Occupational Therapy Rehabilitation for Frail Elders With Dysphagia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Deglutition Disorders; Dysphagia, Oropharyngeal
• Intervention / Treatment: Behavioral: ACT-ING program ( Activity-based skill- and strength training to improve ingestion)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tina Hansen, PhD; Phone Number: +45 29243586; Email: tina.hansen.18@regionh.dk

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Copenhagen University Hospital, Amager and Hvidovre
    • Contact: Tina Hansen, PhD; Phone Number: +4529243586; Email: tina.hansen.18@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of treatment at 8 weeks
Nordic Orofacial Test - screening (NOT-S)	Physical examination of orofacial function. The score range from 0 to 6, where higher score indicate impaired function.	From enrollment to the end of treatment at 8 weeks
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.	From enrollment to the end of treatment at 8 weeks
Iowa Oral Performance Instrument (IOPI)	Continuous measure of tongue strength in Kilopascals (KpA).	From enrollment to the end of treatment at 8 weeks
Self-reported swallowing difficulties	100 mm VAS scale (left side = no difficulties and right side = unable to swallow).	From enrollment to the end of treatment at 8 weeks
Emotional wellbeing and global quality of life	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).	At end of treatment at 8 weeks
Basic psychological needs in exercise scale (BPNES)	A self-report measure with a total score range of 12 to 60, where higher scores indicate higher levels of autonomy support.	At end of treatment at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	Aspiration pneumonia	End of treatment at 8 weeks
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	At enrollment
Handgrip strength	Continous measures provided with a dynanometer and used as an indicator of signs of sarcopenia	At enrollment
Mid-upper arm circumference (MUAC)	Anthropometric indicator for sarcopenia. Cut-off points of <25 cm (Female) and <31 cm (Male) are used.	At enrollment
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").	End of treatment at 8 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: H-23026101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No