Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

NCT05935618 | Recruiting

• 1 other identifier: H-23026101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?
2. 2.Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?
3. 3.Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?
4. 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?

Conditions

Dysphagia, Oropharyngeal; Deglutition Disorders

Outcome Measures

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

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (7)

• Functional Oral Intake Scale (FOIS)

  From enrollment to the end of treatment at 8 weeks

• Nordic Orofacial Test - screening (NOT-S)

  From enrollment to the end of treatment at 8 weeks

• Mini Nutritional Assessment-Short Form

  From enrollment to the end of treatment at 8 weeks

• Iowa Oral Performance Instrument (IOPI)

  From enrollment to the end of treatment at 8 weeks

• Self-reported swallowing difficulties

  From enrollment to the end of treatment at 8 weeks

Other Outcomes (5)

• SARC-F questionnaire

  At enrollment

• Handgrip strength

  At enrollment

• Mid-upper arm circumference (MUAC)

  At enrollment

Study Arms (1)

Combined skill- and strength-based swallowing exercise

EXPERIMENTAL

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)

Interventions

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).

Combined skill- and strength-based swallowing exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Esophageal dysphagia.
• Progressive neurologenic dysphagia.
• Psychiatric illness.
• Delirious.
• Infections that requires isolation.
• Need for palliative care.

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Copenhagen University Hospital, Amager and Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Tina Hansen, PhD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina Hansen, PhD

CONTACT

+45 29243586; tina.hansen.18@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: August 7, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)