Occupational Therapy Rehabilitation for Frail Elders With Dysphagia
Primary Purpose
Dysphagia, Oropharyngeal, Deglutition Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ACT-ING program ( Activity-based skill- and strength training to improve ingestion)
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia, Oropharyngeal
Eligibility Criteria
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.
Sites / Locations
- Copenhagen University Hospital, Amager and HvidovreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combined skill- and strength-based swallowing exercise
Arm Description
The intervention is delivered as face-to-face therapy 2 times per week in 8 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
Nordic Orofacial Test - screening (NOT-S)
Physical examination of orofacial function. The score range from 0 to 6, where higher score indicate impaired function.
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.
Iowa Oral Performance Instrument (IOPI)
Continuous measure of tongue strength in Kilopascals (KpA).
Self-reported swallowing difficulties
100 mm VAS scale (left side = no difficulties and right side = unable to swallow).
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).
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.
Full Information
NCT ID
NCT05935618
First Posted
June 29, 2023
Last Updated
September 21, 2023
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05935618
Brief Title
Occupational Therapy Rehabilitation for Frail Elders With Dysphagia
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?
Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?
Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Oropharyngeal, Deglutition Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined skill- and strength-based swallowing exercise
Arm Type
Experimental
Arm Description
The intervention is delivered as face-to-face therapy 2 times per week in 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
ACT-ING program ( Activity-based skill- and strength training to improve ingestion)
Intervention Description
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 Outcome Measure Information:
Title
The McGill Ingestive Skills Assessment-version 2 (MISA2).
Description
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 Outcome Measure Information:
Title
Functional Oral Intake Scale (FOIS)
Description
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
Title
Nordic Orofacial Test - screening (NOT-S)
Description
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
Title
Mini Nutritional Assessment-Short Form
Description
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
Title
Iowa Oral Performance Instrument (IOPI)
Description
Continuous measure of tongue strength in Kilopascals (KpA).
Time Frame
From enrollment to the end of treatment at 8 weeks
Title
Self-reported swallowing difficulties
Description
100 mm VAS scale (left side = no difficulties and right side = unable to swallow).
Time Frame
From enrollment to the end of treatment at 8 weeks
Title
Emotional wellbeing and global quality of life
Description
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).
Time Frame
At end of treatment at 8 weeks
Title
Basic psychological needs in exercise scale (BPNES)
Description
A self-report measure with a total score range of 12 to 60, where higher scores indicate higher levels of autonomy support.
Time Frame
At end of treatment at 8 weeks
Other Pre-specified Outcome Measures:
Title
SARC-F questionnaire
Description
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
Title
Handgrip strength
Description
Continous measures provided with a dynanometer and used as an indicator of signs of sarcopenia
Time Frame
At enrollment
Title
Mid-upper arm circumference (MUAC)
Description
Anthropometric indicator for sarcopenia. Cut-off points of <25 cm (Female) and <31 cm (Male) are used.
Time Frame
At enrollment
Title
The Global Rating of Change scale (GRoC)
Description
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
Title
Adverse event
Description
Aspiration pneumonia
Time Frame
End of treatment at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Hansen, PhD
Phone
+45 29243586
Email
tina.hansen.18@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Hansen, PhD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital, Amager and Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Hansen, PhD
Phone
+4529243586
Email
tina.hansen.18@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
37102970
Citation
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.
Results Reference
background
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Occupational Therapy Rehabilitation for Frail Elders With Dysphagia
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