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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Denmark
Copenhagen University Hospital, Amager and Hvidovre
RECRUITING
Hvidovre
Contact Information
Primary
Tina Hansen, PhD
tina.hansen.18@regionh.dk
+45 29243586
Time Frame
Start Date: 2023-08-07
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Combined skill- and strength-based swallowing exercise
The intervention is delivered as face-to-face therapy 2 times per week in 8 weeks
Related Therapeutic Areas
Sponsors
Leads: Hvidovre University Hospital

This content was sourced from clinicaltrials.gov