Occupational Therapy Rehabilitation for Frail Elders With Dysphagia

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05935618
Collaborator
(none)
30
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ACT-ING program ( Activity-based skill- and strength training to improve ingestion)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 7, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combined skill- and strength-based swallowing exercise

The intervention is delivered as face-to-face therapy 2 times per week in 8 weeks

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 al, 2023).

Outcome Measures

Primary Outcome Measures

  1. 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

Secondary Outcome Measures

  1. Functional Oral Intake Scale (FOIS) [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) [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 [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) [From enrollment to the end of treatment at 8 weeks]

    Continuous measure of tongue strength in Kilopascals (KpA).

  5. Self-reported swallowing difficulties [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 [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) [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 Outcome Measures

  1. SARC-F questionnaire [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 [At enrollment]

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

  3. Mid-upper arm circumference (MUAC) [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) [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 [End of treatment at 8 weeks]

    Aspiration pneumonia

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Copenhagen University Hospital, Amager and Hvidovre Hvidovre Denmark 2650

Sponsors and Collaborators

  • Hvidovre University Hospital

Investigators

  • Principal Investigator: Tina Hansen, PhD, Hvidovre University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tina Hansen, PhD, MSc.OT, Senior Researcher, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT05935618
Other Study ID Numbers:
  • H-23026101
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 10, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 10, 2023