Occupational Therapy Rehabilitation for Frail Elders with Dysphagia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACT-ING program ( Activity-based skill- and strength training to improve ingestion).
- Who it may be relevant to
- Registry conditions: Dysphagia, Oropharyngeal, Deglutition Disorders. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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
Primary outcome measures
- The McGill Ingestive Skills Assessment-version 2 (MISA2). [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (7)
- Functional Oral Intake Scale (FOIS) [Time frame: From enrollment to the end of treatment at 8 weeks]
- Nordic Orofacial Test - screening (NOT-S) [Time frame: From enrollment to the end of treatment at 8 weeks]
- Mini Nutritional Assessment-Short Form [Time frame: From enrollment to the end of treatment at 8 weeks]
- Iowa Oral Performance Instrument (IOPI) [Time frame: From enrollment to the end of treatment at 8 weeks]
- Self-reported swallowing difficulties [Time frame: From enrollment to the end of treatment at 8 weeks]
- Emotional wellbeing and global quality of life [Time frame: At end of treatment at 8 weeks]
- Basic psychological needs in exercise scale (BPNES) [Time frame: At end of treatment at 8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Copenhagen University Hospital, Amager and Hvidovre — Hvidovre
Publications
- Hansen T, Laursen LB, Hansen MS. Early Feasibility of an Activity-Based Intervention for Improving Ingestive Functions in Older Adults with Oropharyngeal Dysphagia. Geriatrics (Basel). 2023 Apr 19;8(2):44. doi: 10.3390/geriatrics8020044. PMID 37102970
Identifiers
NCT: NCT05935618 · H-23026101