Clinical trial NCT05935618: Occupational Therapy Rehabilitation for Frail Elders with Dysphagia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia, Oropharyngeal
Deglutition Disorders
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: The McGill Ingestive Skills Assessment-version 2 (MISA2).
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Functional Oral Intake Scale (FOIS)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Nordic Orofacial Test - screening (NOT-S)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Mini Nutritional Assessment-Short Form
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Iowa Oral Performance Instrument (IOPI)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Self-reported swallowing difficulties
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Emotional wellbeing and global quality of life
timeFrame: At end of treatment at 8 weeks
measure: Basic psychological needs in exercise scale (BPNES)
timeFrame: At end of treatment at 8 weeks
Other outcomes:
measure: SARC-F questionnaire
timeFrame: At enrollment
measure: Handgrip strength
timeFrame: At enrollment
measure: Mid-upper arm circumference (MUAC)
timeFrame: At enrollment
measure: The Global Rating of Change scale (GRoC)
timeFrame: End of treatment at 8 weeks
measure: Adverse event
timeFrame: End of treatment at 8 weeks
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital, Amager and Hvidovre
Study officials:
affiliation: Hvidovre University Hospital
name: Tina Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.