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NCT Number: NCT05935618

Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital, Amager and Hvidovre

Hvidovre, 2650, Denmark

Location status: Recruiting

Location contact

Tina Hansen, PhD

CONTACT

[email protected]

+4529243586

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Functional Oral Intake Scale (FOIS)

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

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

  2. Nordic Orofacial Test - screening (NOT-S)

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

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

  3. Mini Nutritional Assessment-Short Form

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

    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.

  4. Iowa Oral Performance Instrument (IOPI)

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

    Continuous measure of tongue strength in Kilopascals (KpA).

  5. Self-reported swallowing difficulties

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

    100 mm VAS scale (left side = no difficulties and right side = unable to swallow).

  6. Emotional wellbeing and global quality of life

    Time frame: At end of treatment at 8 weeks

    Two single VAS items using a horizontal line from 0 (worst imaginable emotional well-being / worst imaginable quality of life) to 100 mm (perfect emotional wellbeing /perfect quality of life).

  7. Basic psychological needs in exercise scale (BPNES)

    Time frame: At end of treatment at 8 weeks

    A self-report measure with a total score range of 12 to 60, where higher scores indicate higher levels of autonomy support.

Other outcomes

  1. SARC-F questionnaire

    Time frame: At enrollment

    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

  2. Handgrip strength

    Time frame: At enrollment

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

  3. Mid-upper arm circumference (MUAC)

    Time frame: At enrollment

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

  4. The Global Rating of Change scale (GRoC)

    Time frame: End of treatment at 8 weeks

    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").

  5. Adverse event

    Time frame: End of treatment at 8 weeks

    Aspiration pneumonia

Study contacts

Contact information is provided by the study sponsor or research team.

Tina Hansen, PhD

CONTACT

[email protected]

+45 29243586

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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