopascals (KpA).
Time frame: From enrollment to the end of treatment at 8 weeks
100 mm VAS scale (left side = no difficulties and right side = unable to swallow).
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: At enrollment
Continous measures provided with a dynanometer and used as an indicator of signs of sarcopenia
Time frame: At enrollment
Anthropometric indicator for sarcopenia. Cut-off points of <25 cm (Female) and <31 cm (Male) are used.
Time frame: 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").
Time frame: End of treatment at 8 weeks
Aspiration pneumonia
Contact information is provided by the study sponsor or research team.
Hvidovre University Hospital
Other
No Food or Drink Does Any Good Until It is Swallowed: a Proof-of-concept Study on Occupational Therapy Rehabilitation for Frail Elders with Dysphagia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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