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Recruiting Not applicable

Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

NCT05935618 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2023-08-07
Last updated
2025-03-14

Condition(s) studied

Dysphagia, OropharyngealDeglutition Disorders

Investigational drug(s) / intervention(s)

ACT-ING program ( Activity-based skill- and strength training to improve ingestion)

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).

Study 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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Esophageal dysphagia. * Progressive neurologenic dysphagia. * Psychiatric illness. * Delirious. * Infections that requires isolation. * Need for palliative care.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Copenhagen University Hospital, Amager and Hvidovre Hvidovre Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05935618 on ClinicalTrials.gov ↗ ← All trials in Denmark