Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT05935618

Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

Led by Hvidovre University Hospital · Updated on 2025-03-14

30

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A score of 5-18 on the Gugging Swallowing Screen
  • Speaks and understands Danish
  • Able to cooperate in the intervention and give written informed consent
  • Oriented in time, place, and own data
  • Able to perform four simple oral motor movements on request
  • Has given written informed consent
Not Eligible

You will not qualify if you...

  • Esophageal dysphagia
  • Progressive neurologic dysphagia
  • Psychiatric illness
  • Delirium
  • Infections requiring isolation
  • Need for palliative care

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Copenhagen University Hospital, Amager and Hvidovre

Hvidovre, Denmark, 2650

Actively Recruiting

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Research Team

T

Tina Hansen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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