Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHvidovre University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Esophageal dysphagia.

Progressive neurologenic dysphagia.

Psychiatric illness.

Delirious.

Trial design

Design model

Single group

Treatments tested in this trial

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

    Behavioral

    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).

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Combined skill- and strength-based swallowing exerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The McGill Ingestive Skills Assessment-version 2 (MISA2).

Maasure of meal-time task performance. The total score range from 36-108, where higher score indicate higher performance

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

1

Functional Oral Intake Scale (FOIS)

Functional Oral Intake with a score range of 1( no oral intake) to 7 (Total oral diet with no restrictions).

Time frame
From enrollment to the end of treatment at 8 weeks
2

Nordic Orofacial Test - screening (NOT-S)

Physical examination of orofacial function. The score range from 0 to 6, where higher score indicate impaired function.

Time frame
From enrollment to the end of treatment at 8 weeks
3

Mini Nutritional Assessment-Short Form

The total score range from 0 to 14, where a score \<8 indicates malnutrition, 8-11 indicates risk of malnutrition, and \>11 indicates no malnutrition.

Time frame
From enrollment to the end of treatment at 8 weeks
4

Iowa Oral Performance Instrument (IOPI)

Continuous measure of tongue strength in Kilopascals (KpA).

Time frame
From enrollment to the end of treatment at 8 weeks

Other outcomes

1

SARC-F questionnaire

A screening tool to identify probable sarcopenia. The score range from 0 to 10. A score equal to or greater than 4 is predictive of sarcopenia

Time frame
At enrollment
2

Handgrip strength

Continous measures provided with a dynanometer and used as an indicator of signs of sarcopenia

Time frame
At enrollment
3

Mid-upper arm circumference (MUAC)

Anthropometric indicator for sarcopenia. Cut-off points of \<25 cm (Female) and \<31 cm (Male) are used.

Time frame
At enrollment
4

The Global Rating of Change scale (GRoC)

A single, self-administered question asking participants to rate how their condition has changed since the start of intervention. The scores range from -3 (labeled "worse") on the left and +3 (labeled "better") on the right, and 0 in the middle (labeled "no change").

Time frame
End of treatment at 8 weeks

Sponsors and contacts

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